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  "result": "{\"content\":\"{\\\"totalCount\\\":55,\\\"studies\\\":[\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07738172\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"202605130RINE\\\"},\\\"organization\\\":{\\\"fullName\\\":\\\"National Taiwan University Hospital\\\",\\\"class\\\":\\\"OTHER\\\"},\\\"briefTitle\\\":\\\"Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer\\\",\\\"officialTitle\\\":\\\"A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy\\\",\\\"acronym\\\":\\\"PTR-2\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-09\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-09-08\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2031-08-01\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2031-08-01\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-07-23\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-07-28\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-07-31\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-09-07\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-09-09\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"PRINCIPAL_INVESTIGATOR\\\",\\\"investigatorFullName\\\":\\\"Statistical Center, NTUHCTC\\\",\\\"investigatorTitle\\\":\\\"National Taiwan University Hospital\\\",\\\"investigatorAffiliation\\\":\\\"National Taiwan University Hospital\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"National Taiwan University Hospital\\\",\\\"class\\\":\\\"OTHER\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":false,\\\"isFdaRegulatedDrug\\\":false,\\\"isFdaRegulatedDevice\\\":false,\\\"isUsExport\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Although osimertinib can provide effective disease control, most patients eventually experience disease progression, and the primary lung tumor may remain an important site of treatment resistance.\\\\n\\\\nThis multicenter, randomized, open-label phase III trial will evaluate whether surgical removal of the primary lung tumor, in addition to continued osimertinib treatment, prolongs progression-free survival in patients with EGFR-mutated oligometastatic non-small cell lung cancer.\\\\n\\\\nAll participants will initially receive osimertinib 80 mg orally once daily for 12 weeks. Participants who have a partial response or stable disease according to RECIST version 1.1 and remain suitable for surgery will be randomly assigned in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib. The study will also evaluate overall survival, safety, pathologic response, quality of life, patterns of disease progression, and changes in molecular biomarkers.\\\",\\\"detailedDescription\\\":\\\"This is a multicenter, open-label, parallel-group, randomized controlled phase III trial evaluating primary lung tumor resection in patients with EGFR-mutated oligometastatic stage IV non-small cell lung cancer treated with first-line osimertinib.\\\\n\\\\nThe study includes two eligibility assessments. During the first assessment, participants must have histologically or cytologically confirmed stage IV non-small cell lung cancer harboring an EGFR exon 19 deletion or exon 21 L858R mutation, a dominant and potentially resectable primary lung tumor, no more than three involved organs, and no more than 10 distant metastatic lesions.\\\\n\\\\nAll enrolled participants will receive protocol-defined induction treatment with osimertinib 80 mg orally once daily for 12 weeks. After induction, participants will undergo restaging. Only participants with partial response or stable disease according to RECIST version 1.1 who remain medically and technically suitable for primary lung tumor resection will undergo randomization.\\\\n\\\\nEligible participants will be randomly assigned in a 1:1 ratio to one of two groups:\\\\n\\\\n1. Osimertinib alone; or\\\\n2. Primary lung tumor resection followed by continued osimertinib. Randomization will be stratified by EGFR mutation subtype, presence of brain metastases, and number of distant metastatic lesions.\\\\n\\\\nParticipants assigned to the surgical group will undergo therapeutic resection of the primary lung tumor after randomization. The surgical approach and extent of resection will be selected by the treating thoracic surgeon according to accepted standards of care. Osimertinib will generally be resumed 1 to 2 weeks after surgery when wound healing is considered adequate. Participants in both groups will continue osimertinib until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation.\\\\n\\\\nTumor assessments will be performed approximately every 12 weeks and evaluated according to RECIST version 1.1. Local treatment of distant metastatic lesions may be provided when clinically indicated according to standard of care and institutional practice for the PTR group, as permitted by the protocol.\\\\n\\\\nThe primary objective is to compare progression-free survival between the two treatment groups. Secondary and exploratory objectives include overall survival, treatment-related adverse events, pathologic response of the primary tumor, quality of life, local-regional progression-free survival, distant metastasis progression-free survival, brain metastasis progression-free survival, polymetastatic progression-free survival, systemic therapy-free survival, and exploratory molecular biomarker outcomes.\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Lung Neoplasms, Non-Small Cell Lung Cancer\\\"],\\\"keywords\\\":[\\\"non-small cell lung cancer (NSCLC)\\\",\\\"EGFR mutation\\\",\\\"stage IV non-small-cell lung cancer\\\",\\\"Osimertinib\\\",\\\"Primary tumor resection\\\",\\\"Oligometastatic non-small cell lung cancer\\\",\\\"Local consolidative therapy\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"interventionModelDescription\\\":\\\"All participants will receive 12 weeks of first-line osimertinib induction therapy before randomization. Participants with partial response or stable disease who remain eligible for surgery will be randomized in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib.\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"NONE\\\",\\\"maskingDescription\\\":\\\"Because one treatment group undergoes surgery, participants and treating investigators will be aware of treatment assignment.\\\"}},\\\"enrollmentInfo\\\":{\\\"count\\\":154,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Osimertinib Alone\\\",\\\"type\\\":\\\"ACTIVE_COMPARATOR\\\",\\\"description\\\":\\\"Participants will receive osimertinib 80 mg orally once daily for 12 weeks before randomization. After randomization, participants assigned to this arm will continue osimertinib 80 mg once daily until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation.\\\",\\\"interventionNames\\\":[\\\"Drug: Osimertinib\\\"]},{\\\"label\\\":\\\"Osimertinib Plus Primary Tumor Resection\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participants will receive osimertinib 80 mg orally once daily for 12 weeks before randomization. After randomization, participants assigned to this arm will undergo therapeutic resection of the primary lung tumor. Osimertinib will generally be resumed 1 to 2 weeks after surgery when wound healing is considered adequate and will be continued until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation.\\\",\\\"interventionNames\\\":[\\\"Procedure: Primary Tumor Resection\\\",\\\"Drug: Osimertinib\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"PROCEDURE\\\",\\\"name\\\":\\\"Primary Tumor Resection\\\",\\\"description\\\":\\\"Participants assigned to the experimental arm will undergo therapeutic resection of the primary lung tumor after randomization. Acceptable procedures include lobectomy, sleeve lobectomy, bilobectomy, segmentectomy, and wedge resection. The surgical approach may include video-assisted thoracic surgery or thoracotomy. Pneumonectomy and sleeve pneumonectomy are not permitted. The procedure is intended to achieve maximal regional disease control and tumor-free resection margins whenever feasible.\\\",\\\"armGroupLabels\\\":[\\\"Osimertinib Plus Primary Tumor Resection\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Osimertinib\\\",\\\"description\\\":\\\"Osimertinib will be administered orally at a dose of 80 mg once daily as first-line systemic therapy. Treatment will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or fulfillment of other protocol-defined discontinuation criteria. Dose interruption or reduction will be permitted for treatment-related adverse events according to the study protocol.\\\",\\\"armGroupLabels\\\":[\\\"Osimertinib Alone\\\",\\\"Osimertinib Plus Primary Tumor Resection\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Progression-Free Survival\\\",\\\"description\\\":\\\"Progression-free survival is defined as the time from randomization to the first documented occurrence of disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"From randomization to disease progression or death, assessed up to 24 months after randomization.\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Overall Survival\\\",\\\"description\\\":\\\"Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the end of follow-up will be censored at the date they were last known to be alive.\\\",\\\"timeFrame\\\":\\\"From randomization to death from any cause, assessed up to 48 months after randomization.\\\"},{\\\"measure\\\":\\\"Number of Participants With Treatment-Related Adverse Events\\\",\\\"description\\\":\\\"Treatment-related adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The number and proportion of participants experiencing treatment-related adverse events will be summarized by treatment group.\\\",\\\"timeFrame\\\":\\\"From the first dose of osimertinib through 28 days after the last dose\\\"},{\\\"measure\\\":\\\"Pathologic Response of the Primary Lung Tumor\\\",\\\"description\\\":\\\"Percentage of residual viable tumor cells in the resected primary lung tumor. Major pathologic response is defined as ≤10% residual viable tumor, and pathologic complete response as no residual viable tumor. This outcome will be assessed only in the surgical arm.\\\",\\\"timeFrame\\\":\\\"At primary lung tumor resection, generally within 12 weeks after randomization\\\"},{\\\"measure\\\":\\\"Change From Baseline in Quality-of-Life Score\\\",\\\"description\\\":\\\"Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, version 3.0 (EORTC QLQ-C30 v3.0), together with the lung cancer-specific module (EORTC QLQ-LC13). Scores for each scale and single-item measure are linearly transformed to a 0-100 scale. Higher scores on the QLQ-C30 Global Health Status/Quality of Life and functional scales indicate better quality of life or functioning, whereas higher scores on the QLQ-C30 symptom scales and QLQ-LC13 symptom scales or items indicate greater symptom burden. No combined total score will be calculated.\\\",\\\"timeFrame\\\":\\\"Before osimertinib induction, at week 12 before randomization, and at 12 and 24 months after randomization.\\\"}],\\\"otherOutcomes\\\":[{\\\"measure\\\":\\\"Local-Regional Progression-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to the first occurrence of progression in the primary lung tumor, ipsilateral thorax, regional lymph nodes, or pleura, or death from any cause, whichever occurs first. Participants without an event will be censored at their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"From randomization until locoregional progression or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Distant Metastasis Progression-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to the first occurrence of distant progression, a new distant metastatic lesion, or death from any cause, whichever occurs first. Participants without an event will be censored at their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"Time Frame: From randomization until distant progression or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Brain Metastasis Progression-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to the first occurrence of intracranial progression, a new brain metastasis, or death from any cause, whichever occurs first. Participants without an event will be censored at their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"From randomization until intracranial progression or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Polymetastatic Progression-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to the first radiographic documentation of more than 10 distant metastatic lesions or death from any cause, whichever occurs first. Participants without an event will be censored at their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"From randomization until polymetastatic progression or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Start-or-Switch of Systemic Therapy-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to initiation of a new systemic anticancer therapy, switching from the protocol-specified regimen to another systemic regimen, adding a new systemic anticancer agent because of disease progression, or death from any cause, whichever occurs first. Dose interruption, dose reduction, dose re-escalation, or postoperative resumption of protocol-specified osimertinib will not be considered events.\\\",\\\"timeFrame\\\":\\\"From randomization until systemic therapy initiation, treatment switch, or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Plasma EGFR-Mutant Circulating Tumor DNA Variant Allele Frequency\\\",\\\"description\\\":\\\"Plasma circulating tumor DNA will be measured using next-generation sequencing. The variant allele frequency of the tumor-specific EGFR mutation will be expressed as a percentage. Change from baseline will be calculated as the variant allele frequency at each postbaseline assessment minus the baseline variant allele frequency and reported in percentage points.\\\",\\\"timeFrame\\\":\\\"Baseline before the first dose of osimertinib, Week 12, and Months 6, 12, 18, and 24\\\"},{\\\"measure\\\":\\\"Serum Carcinoembryonic Antigen Concentration\\\",\\\"description\\\":\\\"Serum carcinoembryonic antigen concentration will be measured using a clinical laboratory immunoassay and expressed in nanograms per milliliter (ng/mL).\\\",\\\"timeFrame\\\":\\\"Baseline before the first dose of osimertinib, Week 12, and Months 6, 12, 18, and 24\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"This study consists of 2 screening phases:\\\\n\\\\nPart 1 screening (before osimertinib induction):\\\\n\\\\nPatients must meet the baseline eligibility criteria, including stage IV NSCLC, EGFR sensitizing mutation (exon 19 deletion or L858R), resectable dominant primary lung lesion, and adequate performance status and organ function.\\\\n\\\\nPart 2 screening (after 12 weeks of protocol-defined osimertinib induction and before randomization):\\\\n\\\\nPatients must complete 12 weeks of osimertinib 80 mg once daily and undergo restaging evaluation. Only patients with partial response (PR) or stable disease (SD) by RECIST 1.1, and who remain suitable for thoracic surgery, will proceed to randomization.\\\\n\\\\nDisease distribution must satisfy all of the following: no more than 3 involved organs, one dominant pulmonary primary lesion, the maximal diameter of the dominant primary lung lesion greater than any individual distant metastatic lesion, and a total number of distant metastatic lesions fewer or equal than 10. Pleural or peritoneal metastasis confined to a single cavity and amenable to treatment may be considered a single metastatic lesion.\\\\n\\\\nInclusion criteria for screening part 1\\\\n\\\\n1. Histologically or cytologically confirmed NSCLC.\\\\n2. Age ≥18 years.\\\\n3. AJCC 8th edition stage IV NSCLC.\\\\n4. EGFR sensitizing mutation limited to exon 19 deletion or exon 21 L858R.\\\\n5. WHO performance status 0-1. Patients with brain metastases must be conscious; patients with bone metastases must not have irreversible severe events such as severe pathological fracture.\\\\n6. The primary lung tumor is considered resectable by the investigator and thoracic surgeon, with surgery intended for maximal regional control.\\\\n7. The patient is able to take oral medication and is expected to receive first-line osimertinib induction therapy.\\\\n8. Major organ function and pulmonary reserve are adequate to tolerate the planned surgery.\\\\n\\\\nInclusion Criteria for Screening Part 2\\\\n\\\\nSubjects may proceed to randomization only if all of the following criteria are met:\\\\n\\\\n1. The subject has received first-line protocol-defined osimertinib induction according to the study protocol, consisting of osimertinib once daily (QD) for 12 weeks, and has completed the pre-randomization evaluation.\\\\n2. Restaging imaging has been completed after 12 weeks of induction therapy, and the response is assessed as partial response (PR) or stable disease (SD) according to RECIST version 1.1. In addition, the maximal diameter of the target primary lung tumor before surgery must be greater than the sum of the maximal diameters of the metastatic tumors. PET-CT before surgery or before randomization is recommended to evaluate for newly developed extrathoracic metastases, bone metastases, or mediastinal lymph node involvement. If PET-CT is not performed, the preoperative or pre-randomization imaging assessment should include contrast-enhanced CT scans of the chest and abdomen, including the liver and adrenal glands; brain imaging should be completed with contrast-enhanced CT or MRI. Pleural or peritoneal metastasis confined to a single cavity (for example, unilateral pleural disease) and amenable to treatment may be considered a single metastatic lesion.\\\\n3. Disease distribution after induction therapy meeting all of the following criteria:\\\\n\\\\n   1. no more than 3 involved organs;\\\\n   2. one dominant pulmonary primary lesion;\\\\n   3. the maximal diameter of the dominant pulmonary primary lesion is greater than any single distant metastatic lesion;\\\\n   4. total number of distant metastatic lesions fewer or equal to 10.\\\\n4. After 12 weeks of protocol-defined osimertinib induction, the patient must have PR or SD by RECIST 1.1 and remain eligible for randomization.\\\\n\\\\n   If either of the following conditions is present on restaging imaging:\\\\n   1. Poor primary tumor response: the sum of the longest diameters (SLD) of the primary lung tumor after treatment falls within the range of less than 30% decrease and less than 20% increase (that is, -30% \\\\\\\\\\u003c SLD change \\\\\\\\\\u003c +20%); or\\\\n   2. Polymetastatic condition: the total number of distant metastatic lesions is 6 to 10,\\\\n\\\\n   then the treatment response of the other distant target metastatic lesions must additionally meet an SLD reduction of at least 30% in order for the subject to remain eligible for randomization.\\\\n5. Estimated life expectancy is greater than 3 months, as judged by the investigator.\\\\n6. The subject remains suitable for primary lung tumor resection, as assessed by the investigator and thoracic surgeon, and has no major comorbidity that would increase surgical risk to an unacceptable level.\\\\n\\\\nExclusion criteria Subjects meeting any of the following criteria will be excluded from this study. If any of these conditions are identified only after completion of the 12-week induction phase, the subject will not proceed to randomization.\\\\n\\\\n1. Pathology other than non-small cell lung cancer (NSCLC), or failure to meet the EGFR mutation criteria specified in this study.\\\\n2. EGFR mutation other than exon 19 deletion or exon 21 L858R.\\\\n3. Involvement of more than 3 organs by tumor lesions at post-induction restaging, before randomization.\\\\n4. Total number of distant metastatic lesions greater than 10 at post-induction restaging, before randomization.\\\\n5. No clearly dominant primary pulmonary lesion, or the maximal diameter of the dominant primary pulmonary lesion is not greater than any individual distant metastatic lesion at post-induction restaging, before randomization\\\\n6. Diffuse pleural or peritoneal carcinomatosis that cannot be clearly localized and treated with local definitive therapy.\\\\n7. Progressive disease (PD) on imaging evaluation after 12 weeks of protocol-defined osimertinib induction.\\\\n8. Judged by the investigator or thoracic surgeon to be no longer suitable for thoracic surgery after induction therapy.\\\\n9. Any systemic therapy other than the protocol-defined osimertinib induction for the current stage IV NSCLC.\\\\n10. Any prior EGFR-TKI, chemotherapy, immunotherapy, or other systemic anticancer therapy for the current stage IV NSCLC, except for the protocol-defined osimertinib induction.\\\\n11. Pregnant, breastfeeding, or planning pregnancy during the study period.\\\\n12. Any condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study, or highly likely to be unable to comply with the study procedures, restrictions, or requirements.\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"ALL\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"Chong-Jen Yu, MD\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"+886-2-2322-0322\\\",\\\"email\\\":\\\"jefferycjyu@ntu.edu.tw\\\"}],\\\"overallOfficials\\\":[{\\\"name\\\":\\\"Chong-Jen Yu, MD\\\",\\\"affiliation\\\":\\\"National Taiwan University Hospital\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"National Taiwan University Hospital\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Taipei\\\",\\\"state\\\":\\\"Taipei City\\\",\\\"zip\\\":\\\"100\\\",\\\"country\\\":\\\"Taiwan\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Dobbie Pei-Hsing Chen, MD\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"+886-2-2322-0322\\\",\\\"email\\\":\\\"chenph@ntu.edu.tw\\\"},{\\\"name\\\":\\\"Chong-Jen Yu, MD\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"},{\\\"name\\\":\\\"Jin-Shing Chen, MD,PhD\\\",\\\"role\\\":\\\"SUB_INVESTIGATOR\\\"},{\\\"name\\\":\\\"Dobbie Pei-Hsing Chen, MD\\\",\\\"role\\\":\\\"SUB_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":25.05306,\\\"lon\\\":121.52639}}]},\\\"ipdSharingStatementModule\\\":{\\\"ipdSharing\\\":\\\"UNDECIDED\\\",\\\"description\\\":\\\"The individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant-level data will be subject to applicable ethical approvals, institutional policies, data-use agreements, and protection of participant confidentiality.\\\"}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D008175\\\",\\\"term\\\":\\\"Lung Neoplasms\\\"},{\\\"id\\\":\\\"D002289\\\",\\\"term\\\":\\\"Carcinoma, Non-Small-Cell Lung\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D012142\\\",\\\"term\\\":\\\"Respiratory Tract Neoplasms\\\"},{\\\"id\\\":\\\"D013899\\\",\\\"term\\\":\\\"Thoracic Neoplasms\\\"},{\\\"id\\\":\\\"D009371\\\",\\\"term\\\":\\\"Neoplasms by Site\\\"},{\\\"id\\\":\\\"D009369\\\",\\\"term\\\":\\\"Neoplasms\\\"},{\\\"id\\\":\\\"D008171\\\",\\\"term\\\":\\\"Lung Diseases\\\"},{\\\"id\\\":\\\"D012140\\\",\\\"term\\\":\\\"Respiratory Tract Diseases\\\"},{\\\"id\\\":\\\"D002283\\\",\\\"term\\\":\\\"Carcinoma, Bronchogenic\\\"},{\\\"id\\\":\\\"D001984\\\",\\\"term\\\":\\\"Bronchial Neoplasms\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"C000596361\\\",\\\"term\\\":\\\"osimertinib\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07640789\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"BL-B01D1-318\\\"},\\\"organization\\\":{\\\"fullName\\\":\\\"Sichuan Baili Pharmaceutical Co., Ltd.\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)\\\",\\\"officialTitle\\\":\\\"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-09\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-08-28\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2030-12\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2030-12\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-06-07\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-06-07\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-06-11\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-09-08\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-09-10\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"Sichuan Baili Pharmaceutical Co., Ltd.\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"collaborators\\\":[{\\\"name\\\":\\\"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.\\\",\\\"class\\\":\\\"INDUSTRY\\\"}]},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":false,\\\"isFdaRegulatedDevice\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.\\\",\\\"detailedDescription\\\":\\\"In this trial, the treatment group receives BL-B01D1 in combination with osimertinib, while the control group receives osimertinib monotherapy.\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Non-small Cell Lung Cancer Stage III\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"NONE\\\"}},\\\"enrollmentInfo\\\":{\\\"count\\\":418,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"BL-B01D1+Osimertinib\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participants receive BL-B01D1+Osimertinib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.\\\",\\\"interventionNames\\\":[\\\"Drug: BL-B01D1\\\",\\\"Drug: Osimertinib\\\"]},{\\\"label\\\":\\\"Osimertinib\\\",\\\"type\\\":\\\"ACTIVE_COMPARATOR\\\",\\\"description\\\":\\\"Participants receive Osimertinib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.\\\",\\\"interventionNames\\\":[\\\"Drug: Osimertinib\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"BL-B01D1\\\",\\\"description\\\":\\\"Administration by intravenous infusion for a cycle of 3 weeks.\\\",\\\"armGroupLabels\\\":[\\\"BL-B01D1+Osimertinib\\\"],\\\"otherNames\\\":[\\\"iza-bren\\\",\\\"izalontamab brengitecan\\\",\\\"BMS-986507\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Osimertinib\\\",\\\"description\\\":\\\"Oral administration for a cycle of 3 weeks.\\\",\\\"armGroupLabels\\\":[\\\"BL-B01D1+Osimertinib\\\",\\\"Osimertinib\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Progression-free survival (PFS)\\\",\\\"description\\\":\\\"Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Overall Survival (OS)\\\",\\\"description\\\":\\\"Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Objective Response Rate (ORR)\\\",\\\"description\\\":\\\"Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Disease Control Rate (DCR)\\\",\\\"description\\\":\\\"Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Duration of Response (DOR)\\\",\\\"description\\\":\\\"Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Treatment Emergent Adverse Event (TEAE)\\\",\\\"description\\\":\\\"TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Anti-drug antibody (ADA)\\\",\\\"description\\\":\\\"Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Inclusion Criteria:\\\\n\\\\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\\\\n2. Age ≥ 18 years and ≤ 75 years, regardless of gender;\\\\n3. Expected survival time ≥ 3 months;\\\\n4. Unresectable Stage III non-small cell lung cancer;\\\\n5. Detection of one of the EGFR-sensitive mutation types in tumor tissue;\\\\n6. Agree to provide archived primary tumor tissue specimens or fresh tissue samples within 1 year;\\\\n7. In platinum-based radical chemoradiotherapy, the platinum-containing chemotherapy regimen must include one of the specified drugs in addition to the platinum agent;\\\\n8. In platinum-based radical chemoradiotherapy, patients must have received a total radiation dose of 60 Gy ± 10% before randomization;\\\\n9. Toxicities from prior chemoradiotherapy must have resolved to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\\\\n10. ECOG performance status score of 0 or 1;\\\\n11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\\\\n12. Organ function levels must meet the requirements;\\\\n13. Urine protein ≤ 1+ or \\\\\\\\\\u003c 1000 mg/24h;\\\\n14. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the test must rule out pregnancy; they must not be lactating; all enrolled trial participants must take adequate barrier contraceptive measures throughout the treatment period and for 7 months after treatment ends.\\\\n\\\\nExclusion Criteria:\\\\n\\\\n1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;\\\\n2. The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy;\\\\n3. Major surgery within 4 weeks prior to the first dose;\\\\n4. Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies/ADCs targeting EGFR and/or HER3;\\\\n5. History of severe heart disease or cerebrovascular disease;\\\\n6. Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\\\\n7. Any thrombotic events such as deep vein thrombosis, arterial thrombosis, or pulmonary embolism within 6 months prior to screening;\\\\n8. Diagnosis of active malignancy within 5 years prior to study randomization;\\\\n9. Hypertension poorly controlled by two antihypertensive medications;\\\\n10. Trial participants with poorly controlled blood glucose levels;\\\\n11. Current radiation pneumonitis of Grade ≥2 as defined by CTCAE;\\\\n12. Concurrent lung disease resulting in clinically severe respiratory impairment;\\\\n13. Severe infection within 4 weeks prior to study randomization;\\\\n14. Large serous cavity effusions or symptomatic serous cavity effusions;\\\\n15. Imaging findings suggesting tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;\\\\n16. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;\\\\n17. Trial participants with clinically significant bleeding or a clear tendency for bleeding within 4 weeks prior to signing informed consent;\\\\n18. Trial participants with a history of inflammatory bowel disease, extensive bowel resection, or immune-mediated enteritis;\\\\n19. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug;\\\\n20. History of autologous or allogeneic stem cell transplantation;\\\\n21. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;\\\\n22. History of severe neurological or psychiatric disorders, or a history of substance abuse, alcoholism, or drug addiction;\\\\n23. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;\\\\n24. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other reasons.\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"ALL\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"maximumAge\\\":\\\"75 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"Sa Xiao, PHD\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"15013238943\\\",\\\"email\\\":\\\"xiaosa@baili-pharm.com\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"Cancer Hospital of Shandong First Medical University\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Jinan\\\",\\\"state\\\":\\\"Shandong\\\",\\\"country\\\":\\\"China\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Jinming Yu\\\",\\\"role\\\":\\\"CONTACT\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":36.66833,\\\"lon\\\":116.99722}}]}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D002289\\\",\\\"term\\\":\\\"Carcinoma, Non-Small-Cell Lung\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D002283\\\",\\\"term\\\":\\\"Carcinoma, Bronchogenic\\\"},{\\\"id\\\":\\\"D001984\\\",\\\"term\\\":\\\"Bronchial Neoplasms\\\"},{\\\"id\\\":\\\"D008175\\\",\\\"term\\\":\\\"Lung Neoplasms\\\"},{\\\"id\\\":\\\"D012142\\\",\\\"term\\\":\\\"Respiratory Tract Neoplasms\\\"},{\\\"id\\\":\\\"D013899\\\",\\\"term\\\":\\\"Thoracic Neoplasms\\\"},{\\\"id\\\":\\\"D009371\\\",\\\"term\\\":\\\"Neoplasms by Site\\\"},{\\\"id\\\":\\\"D009369\\\",\\\"term\\\":\\\"Neoplasms\\\"},{\\\"id\\\":\\\"D008171\\\",\\\"term\\\":\\\"Lung Diseases\\\"},{\\\"id\\\":\\\"D012140\\\",\\\"term\\\":\\\"Respiratory Tract Diseases\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"C000596361\\\",\\\"term\\\":\\\"osimertinib\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07686081\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"VP-VSP-128-3201\\\"},\\\"organization\\\":{\\\"fullName\\\":\\\"Vanda Pharmaceuticals\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis\\\",\\\"officialTitle\\\":\\\"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ponesimod in Patients With Moderately to Severely Active Ulcerative Colitis\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-08\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-09\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2029-04\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2029-08\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-06-30\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-06-30\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-07-07\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-08-14\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-08-18\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"Vanda Pharmaceuticals\\\",\\\"class\\\":\\\"INDUSTRY\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":true,\\\"isFdaRegulatedDevice\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active ulcerative colitis\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Ulcerative Colitis (UC)\\\"],\\\"keywords\\\":[\\\"ulcerative colitis\\\",\\\"moderately to severely active ulcerative colitis\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"QUADRUPLE\\\",\\\"whoMasked\\\":[\\\"PARTICIPANT\\\",\\\"CARE_PROVIDER\\\",\\\"INVESTIGATOR\\\",\\\"OUTCOMES_ASSESSOR\\\"]}},\\\"enrollmentInfo\\\":{\\\"count\\\":150,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Ponesimod (VSP-128)\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"interventionNames\\\":[\\\"Drug: Ponesimod\\\"]},{\\\"label\\\":\\\"Placebo\\\",\\\"type\\\":\\\"PLACEBO_COMPARATOR\\\",\\\"interventionNames\\\":[\\\"Drug: Placebo\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Ponesimod\\\",\\\"description\\\":\\\"Ponesimod administered orally once daily. Participants are randomized 2:1 to Ponesimod or placebo during a 16-week double-blind period. A 14-day titration is followed by a stable dose daily from Day 15 through end of treatment. Participants may enter a 36-week open-label extension receiving Ponesimod.\\\",\\\"armGroupLabels\\\":[\\\"Ponesimod (VSP-128)\\\"],\\\"otherNames\\\":[\\\"VSP-128\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Placebo\\\",\\\"description\\\":\\\"Matching placebo administered orally once daily during a 16-week double-blind period (2:1 randomization). A mock 14-day titration is used to maintain blinding. Participants may enter a 36-week open-label extension receiving Ponesimod.\\\",\\\"armGroupLabels\\\":[\\\"Placebo\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Clinical Remission at Week 16\\\",\\\"description\\\":\\\"Proportion of participants achieving clinical remission at Week 16.\\\",\\\"timeFrame\\\":\\\"Week 16\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Clinical Response at Week 16\\\",\\\"description\\\":\\\"Proportion of participants achieving clinical response at Week 16.\\\",\\\"timeFrame\\\":\\\"Week 16\\\"},{\\\"measure\\\":\\\"Change From Baseline in Mayo Score at Week 16\\\",\\\"description\\\":\\\"Change from baseline in the three-component Mayo Score at Week 16. The overall score value ranges from 0 to 9, with higher scores indicating more severe ulcerative colitis disease activity.\\\",\\\"timeFrame\\\":\\\"Baseline to Week 16.\\\"},{\\\"measure\\\":\\\"Endoscopic Improvement at Week 16\\\",\\\"description\\\":\\\"Proportion of participants achieving endoscopic improvement at Week 16.\\\",\\\"timeFrame\\\":\\\"Week 16\\\"},{\\\"measure\\\":\\\"Symptomatic Remission at Week 16\\\",\\\"description\\\":\\\"Proportion of participants achieving symptomatic remission at Week 16.\\\",\\\"timeFrame\\\":\\\"Week 16\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Inclusion Criteria:\\\\n\\\\n* Male and female subjects aged 18-75 years\\\\n* Able to provide written informed consent\\\\n* Diagnosis of ulcerative colitis for ≥90 days prior to screening\\\\n* Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1\\\\n* History of inadequate response, loss of response, or intolerance to at least one approved UC therapy\\\\n\\\\nExclusion Criteria:\\\\n\\\\n* Severe or fulminant UC likely to require hospitalization or surgery\\\\n* Diagnosis of Crohn's disease or other non-UC colitis\\\\n* Prior exposure to S1P receptor modulators\\\\n* Active or chronic infections\\\\n* Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease\\\\n* History of an allergic reaction or significant sensitivity to constituents of study drug\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"ALL\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"maximumAge\\\":\\\"75 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"Vanda Pharmaceuticals Inc.\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"202-734-3400\\\",\\\"email\\\":\\\"clinicaltrials@vandapharma.com\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"Vanda Investigational Site\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Chula Vista\\\",\\\"state\\\":\\\"California\\\",\\\"zip\\\":\\\"91910\\\",\\\"country\\\":\\\"United States\\\",\\\"geoPoint\\\":{\\\"lat\\\":32.64005,\\\"lon\\\":-117.0842}},{\\\"facility\\\":\\\"Vanda Investigational Site\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Nashville\\\",\\\"state\\\":\\\"Tennessee\\\",\\\"zip\\\":\\\"37211\\\",\\\"country\\\":\\\"United States\\\",\\\"geoPoint\\\":{\\\"lat\\\":36.16589,\\\"lon\\\":-86.78444}}]},\\\"ipdSharingStatementModule\\\":{\\\"ipdSharing\\\":\\\"NO\\\"}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D003093\\\",\\\"term\\\":\\\"Colitis, Ulcerative\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D003092\\\",\\\"term\\\":\\\"Colitis\\\"},{\\\"id\\\":\\\"D005759\\\",\\\"term\\\":\\\"Gastroenteritis\\\"},{\\\"id\\\":\\\"D005767\\\",\\\"term\\\":\\\"Gastrointestinal Diseases\\\"},{\\\"id\\\":\\\"D004066\\\",\\\"term\\\":\\\"Digestive System Diseases\\\"},{\\\"id\\\":\\\"D015212\\\",\\\"term\\\":\\\"Inflammatory Bowel Diseases\\\"},{\\\"id\\\":\\\"D003108\\\",\\\"term\\\":\\\"Colonic Diseases\\\"},{\\\"id\\\":\\\"D007410\\\",\\\"term\\\":\\\"Intestinal Diseases\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"C550169\\\",\\\"term\\\":\\\"ponesimod\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07564141\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"GCT1184-07\\\"},\\\"secondaryIdInfos\\\":[{\\\"id\\\":\\\"2025-524202-15-00\\\",\\\"type\\\":\\\"CTIS\\\"},{\\\"id\\\":\\\"jRCT2021260025\\\",\\\"type\\\":\\\"REGISTRY\\\",\\\"domain\\\":\\\"Japan Registry for Clinical Trials (jRCT)\\\"},{\\\"id\\\":\\\"GOG-3143\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"ENGOT-ov103\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"GEICO-177-O\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"APGOT-ov21\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"LACOG 0126-EVA\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"2025\\\",\\\"type\\\":\\\"NIH\\\",\\\"link\\\":\\\"https://reporter.nih.gov/quickSearch/2025\\\"}],\\\"organization\\\":{\\\"fullName\\\":\\\"Genmab\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer\\\",\\\"officialTitle\\\":\\\"A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer\\\",\\\"acronym\\\":\\\"RAINFOL™-07\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-08\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-08-28\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2029-12\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2031-11\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-04-27\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-04-27\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-05-04\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-08-31\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-09-01\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"Genmab\\\",\\\"class\\\":\\\"INDUSTRY\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":true,\\\"isFdaRegulatedDevice\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.\\\\n\\\\nThe purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.\\\\n\\\\nParticipants will receive either:\\\\n\\\\n* Rina-S monotherapy (by itself),\\\\n* Rina-S plus bevacizumab,\\\\n* investigator's choice chemotherapy (by itself) (standard of care), or\\\\n* investigator's choice chemotherapy plus bevacizumab (standard of care).\\\\n\\\\nNo participants will be given placebo. Participants will participate in 1 of 2 arms.\\\\n\\\\nThe treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.\\\\n\\\\nParticipants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.\\\\n\\\\nThe overall study duration (including screening, treatment, and follow-up) will be different for every participant.\\\",\\\"detailedDescription\\\":\\\"This is a global, open-label, randomized, Phase 3 study of Rina-S ± bevacizumab versus investigator's choice (IC) ± bevacizumab as second-line (2L) treatment in participants with recurrent platinum-sensitive ovarian cancer (PSOC).\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Platinum-Sensitive Ovarian Cancer\\\",\\\"Ovarian Cancer\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"NONE\\\"}},\\\"enrollmentInfo\\\":{\\\"count\\\":688,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Arm 1: Rina-S ± Bevacizumab\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).\\\",\\\"interventionNames\\\":[\\\"Biological: Rina-S\\\",\\\"Drug: Bevacizumab\\\"]},{\\\"label\\\":\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\",\\\"type\\\":\\\"ACTIVE_COMPARATOR\\\",\\\"description\\\":\\\"Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.\\\",\\\"interventionNames\\\":[\\\"Drug: Bevacizumab\\\",\\\"Drug: Carboplatin\\\",\\\"Drug: Gemcitabine\\\",\\\"Drug: Paclitaxel\\\",\\\"Drug: PLD\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"BIOLOGICAL\\\",\\\"name\\\":\\\"Rina-S\\\",\\\"description\\\":\\\"Intravenous (IV) infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 1: Rina-S ± Bevacizumab\\\"],\\\"otherNames\\\":[\\\"Rinatabart Sesutecan\\\",\\\"GEN1184\\\",\\\"PRO1184\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Bevacizumab\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 1: Rina-S ± Bevacizumab\\\",\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Carboplatin\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Gemcitabine\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Paclitaxel\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"PLD\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Overall Survival (OS)\\\",\\\"timeFrame\\\":\\\"Up to approximately 5 years\\\"},{\\\"measure\\\":\\\"PFS per RECIST v1.1, as Determined by Investigator\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Objective Response Rate (ORR) per RECIST v1.1\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Duration of Response (DOR) per RECIST v1.1\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Time to First Subsequent Therapy (TFST)\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Number of Participants with Treatment-emergent Adverse Events (TEAEs)\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)\\\",\\\"timeFrame\\\":\\\"Baseline up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Key Inclusion Criteria:\\\\n\\\\n* Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.\\\\n* Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, \\\\\\\\\\u003e183 days) after their last dose administration of platinum-based therapy.\\\\n* Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.\\\\n* Participants must have measurable disease per RECIST v1.1 by investigator at baseline.\\\\n* All participants must provide a tumor specimen.\\\\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.\\\\n\\\\nKey Exclusion Criteria:\\\\n\\\\n* Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.\\\\n* Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.\\\\n* Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.\\\\n* Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).\\\\n\\\\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"FEMALE\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"Genmab Trial Information\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"+4570202728\\\",\\\"email\\\":\\\"clinicaltrials@genmab.com\\\"}],\\\"overallOfficials\\\":[{\\\"name\\\":\\\"Study Official\\\",\\\"affiliation\\\":\\\"Genmab\\\",\\\"role\\\":\\\"STUDY_DIRECTOR\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"Danbury Hospital\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Danbury\\\",\\\"state\\\":\\\"Connecticut\\\",\\\"zip\\\":\\\"06810\\\",\\\"country\\\":\\\"United States\\\",\\\"geoPoint\\\":{\\\"lat\\\":41.39482,\\\"lon\\\":-73.45401}},{\\\"facility\\\":\\\"ProHealth Care Inc\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Waukesha\\\",\\\"state\\\":\\\"Wisconsin\\\",\\\"zip\\\":\\\"53188\\\",\\\"country\\\":\\\"United States\\\",\\\"geoPoint\\\":{\\\"lat\\\":43.01168,\\\"lon\\\":-88.23148}}]},\\\"ipdSharingStatementModule\\\":{\\\"ipdSharing\\\":\\\"NO\\\"}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D010051\\\",\\\"term\\\":\\\"Ovarian Neoplasms\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D004701\\\",\\\"term\\\":\\\"Endocrine Gland Neoplasms\\\"},{\\\"id\\\":\\\"D009371\\\",\\\"term\\\":\\\"Neoplasms by Site\\\"},{\\\"id\\\":\\\"D009369\\\",\\\"term\\\":\\\"Neoplasms\\\"},{\\\"id\\\":\\\"D010049\\\",\\\"term\\\":\\\"Ovarian Diseases\\\"},{\\\"id\\\":\\\"D000291\\\",\\\"term\\\":\\\"Adnexal Diseases\\\"},{\\\"id\\\":\\\"D005831\\\",\\\"term\\\":\\\"Genital Diseases, Female\\\"},{\\\"id\\\":\\\"D052776\\\",\\\"term\\\":\\\"Female Urogenital Diseases\\\"},{\\\"id\\\":\\\"D005261\\\",\\\"term\\\":\\\"Female Urogenital Diseases and Pregnancy Complications\\\"},{\\\"id\\\":\\\"D000091642\\\",\\\"term\\\":\\\"Urogenital Diseases\\\"},{\\\"id\\\":\\\"D005833\\\",\\\"term\\\":\\\"Genital Neoplasms, Female\\\"},{\\\"id\\\":\\\"D014565\\\",\\\"term\\\":\\\"Urogenital Neoplasms\\\"},{\\\"id\\\":\\\"D000091662\\\",\\\"term\\\":\\\"Genital Diseases\\\"},{\\\"id\\\":\\\"D004700\\\",\\\"term\\\":\\\"Endocrine System Diseases\\\"},{\\\"id\\\":\\\"D006058\\\",\\\"term\\\":\\\"Gonadal Disorders\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D000068258\\\",\\\"term\\\":\\\"Bevacizumab\\\"},{\\\"id\\\":\\\"D016190\\\",\\\"term\\\":\\\"Carboplatin\\\"},{\\\"id\\\":\\\"D000093542\\\",\\\"term\\\":\\\"Gemcitabine\\\"},{\\\"id\\\":\\\"D017239\\\",\\\"term\\\":\\\"Paclitaxel\\\"},{\\\"id\\\":\\\"C041277\\\",\\\"term\\\":\\\"1-dodecylpyridoxal\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D061067\\\",\\\"term\\\":\\\"Antibodies, Monoclonal, Humanized\\\"},{\\\"id\\\":\\\"D000911\\\",\\\"term\\\":\\\"Antibodies, Monoclonal\\\"},{\\\"id\\\":\\\"D000906\\\",\\\"term\\\":\\\"Antibodies\\\"},{\\\"id\\\":\\\"D007136\\\",\\\"term\\\":\\\"Immunoglobulins\\\"},{\\\"id\\\":\\\"D007162\\\",\\\"term\\\":\\\"Immunoproteins\\\"},{\\\"id\\\":\\\"D001798\\\",\\\"term\\\":\\\"Blood Proteins\\\"},{\\\"id\\\":\\\"D011506\\\",\\\"term\\\":\\\"Proteins\\\"},{\\\"id\\\":\\\"D000602\\\",\\\"term\\\":\\\"Amino Acids, Peptides, and Proteins\\\"},{\\\"id\\\":\\\"D012712\\\",\\\"term\\\":\\\"Serum Globulins\\\"},{\\\"id\\\":\\\"D005916\\\",\\\"term\\\":\\\"Globulins\\\"},{\\\"id\\\":\\\"D056831\\\",\\\"term\\\":\\\"Coordination Complexes\\\"},{\\\"id\\\":\\\"D009930\\\",\\\"term\\\":\\\"Organic Chemicals\\\"},{\\\"id\\\":\\\"D006571\\\",\\\"term\\\":\\\"Heterocyclic Compounds\\\"},{\\\"id\\\":\\\"D003841\\\",\\\"term\\\":\\\"Deoxycytidine\\\"},{\\\"id\\\":\\\"D003562\\\",\\\"term\\\":\\\"Cytidine\\\"},{\\\"id\\\":\\\"D011741\\\",\\\"term\\\":\\\"Pyrimidine Nucleosides\\\"},{\\\"id\\\":\\\"D011743\\\",\\\"term\\\":\\\"Pyrimidines\\\"},{\\\"id\\\":\\\"D006573\\\",\\\"term\\\":\\\"Heterocyclic Compounds, 1-Ring\\\"},{\\\"id\\\":\\\"D043823\\\",\\\"term\\\":\\\"Taxoids\\\"},{\\\"id\\\":\\\"D043822\\\",\\\"term\\\":\\\"Cyclodecanes\\\"},{\\\"id\\\":\\\"D003516\\\",\\\"term\\\":\\\"Cycloparaffins\\\"},{\\\"id\\\":\\\"D006840\\\",\\\"term\\\":\\\"Hydrocarbons, Alicyclic\\\"},{\\\"id\\\":\\\"D006844\\\",\\\"term\\\":\\\"Hydrocarbons, Cyclic\\\"},{\\\"id\\\":\\\"D006838\\\",\\\"term\\\":\\\"Hydrocarbons\\\"},{\\\"id\\\":\\\"D004224\\\",\\\"term\\\":\\\"Diterpenes\\\"},{\\\"id\\\":\\\"D013729\\\",\\\"term\\\":\\\"Terpenes\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07804186\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"IDE196-011\\\"},\\\"organization\\\":{\\\"fullName\\\":\\\"IDEAYA Biosciences\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma\\\",\\\"officialTitle\\\":\\\"A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-08\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-09\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2034-03\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2034-04\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-08-21\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-08-31\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-09-04\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-08-31\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-09-04\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"IDEAYA Biosciences\\\",\\\"class\\\":\\\"INDUSTRY\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":true,\\\"isFdaRegulatedDevice\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)\\\",\\\"detailedDescription\\\":\\\"This study will enroll participants who are at high-risk for metastatic disease and who have completed primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation) for their UM without evidence of active local or metastatic disease after this treatment.\\\\n\\\\nThe Treatment Arm will have participants who have completed PLT and will receive darovasertib + crizotinib.\\\\n\\\\nThe Observation Arm participants will not receive darovasertib + crizotinib but will be observed and followed for disease recurrence and survival (Control Arm)\\\\n\\\\nParticipants in both arms will be followed for up to five years to assess longer term outcomes such as tumor recurrence and survival.\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Uveal Melanoma\\\"],\\\"keywords\\\":[\\\"Uveal Melanoma\\\",\\\"plaque brachytherapy\\\",\\\"enucleation\\\",\\\"proton beam\\\",\\\"Adjuvant\\\",\\\"Darovasertib\\\",\\\"IDE 196\\\",\\\"Ocular Melanoma\\\",\\\"Choroidal Melanoma\\\",\\\"Ocular Oncology\\\",\\\"Protein Kinase C\\\",\\\"GNAQ\\\",\\\"GNA11\\\",\\\"Crizotinib\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"NONE\\\"}},\\\"enrollmentInfo\\\":{\\\"count\\\":450,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Treatment\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested\\\",\\\"interventionNames\\\":[\\\"Drug: Darovasertib\\\",\\\"Drug: Crizotinib (Xalkori)\\\"]},{\\\"label\\\":\\\"Observation\\\",\\\"type\\\":\\\"NO_INTERVENTION\\\",\\\"description\\\":\\\"Participant Group/Arm: Observation Standard of care observation \\\\\\\\\\u0026 follow-up (no treatment)\\\"}],\\\"interventions\\\":[{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Darovasertib\\\",\\\"description\\\":\\\"Oral, selectively targets key proteins\\\",\\\"armGroupLabels\\\":[\\\"Treatment\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Crizotinib (Xalkori)\\\",\\\"description\\\":\\\"Oral small molecule\\\",\\\"armGroupLabels\\\":[\\\"Treatment\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Median relapse-free survival\\\",\\\"description\\\":\\\"Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Median metastasis-free survival\\\",\\\"description\\\":\\\"Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) by BICR per RECIST v 1.1\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Overall survival\\\",\\\"description\\\":\\\"Overall survival with darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease who are at high-risk for recurrence\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Median UM specific survival\\\",\\\"description\\\":\\\"Median UM specific survival defined as the time from randomization to the date of death due to UM\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Median metastasis-free survival\\\",\\\"description\\\":\\\"Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) as assessed by investigator\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Safety, and severity of occurrence of adverse events (AEs) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V6.0 or later\\\",\\\"description\\\":\\\"To assess safety and tolerability of darovasertib + crizotinib in participants who have completed PLT for primary UM\\\",\\\"timeFrame\\\":\\\"Approximately 3 years\\\"},{\\\"measure\\\":\\\"Change from baseline over time and across Treatment Arms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30)\\\",\\\"description\\\":\\\"Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Recurrence-free suvival\\\",\\\"description\\\":\\\"Compare RFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Metastasis-Free Survival\\\",\\\"description\\\":\\\"Compare MFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Median Local Recurrence-Free Survival\\\",\\\"description\\\":\\\"Compare local RFS (LRFS) of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Change from baseline over time and across Treatment Arms as measured by European Quality of Life Questionnaire EQ-5D-5L.\\\",\\\"description\\\":\\\"Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM\\\",\\\"timeFrame\\\":\\\"[Time Frame: Approximately 5 years]\\\"},{\\\"measure\\\":\\\"Change from baseline over time and across Treatment Arms as measured by EORTC Oncology Quality of Life Questionnaire Ophthalmic-30 (EORTC QLQ-OPT30)\\\",\\\"description\\\":\\\"Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM\\\",\\\"timeFrame\\\":\\\"[Time Frame: Approximately 5 years]\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Inclusion Criteria:\\\\n\\\\n* Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3)\\\\n* Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy)\\\\n* ECOG performance status of 0 or 1\\\\n* Adequate organ function\\\\n* Age 18 or older\\\\n* Written informed consent and ability to comply\\\\n* Primary local therapy completed within 120 days before C1D1/randomization.\\\\n* Contraception requirements\\\\n\\\\nExclusion Criteria:\\\\n\\\\n* Previous systemic treatment for Uveal Melanoma\\\\n* Clinical or radiological evidence of metastatic UM\\\\n* Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin cancers, any malignancy considered to be indolent and never required systemic therapy, and any type of carcinoma in situ receiving curative therapy (resection)\\\\n* Known AIDS related illness\\\\n* History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids\\\\n* History of syncope may be exclusionary, but will be reviewed on a case-by-case basis\\\\n* Active Hepatitis B or C infection\\\\n* Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow\\\\n* Females who are pregnant or breastfeeding\\\\n* Impaired cardiac function\\\\n* History of stroke within the last 6 months of randomization\\\\n* Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib\\\\n* allergy to mammalian meat products or gelatin\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"ALL\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"IDEAYA Clinical Trials\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"+1-855-433-2246\\\",\\\"email\\\":\\\"IDEAYAClinicalTrials@ideayabio.com\\\"},{\\\"name\\\":\\\"Holger Thurm\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"email\\\":\\\"hthurm@ideayabio.com\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"Princess Margaret Cancer Centre\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Toronto\\\",\\\"state\\\":\\\"Ontario\\\",\\\"zip\\\":\\\"M5G 2M9\\\",\\\"country\\\":\\\"Canada\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Marcus Butler, MD\\\",\\\"role\\\":\\\"CONTACT\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":43.70643,\\\"lon\\\":-79.39864}}]},\\\"ipdSharingStatementModule\\\":{\\\"ipdSharing\\\":\\\"NO\\\"}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D000098943\\\",\\\"term\\\":\\\"Uveal Melanoma\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D008545\\\",\\\"term\\\":\\\"Melanoma\\\"},{\\\"id\\\":\\\"D018358\\\",\\\"term\\\":\\\"Neuroendocrine Tumors\\\"},{\\\"id\\\":\\\"D017599\\\",\\\"term\\\":\\\"Neuroectodermal Tumors\\\"},{\\\"id\\\":\\\"D009373\\\",\\\"term\\\":\\\"Neoplasms, Germ Cell and Embryonal\\\"},{\\\"id\\\":\\\"D009370\\\",\\\"term\\\":\\\"Neoplasms by Histologic Type\\\"},{\\\"id\\\":\\\"D009369\\\",\\\"term\\\":\\\"Neoplasms\\\"},{\\\"id\\\":\\\"D009380\\\",\\\"term\\\":\\\"Neoplasms, Nerve Tissue\\\"},{\\\"id\\\":\\\"D018326\\\",\\\"term\\\":\\\"Nevi and Melanomas\\\"},{\\\"id\\\":\\\"D014604\\\",\\\"term\\\":\\\"Uveal Neoplasms\\\"},{\\\"id\\\":\\\"D005134\\\",\\\"term\\\":\\\"Eye Neoplasms\\\"},{\\\"id\\\":\\\"D009371\\\",\\\"term\\\":\\\"Neoplasms by Site\\\"},{\\\"id\\\":\\\"D005128\\\",\\\"term\\\":\\\"Eye Diseases\\\"},{\\\"id\\\":\\\"D014603\\\",\\\"term\\\":\\\"Uveal Diseases\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D000077547\\\",\\\"term\\\":\\\"Crizotinib\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D010880\\\",\\\"term\\\":\\\"Piperidines\\\"},{\\\"id\\\":\\\"D006573\\\",\\\"term\\\":\\\"Heterocyclic Compounds, 1-Ring\\\"},{\\\"id\\\":\\\"D006571\\\",\\\"term\\\":\\\"Heterocyclic Compounds\\\"},{\\\"id\\\":\\\"D000631\\\",\\\"term\\\":\\\"Aminopyridines\\\"},{\\\"id\\\":\\\"D011725\\\",\\\"term\\\":\\\"Pyridines\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07623161\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"TAK-226-3002\\\"},\\\"secondaryIdInfos\\\":[{\\\"id\\\":\\\"2026-525660-17-00\\\",\\\"type\\\":\\\"CTIS\\\"}],\\\"organization\\\":{\\\"fullName\\\":\\\"Takeda\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib\\\",\\\"officialTitle\\\":\\\"A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy\\\",\\\"acronym\\\":\\\"ELRISE MF\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-08\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-09-02\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2029-12-07\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2034-03-30\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-05-29\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-05-29\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-06-03\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-08-20\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-08-24\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"Takeda\\\",\\\"class\\\":\\\"INDUSTRY\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":true,\\\"isFdaRegulatedDevice\\\":false,\\\"isUsExport\\\":true},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\\\\n\\\\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\\\\n\\\\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Myelofibrosis\\\",\\\"Anemia\\\"],\\\"keywords\\\":[\\\"TAK-226\\\",\\\"Drug therapy\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"TRIPLE\\\",\\\"whoMasked\\\":[\\\"PARTICIPANT\\\",\\\"CARE_PROVIDER\\\",\\\"INVESTIGATOR\\\"]}},\\\"enrollmentInfo\\\":{\\\"count\\\":324,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Elritercept\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) subcutaneously (SC) once every 4 weeks (Q4W) on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period, with possible up-titration to 5.0 mg/kg from Cycle 3 Day 1 based on response and safety/tolerability. Participants may continue to receive elritercept during the extended open-label treatment period.\\\",\\\"interventionNames\\\":[\\\"Drug: Elritercept\\\"]},{\\\"label\\\":\\\"Placebo\\\",\\\"type\\\":\\\"PLACEBO_COMPARATOR\\\",\\\"description\\\":\\\"Participants will receive elritercept-matching placebo with equivalent volume to elritercept SC Q4W on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period. Eligible participants may initiate elritercept at a starting dose of 3.75 mg/kg SC Q4W on Day 1 of each 28-day cycle during the extended open-label treatment period, with possible up-titration to 5.0 mg/kg after 2 cycles, based on response and safety/tolerability.\\\",\\\"interventionNames\\\":[\\\"Drug: Placebo\\\",\\\"Drug: Elritercept\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Placebo\\\",\\\"description\\\":\\\"Elritercept-matching placebo\\\",\\\"armGroupLabels\\\":[\\\"Placebo\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Elritercept\\\",\\\"description\\\":\\\"Elritercept, SC, injection\\\",\\\"armGroupLabels\\\":[\\\"Elritercept\\\",\\\"Placebo\\\"],\\\"otherNames\\\":[\\\"TAK-226\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Proportion of Participants Who Are Red Blood Cell-Transfusion Independent (RBC-TI) for Any Consecutive Greater Than or Equal to (≥) 12-Week Period During the 36-Week Double-Blinded Treatment Period\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive ≥16-Week Period\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hemoglobin (Hgb) Increase ≥1.5 Grams per Deciliter (g/dL) From Baseline\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive ≥24-Week Period\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hgb Increase of ≥1.0 g/dL and ≥2.0 g/dL From Baseline\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive 16- or 24-Week Period With a Concurrent Mean Hgb Increase of ≥1.0 g/dL, ≥1.5 g/dL, and ≥2.0 g/dL From Baseline\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Maximum Duration of RBC-TI for Participants Who Achieved RBC-TI for a Consecutive ≥12 Weeks\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Maximum Duration of RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL for Participants Who Achieved Consecutive ≥12 Weeks RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Onset of Anemia Response\\\",\\\"description\\\":\\\"Time to onset of anemia response is defined as the duration between the date of randomization and the date participant first achieved anemia response status. Anemia response is evaluated as: achievement of RBC-TI for any consecutive ≥12-week, ≥16-week, or ≥24-week period or ≥50% reduction in red blood cell transfusion burden from baseline over any consecutive 12 weeks.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a T-Score at Week 36\\\",\\\"description\\\":\\\"PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service.\\\",\\\"timeFrame\\\":\\\"Baseline, Week 36\\\"},{\\\"measure\\\":\\\"Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue Scale Score at Week 36\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participants with cancer. The questionnaire's items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, and pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, and diarrhea) as well as financial difficulties, and a 2-item scale measuring global health status (GHS))/quality of life (QoL). Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, GHS/QoL, or worse symptomatology.\\\",\\\"timeFrame\\\":\\\"Baseline, Week 36\\\"},{\\\"measure\\\":\\\"Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-score\\\",\\\"description\\\":\\\"PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-Score From Baseline\\\",\\\"description\\\":\\\"PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score From Baseline\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Mean Changes From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 7-Item Total Symptom Score at Week 36\\\",\\\"description\\\":\\\"MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The Total Symptom Score (TSS) is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.\\\",\\\"timeFrame\\\":\\\"Baseline, Week 36\\\"},{\\\"measure\\\":\\\"Proportion of Participants Achieving Confirmed 50% Reduction in MFSAF v4.0 Total Symptom Score (TSS50)\\\",\\\"description\\\":\\\"MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Symptom Response in MFSAF TSS50 From Baseline\\\",\\\"description\\\":\\\"MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Mean Change From Baseline EORTC QLQ-C30 Physical Functioning Scale Score at Week 36\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning.\\\",\\\"timeFrame\\\":\\\"Baseline, Week 36\\\"},{\\\"measure\\\":\\\"Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score From Baseline\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants With Platelet Response During the 36-Week Double-Blinded Treatment Period\\\",\\\"description\\\":\\\"Platelet response includes a mean increase of ≥30×10\\\\\\\\^9/ liter (L) from baseline, a \\\\\\\\\\u003e50% increase from baseline with a count ≥50×10\\\\\\\\^9/L, and conversion from \\\\\\\\\\u003c100 to ≥100×10\\\\\\\\^9/L, each sustained for ≥12 weeks.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Achieving Spleen Volume Reduction (SVR) From Baseline as Measured by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) During the 36-Week Double-Blinded Treatment Period\\\",\\\"description\\\":\\\"Proportion of participants achieving SVR of ≥10%, ≥25%, or ≥35% will be presented for this outcome measure.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Develop Accelerated Phase (AP) MF\\\",\\\"timeFrame\\\":\\\"Up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Time to Progression in Participants Who Develop AP MF\\\",\\\"timeFrame\\\":\\\"Up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Develop Blast Phase (BP) MF\\\",\\\"timeFrame\\\":\\\"Up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Time to Progression in Participants Who Develop BP MF\\\",\\\"timeFrame\\\":\\\"Up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Plasma Concentration-Time Data for Participants Treated With Elritercept\\\",\\\"timeFrame\\\":\\\"At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Proportion of Participants Treated With Elritercept who Have Antidrug Antibodies\\\",\\\"timeFrame\\\":\\\"At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Overall Survival (OS)\\\",\\\"description\\\":\\\"OS is defined as the time from randomization to the date of death due to any cause.\\\",\\\"timeFrame\\\":\\\"From randomization to 7 years\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Inclusion Criteria:\\\\n\\\\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\\\\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\\\\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\\\\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\\\\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\\\\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\\\\n\\\\nExclusion Criteria:\\\\n\\\\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\\\\n2. Systemic treatment within 28 days before randomization with any of the following:\\\\n\\\\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\\\\n   2. erythropoiesis-stimulating agents.\\\\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\\\\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\\\\n   5. Hydroxyurea.\\\\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\\\\n   7. Interferon.\\\\n   8. Thrombopoietin receptor agonists.\\\\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\\\\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\\\\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\\\\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\\\\n6. Life expectancy \\\\\\\\\\u003c12 months per investigator's judgment.\\\\n7. Clinically significant cardiovascular disease, defined as:\\\\n\\\\n   1. New York Heart Association heart disease Class III or IV;\\\\n   2. Fridericia corrected QT interval \\\\\\\\\\u003e500 millisecond (ms) during screening;\\\\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\\\\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.\\\\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\\\\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\\\\n\\\\n    1. Basal or squamous cell carcinoma of the skin;\\\\n    2. Carcinoma in situ of the cervix;\\\\n    3. Carcinoma in situ of the breast; and/or\\\\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);\\\\n    5. Early papillary thyroid cancer (stage I \\\\\\\\[T1-T2, N0, M0\\\\\\\\]).\\\\n11. History of solid organ or bone marrow transplantation.\\\\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.\\\\n13. 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Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"420532233642\\\",\\\"email\\\":\\\"Weinbergerova.Barbora@fnbrno.cz\\\"},{\\\"name\\\":\\\"Barbora Weinbergerova\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":49.19522,\\\"lon\\\":16.60796}},{\\\"facility\\\":\\\"Fakultni nemocnice Hradec Kralove\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Hradec Králové\\\",\\\"state\\\":\\\"CZ\\\",\\\"zip\\\":\\\"50005\\\",\\\"country\\\":\\\"Czechia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"420495833837\\\",\\\"email\\\":\\\"petra.belohlavkova@fnhk.cz\\\"},{\\\"name\\\":\\\"Petra Belohlavkova\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":50.20923,\\\"lon\\\":15.83277}},{\\\"facility\\\":\\\"Vseobecna fakultni nemocnice 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Nice\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Nice\\\",\\\"state\\\":\\\"Alpes Maritimes\\\",\\\"zip\\\":\\\"6002\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"492035558\\\",\\\"email\\\":\\\"loschi.m@chu-nice.fr\\\"},{\\\"name\\\":\\\"Michael Loschi\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":43.70313,\\\"lon\\\":7.26608}},{\\\"facility\\\":\\\"Centre Hospitalier Lyon Sud\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Pierre-Bénite\\\",\\\"state\\\":\\\"Auvergne-Rhône-Alpes\\\",\\\"zip\\\":\\\"69495\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"33478861323\\\",\\\"email\\\":\\\"vincent.alcazer@chu-lyon.fr\\\"},{\\\"name\\\":\\\"Vincent Alcazer\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":45.70359,\\\"lon\\\":4.82424}},{\\\"facility\\\":\\\"CHU de Strasbourg\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Strasbourg\\\",\\\"state\\\":\\\"Bas Rhin\\\",\\\"zip\\\":\\\"67200\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"03 68 76 73 01\\\",\\\"email\\\":\\\"shanti.ame@chru-strasbourg.fr\\\"},{\\\"name\\\":\\\"Shanti Ame\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":48.58392,\\\"lon\\\":7.74553}},{\\\"facility\\\":\\\"Institut Paoli Calmettes\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Marseille\\\",\\\"state\\\":\\\"Bouches-du-Rhone\\\",\\\"zip\\\":\\\"13009\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"33491223868\\\",\\\"email\\\":\\\"reyj@ipc.unicancer.fr\\\"},{\\\"name\\\":\\\"Jerome Rey\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":43.29695,\\\"lon\\\":5.38107}},{\\\"facility\\\":\\\"Centre Hospitalier Regional Universitaire Brest Hopital Morvan\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Brest\\\",\\\"state\\\":\\\"Finistere\\\",\\\"zip\\\":\\\"29609\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"33298223786\\\",\\\"email\\\":\\\"jean-christophe.ianotto@chu-brest.fr\\\"},{\\\"name\\\":\\\"Jean-Christophe Ianotto\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":48.39029,\\\"lon\\\":-4.48628}},{\\\"facility\\\":\\\"CHU de 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Wemeau\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":50.63391,\\\"lon\\\":3.05512}},{\\\"facility\\\":\\\"Assistance Publique Hopitaux de Paris\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Paris\\\",\\\"state\\\":\\\"Paris\\\",\\\"zip\\\":\\\"75015\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"33142385270\\\",\\\"email\\\":\\\"lina.benajiba@aphp.fr\\\"},{\\\"name\\\":\\\"Lina Benajiba\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":48.85341,\\\"lon\\\":2.3488}},{\\\"facility\\\":\\\"CHU de Poitiers\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Poitiers\\\",\\\"state\\\":\\\"Vienne\\\",\\\"zip\\\":\\\"86021\\\",\\\"country\\\":\\\"\n[...truncated]",
  "error": "",
  "elapsed": 0.196484452
}

{
  "tool_name": "shell",
  "tool_input": {
    "command": "cd /workspace/work && python3 - <<'EOF'\nimport json\np=\"/workspace/.hark/tool-results/db7ac1d0-b403-47ab-becb-155c213d55ea/bbf5b196d272a91042c97c14728b6e569768436b9bae62fd40a842349fefedfd.txt\"\nraw=json.load(open(p))\ndata=json.loads(raw[\"content\"])\nprint(data[\"totalCount\"], len(data[\"studies\"]), data.get(\"nextPageToken\"))\nEOF"
  },
  "dispatch_id": "toolu_bdrk_01MUQ4kMUMGEvJ2g7te1fQik",
  "parent_dispatch_id": "",
  "handle": "",
  "panel_kind": "shell"
}

{
  "tool_name": "shell",
  "dispatch_id": "toolu_bdrk_01MUQ4kMUMGEvJ2g7te1fQik",
  "status": "running",
  "result": null,
  "error": "",
  "elapsed": null,
  "fields": {
    "progress": {
      "message": "",
      "metadata": {
        "browser_chain": false,
        "command": "cd /workspace/work && python3 - <<'EOF'\nimport json\np=\"/workspace/.hark/tool-results/db7ac1d0-b403-4...",
        "phase": "starting"
      }
    },
    "status": "running",
    "updatedAt": 1789169501242
  }
}

{
  "tool_name": "shell",
  "dispatch_id": "toolu_bdrk_01MUQ4kMUMGEvJ2g7te1fQik",
  "status": "completed",
  "result": "55 30 ZVt07cGHkvI2wRk2CJf6_LLtz5GYPNRrd7KrgP4blDyUvPs8IQ\n",
  "error": "",
  "elapsed": 0.109393225
}

{
  "tool_name": "web_fetch",
  "tool_input": {
    "brief": "Phase 3 interventional recruiting studies with start date 2026-08-28 to 2026-09-11",
    "url": "https://clinicaltrials.gov/api/v2/studies?query.term=%5BREDACTED%5D&filter.overallStatus=%5BREDACTED%5D&aggFilters=%5BREDACTED%5D&pageSize=%5BREDACTED%5D&countTotal=%5BREDACTED%5D"
  },
  "dispatch_id": "toolu_bdrk_01HWnUsnUPbXrmYAJzFvLQQu",
  "parent_dispatch_id": "",
  "handle": "",
  "panel_kind": "web_fetch"
}

{
  "tool_name": "web_fetch",
  "dispatch_id": "toolu_bdrk_01HWnUsnUPbXrmYAJzFvLQQu",
  "status": "running",
  "result": null,
  "error": "",
  "elapsed": null,
  "fields": {
    "progress": {
      "message": "Phase 3 interventional recruiting studies with start date 2026-08-28 to 2026-09-11",
      "metadata": {
        "browser_chain": false,
        "url": "https://clinicaltrials.gov/api/v2/studies?query.term=%5BREDACTED%5D&filter.overallStatus=%5BREDACTED%5D&aggFilters=%5BREDACTED%5D&pageSize=%5BREDACTED%5D&countTotal=%5BREDACTED%5D"
      }
    },
    "status": "running",
    "updatedAt": 1789169507162
  }
}

{
  "tool_name": "web_fetch",
  "dispatch_id": "toolu_bdrk_01HWnUsnUPbXrmYAJzFvLQQu",
  "status": "completed",
  "result": "{\"content\":\"{\\\"totalCount\\\":44,\\\"studies\\\":[\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07738172\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"202605130RINE\\\"},\\\"organization\\\":{\\\"fullName\\\":\\\"National Taiwan University Hospital\\\",\\\"class\\\":\\\"OTHER\\\"},\\\"briefTitle\\\":\\\"Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer\\\",\\\"officialTitle\\\":\\\"A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy\\\",\\\"acronym\\\":\\\"PTR-2\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-09\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-09-08\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2031-08-01\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2031-08-01\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-07-23\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-07-28\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-07-31\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-09-07\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-09-09\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"PRINCIPAL_INVESTIGATOR\\\",\\\"investigatorFullName\\\":\\\"Statistical Center, NTUHCTC\\\",\\\"investigatorTitle\\\":\\\"National Taiwan University Hospital\\\",\\\"investigatorAffiliation\\\":\\\"National Taiwan University Hospital\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"National Taiwan University Hospital\\\",\\\"class\\\":\\\"OTHER\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":false,\\\"isFdaRegulatedDrug\\\":false,\\\"isFdaRegulatedDevice\\\":false,\\\"isUsExport\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Although osimertinib can provide effective disease control, most patients eventually experience disease progression, and the primary lung tumor may remain an important site of treatment resistance.\\\\n\\\\nThis multicenter, randomized, open-label phase III trial will evaluate whether surgical removal of the primary lung tumor, in addition to continued osimertinib treatment, prolongs progression-free survival in patients with EGFR-mutated oligometastatic non-small cell lung cancer.\\\\n\\\\nAll participants will initially receive osimertinib 80 mg orally once daily for 12 weeks. Participants who have a partial response or stable disease according to RECIST version 1.1 and remain suitable for surgery will be randomly assigned in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib. The study will also evaluate overall survival, safety, pathologic response, quality of life, patterns of disease progression, and changes in molecular biomarkers.\\\",\\\"detailedDescription\\\":\\\"This is a multicenter, open-label, parallel-group, randomized controlled phase III trial evaluating primary lung tumor resection in patients with EGFR-mutated oligometastatic stage IV non-small cell lung cancer treated with first-line osimertinib.\\\\n\\\\nThe study includes two eligibility assessments. During the first assessment, participants must have histologically or cytologically confirmed stage IV non-small cell lung cancer harboring an EGFR exon 19 deletion or exon 21 L858R mutation, a dominant and potentially resectable primary lung tumor, no more than three involved organs, and no more than 10 distant metastatic lesions.\\\\n\\\\nAll enrolled participants will receive protocol-defined induction treatment with osimertinib 80 mg orally once daily for 12 weeks. After induction, participants will undergo restaging. Only participants with partial response or stable disease according to RECIST version 1.1 who remain medically and technically suitable for primary lung tumor resection will undergo randomization.\\\\n\\\\nEligible participants will be randomly assigned in a 1:1 ratio to one of two groups:\\\\n\\\\n1. Osimertinib alone; or\\\\n2. Primary lung tumor resection followed by continued osimertinib. Randomization will be stratified by EGFR mutation subtype, presence of brain metastases, and number of distant metastatic lesions.\\\\n\\\\nParticipants assigned to the surgical group will undergo therapeutic resection of the primary lung tumor after randomization. The surgical approach and extent of resection will be selected by the treating thoracic surgeon according to accepted standards of care. Osimertinib will generally be resumed 1 to 2 weeks after surgery when wound healing is considered adequate. Participants in both groups will continue osimertinib until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation.\\\\n\\\\nTumor assessments will be performed approximately every 12 weeks and evaluated according to RECIST version 1.1. Local treatment of distant metastatic lesions may be provided when clinically indicated according to standard of care and institutional practice for the PTR group, as permitted by the protocol.\\\\n\\\\nThe primary objective is to compare progression-free survival between the two treatment groups. Secondary and exploratory objectives include overall survival, treatment-related adverse events, pathologic response of the primary tumor, quality of life, local-regional progression-free survival, distant metastasis progression-free survival, brain metastasis progression-free survival, polymetastatic progression-free survival, systemic therapy-free survival, and exploratory molecular biomarker outcomes.\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Lung Neoplasms, Non-Small Cell Lung Cancer\\\"],\\\"keywords\\\":[\\\"non-small cell lung cancer (NSCLC)\\\",\\\"EGFR mutation\\\",\\\"stage IV non-small-cell lung cancer\\\",\\\"Osimertinib\\\",\\\"Primary tumor resection\\\",\\\"Oligometastatic non-small cell lung cancer\\\",\\\"Local consolidative therapy\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"interventionModelDescription\\\":\\\"All participants will receive 12 weeks of first-line osimertinib induction therapy before randomization. Participants with partial response or stable disease who remain eligible for surgery will be randomized in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib.\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"NONE\\\",\\\"maskingDescription\\\":\\\"Because one treatment group undergoes surgery, participants and treating investigators will be aware of treatment assignment.\\\"}},\\\"enrollmentInfo\\\":{\\\"count\\\":154,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Osimertinib Alone\\\",\\\"type\\\":\\\"ACTIVE_COMPARATOR\\\",\\\"description\\\":\\\"Participants will receive osimertinib 80 mg orally once daily for 12 weeks before randomization. After randomization, participants assigned to this arm will continue osimertinib 80 mg once daily until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation.\\\",\\\"interventionNames\\\":[\\\"Drug: Osimertinib\\\"]},{\\\"label\\\":\\\"Osimertinib Plus Primary Tumor Resection\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participants will receive osimertinib 80 mg orally once daily for 12 weeks before randomization. After randomization, participants assigned to this arm will undergo therapeutic resection of the primary lung tumor. Osimertinib will generally be resumed 1 to 2 weeks after surgery when wound healing is considered adequate and will be continued until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation.\\\",\\\"interventionNames\\\":[\\\"Procedure: Primary Tumor Resection\\\",\\\"Drug: Osimertinib\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"PROCEDURE\\\",\\\"name\\\":\\\"Primary Tumor Resection\\\",\\\"description\\\":\\\"Participants assigned to the experimental arm will undergo therapeutic resection of the primary lung tumor after randomization. Acceptable procedures include lobectomy, sleeve lobectomy, bilobectomy, segmentectomy, and wedge resection. The surgical approach may include video-assisted thoracic surgery or thoracotomy. Pneumonectomy and sleeve pneumonectomy are not permitted. The procedure is intended to achieve maximal regional disease control and tumor-free resection margins whenever feasible.\\\",\\\"armGroupLabels\\\":[\\\"Osimertinib Plus Primary Tumor Resection\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Osimertinib\\\",\\\"description\\\":\\\"Osimertinib will be administered orally at a dose of 80 mg once daily as first-line systemic therapy. Treatment will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or fulfillment of other protocol-defined discontinuation criteria. Dose interruption or reduction will be permitted for treatment-related adverse events according to the study protocol.\\\",\\\"armGroupLabels\\\":[\\\"Osimertinib Alone\\\",\\\"Osimertinib Plus Primary Tumor Resection\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Progression-Free Survival\\\",\\\"description\\\":\\\"Progression-free survival is defined as the time from randomization to the first documented occurrence of disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"From randomization to disease progression or death, assessed up to 24 months after randomization.\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Overall Survival\\\",\\\"description\\\":\\\"Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the end of follow-up will be censored at the date they were last known to be alive.\\\",\\\"timeFrame\\\":\\\"From randomization to death from any cause, assessed up to 48 months after randomization.\\\"},{\\\"measure\\\":\\\"Number of Participants With Treatment-Related Adverse Events\\\",\\\"description\\\":\\\"Treatment-related adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The number and proportion of participants experiencing treatment-related adverse events will be summarized by treatment group.\\\",\\\"timeFrame\\\":\\\"From the first dose of osimertinib through 28 days after the last dose\\\"},{\\\"measure\\\":\\\"Pathologic Response of the Primary Lung Tumor\\\",\\\"description\\\":\\\"Percentage of residual viable tumor cells in the resected primary lung tumor. Major pathologic response is defined as ≤10% residual viable tumor, and pathologic complete response as no residual viable tumor. This outcome will be assessed only in the surgical arm.\\\",\\\"timeFrame\\\":\\\"At primary lung tumor resection, generally within 12 weeks after randomization\\\"},{\\\"measure\\\":\\\"Change From Baseline in Quality-of-Life Score\\\",\\\"description\\\":\\\"Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, version 3.0 (EORTC QLQ-C30 v3.0), together with the lung cancer-specific module (EORTC QLQ-LC13). Scores for each scale and single-item measure are linearly transformed to a 0-100 scale. Higher scores on the QLQ-C30 Global Health Status/Quality of Life and functional scales indicate better quality of life or functioning, whereas higher scores on the QLQ-C30 symptom scales and QLQ-LC13 symptom scales or items indicate greater symptom burden. No combined total score will be calculated.\\\",\\\"timeFrame\\\":\\\"Before osimertinib induction, at week 12 before randomization, and at 12 and 24 months after randomization.\\\"}],\\\"otherOutcomes\\\":[{\\\"measure\\\":\\\"Local-Regional Progression-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to the first occurrence of progression in the primary lung tumor, ipsilateral thorax, regional lymph nodes, or pleura, or death from any cause, whichever occurs first. Participants without an event will be censored at their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"From randomization until locoregional progression or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Distant Metastasis Progression-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to the first occurrence of distant progression, a new distant metastatic lesion, or death from any cause, whichever occurs first. Participants without an event will be censored at their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"Time Frame: From randomization until distant progression or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Brain Metastasis Progression-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to the first occurrence of intracranial progression, a new brain metastasis, or death from any cause, whichever occurs first. Participants without an event will be censored at their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"From randomization until intracranial progression or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Polymetastatic Progression-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to the first radiographic documentation of more than 10 distant metastatic lesions or death from any cause, whichever occurs first. Participants without an event will be censored at their last adequate disease assessment.\\\",\\\"timeFrame\\\":\\\"From randomization until polymetastatic progression or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Start-or-Switch of Systemic Therapy-Free Survival\\\",\\\"description\\\":\\\"Time from randomization to initiation of a new systemic anticancer therapy, switching from the protocol-specified regimen to another systemic regimen, adding a new systemic anticancer agent because of disease progression, or death from any cause, whichever occurs first. Dose interruption, dose reduction, dose re-escalation, or postoperative resumption of protocol-specified osimertinib will not be considered events.\\\",\\\"timeFrame\\\":\\\"From randomization until systemic therapy initiation, treatment switch, or death, assessed up to 5 years\\\"},{\\\"measure\\\":\\\"Plasma EGFR-Mutant Circulating Tumor DNA Variant Allele Frequency\\\",\\\"description\\\":\\\"Plasma circulating tumor DNA will be measured using next-generation sequencing. The variant allele frequency of the tumor-specific EGFR mutation will be expressed as a percentage. Change from baseline will be calculated as the variant allele frequency at each postbaseline assessment minus the baseline variant allele frequency and reported in percentage points.\\\",\\\"timeFrame\\\":\\\"Baseline before the first dose of osimertinib, Week 12, and Months 6, 12, 18, and 24\\\"},{\\\"measure\\\":\\\"Serum Carcinoembryonic Antigen Concentration\\\",\\\"description\\\":\\\"Serum carcinoembryonic antigen concentration will be measured using a clinical laboratory immunoassay and expressed in nanograms per milliliter (ng/mL).\\\",\\\"timeFrame\\\":\\\"Baseline before the first dose of osimertinib, Week 12, and Months 6, 12, 18, and 24\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"This study consists of 2 screening phases:\\\\n\\\\nPart 1 screening (before osimertinib induction):\\\\n\\\\nPatients must meet the baseline eligibility criteria, including stage IV NSCLC, EGFR sensitizing mutation (exon 19 deletion or L858R), resectable dominant primary lung lesion, and adequate performance status and organ function.\\\\n\\\\nPart 2 screening (after 12 weeks of protocol-defined osimertinib induction and before randomization):\\\\n\\\\nPatients must complete 12 weeks of osimertinib 80 mg once daily and undergo restaging evaluation. Only patients with partial response (PR) or stable disease (SD) by RECIST 1.1, and who remain suitable for thoracic surgery, will proceed to randomization.\\\\n\\\\nDisease distribution must satisfy all of the following: no more than 3 involved organs, one dominant pulmonary primary lesion, the maximal diameter of the dominant primary lung lesion greater than any individual distant metastatic lesion, and a total number of distant metastatic lesions fewer or equal than 10. Pleural or peritoneal metastasis confined to a single cavity and amenable to treatment may be considered a single metastatic lesion.\\\\n\\\\nInclusion criteria for screening part 1\\\\n\\\\n1. Histologically or cytologically confirmed NSCLC.\\\\n2. Age ≥18 years.\\\\n3. AJCC 8th edition stage IV NSCLC.\\\\n4. EGFR sensitizing mutation limited to exon 19 deletion or exon 21 L858R.\\\\n5. WHO performance status 0-1. Patients with brain metastases must be conscious; patients with bone metastases must not have irreversible severe events such as severe pathological fracture.\\\\n6. The primary lung tumor is considered resectable by the investigator and thoracic surgeon, with surgery intended for maximal regional control.\\\\n7. The patient is able to take oral medication and is expected to receive first-line osimertinib induction therapy.\\\\n8. Major organ function and pulmonary reserve are adequate to tolerate the planned surgery.\\\\n\\\\nInclusion Criteria for Screening Part 2\\\\n\\\\nSubjects may proceed to randomization only if all of the following criteria are met:\\\\n\\\\n1. The subject has received first-line protocol-defined osimertinib induction according to the study protocol, consisting of osimertinib once daily (QD) for 12 weeks, and has completed the pre-randomization evaluation.\\\\n2. Restaging imaging has been completed after 12 weeks of induction therapy, and the response is assessed as partial response (PR) or stable disease (SD) according to RECIST version 1.1. In addition, the maximal diameter of the target primary lung tumor before surgery must be greater than the sum of the maximal diameters of the metastatic tumors. PET-CT before surgery or before randomization is recommended to evaluate for newly developed extrathoracic metastases, bone metastases, or mediastinal lymph node involvement. If PET-CT is not performed, the preoperative or pre-randomization imaging assessment should include contrast-enhanced CT scans of the chest and abdomen, including the liver and adrenal glands; brain imaging should be completed with contrast-enhanced CT or MRI. Pleural or peritoneal metastasis confined to a single cavity (for example, unilateral pleural disease) and amenable to treatment may be considered a single metastatic lesion.\\\\n3. Disease distribution after induction therapy meeting all of the following criteria:\\\\n\\\\n   1. no more than 3 involved organs;\\\\n   2. one dominant pulmonary primary lesion;\\\\n   3. the maximal diameter of the dominant pulmonary primary lesion is greater than any single distant metastatic lesion;\\\\n   4. total number of distant metastatic lesions fewer or equal to 10.\\\\n4. After 12 weeks of protocol-defined osimertinib induction, the patient must have PR or SD by RECIST 1.1 and remain eligible for randomization.\\\\n\\\\n   If either of the following conditions is present on restaging imaging:\\\\n   1. Poor primary tumor response: the sum of the longest diameters (SLD) of the primary lung tumor after treatment falls within the range of less than 30% decrease and less than 20% increase (that is, -30% \\\\\\\\\\u003c SLD change \\\\\\\\\\u003c +20%); or\\\\n   2. Polymetastatic condition: the total number of distant metastatic lesions is 6 to 10,\\\\n\\\\n   then the treatment response of the other distant target metastatic lesions must additionally meet an SLD reduction of at least 30% in order for the subject to remain eligible for randomization.\\\\n5. Estimated life expectancy is greater than 3 months, as judged by the investigator.\\\\n6. The subject remains suitable for primary lung tumor resection, as assessed by the investigator and thoracic surgeon, and has no major comorbidity that would increase surgical risk to an unacceptable level.\\\\n\\\\nExclusion criteria Subjects meeting any of the following criteria will be excluded from this study. If any of these conditions are identified only after completion of the 12-week induction phase, the subject will not proceed to randomization.\\\\n\\\\n1. Pathology other than non-small cell lung cancer (NSCLC), or failure to meet the EGFR mutation criteria specified in this study.\\\\n2. EGFR mutation other than exon 19 deletion or exon 21 L858R.\\\\n3. Involvement of more than 3 organs by tumor lesions at post-induction restaging, before randomization.\\\\n4. Total number of distant metastatic lesions greater than 10 at post-induction restaging, before randomization.\\\\n5. No clearly dominant primary pulmonary lesion, or the maximal diameter of the dominant primary pulmonary lesion is not greater than any individual distant metastatic lesion at post-induction restaging, before randomization\\\\n6. Diffuse pleural or peritoneal carcinomatosis that cannot be clearly localized and treated with local definitive therapy.\\\\n7. Progressive disease (PD) on imaging evaluation after 12 weeks of protocol-defined osimertinib induction.\\\\n8. Judged by the investigator or thoracic surgeon to be no longer suitable for thoracic surgery after induction therapy.\\\\n9. Any systemic therapy other than the protocol-defined osimertinib induction for the current stage IV NSCLC.\\\\n10. Any prior EGFR-TKI, chemotherapy, immunotherapy, or other systemic anticancer therapy for the current stage IV NSCLC, except for the protocol-defined osimertinib induction.\\\\n11. Pregnant, breastfeeding, or planning pregnancy during the study period.\\\\n12. Any condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study, or highly likely to be unable to comply with the study procedures, restrictions, or requirements.\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"ALL\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"Chong-Jen Yu, MD\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"+886-2-2322-0322\\\",\\\"email\\\":\\\"jefferycjyu@ntu.edu.tw\\\"}],\\\"overallOfficials\\\":[{\\\"name\\\":\\\"Chong-Jen Yu, MD\\\",\\\"affiliation\\\":\\\"National Taiwan University Hospital\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"National Taiwan University Hospital\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Taipei\\\",\\\"state\\\":\\\"Taipei City\\\",\\\"zip\\\":\\\"100\\\",\\\"country\\\":\\\"Taiwan\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Dobbie Pei-Hsing Chen, MD\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"+886-2-2322-0322\\\",\\\"email\\\":\\\"chenph@ntu.edu.tw\\\"},{\\\"name\\\":\\\"Chong-Jen Yu, MD\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"},{\\\"name\\\":\\\"Jin-Shing Chen, MD,PhD\\\",\\\"role\\\":\\\"SUB_INVESTIGATOR\\\"},{\\\"name\\\":\\\"Dobbie Pei-Hsing Chen, MD\\\",\\\"role\\\":\\\"SUB_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":25.05306,\\\"lon\\\":121.52639}}]},\\\"ipdSharingStatementModule\\\":{\\\"ipdSharing\\\":\\\"UNDECIDED\\\",\\\"description\\\":\\\"The individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant-level data will be subject to applicable ethical approvals, institutional policies, data-use agreements, and protection of participant confidentiality.\\\"}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D008175\\\",\\\"term\\\":\\\"Lung Neoplasms\\\"},{\\\"id\\\":\\\"D002289\\\",\\\"term\\\":\\\"Carcinoma, Non-Small-Cell Lung\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D012142\\\",\\\"term\\\":\\\"Respiratory Tract Neoplasms\\\"},{\\\"id\\\":\\\"D013899\\\",\\\"term\\\":\\\"Thoracic Neoplasms\\\"},{\\\"id\\\":\\\"D009371\\\",\\\"term\\\":\\\"Neoplasms by Site\\\"},{\\\"id\\\":\\\"D009369\\\",\\\"term\\\":\\\"Neoplasms\\\"},{\\\"id\\\":\\\"D008171\\\",\\\"term\\\":\\\"Lung Diseases\\\"},{\\\"id\\\":\\\"D012140\\\",\\\"term\\\":\\\"Respiratory Tract Diseases\\\"},{\\\"id\\\":\\\"D002283\\\",\\\"term\\\":\\\"Carcinoma, Bronchogenic\\\"},{\\\"id\\\":\\\"D001984\\\",\\\"term\\\":\\\"Bronchial Neoplasms\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"C000596361\\\",\\\"term\\\":\\\"osimertinib\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07640789\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"BL-B01D1-318\\\"},\\\"organization\\\":{\\\"fullName\\\":\\\"Sichuan Baili Pharmaceutical Co., Ltd.\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)\\\",\\\"officialTitle\\\":\\\"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-09\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-08-28\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2030-12\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2030-12\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-06-07\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-06-07\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-06-11\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-09-08\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-09-10\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"Sichuan Baili Pharmaceutical Co., Ltd.\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"collaborators\\\":[{\\\"name\\\":\\\"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.\\\",\\\"class\\\":\\\"INDUSTRY\\\"}]},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":false,\\\"isFdaRegulatedDevice\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.\\\",\\\"detailedDescription\\\":\\\"In this trial, the treatment group receives BL-B01D1 in combination with osimertinib, while the control group receives osimertinib monotherapy.\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Non-small Cell Lung Cancer Stage III\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"NONE\\\"}},\\\"enrollmentInfo\\\":{\\\"count\\\":418,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"BL-B01D1+Osimertinib\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participants receive BL-B01D1+Osimertinib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.\\\",\\\"interventionNames\\\":[\\\"Drug: BL-B01D1\\\",\\\"Drug: Osimertinib\\\"]},{\\\"label\\\":\\\"Osimertinib\\\",\\\"type\\\":\\\"ACTIVE_COMPARATOR\\\",\\\"description\\\":\\\"Participants receive Osimertinib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.\\\",\\\"interventionNames\\\":[\\\"Drug: Osimertinib\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"BL-B01D1\\\",\\\"description\\\":\\\"Administration by intravenous infusion for a cycle of 3 weeks.\\\",\\\"armGroupLabels\\\":[\\\"BL-B01D1+Osimertinib\\\"],\\\"otherNames\\\":[\\\"iza-bren\\\",\\\"izalontamab brengitecan\\\",\\\"BMS-986507\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Osimertinib\\\",\\\"description\\\":\\\"Oral administration for a cycle of 3 weeks.\\\",\\\"armGroupLabels\\\":[\\\"BL-B01D1+Osimertinib\\\",\\\"Osimertinib\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Progression-free survival (PFS)\\\",\\\"description\\\":\\\"Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Overall Survival (OS)\\\",\\\"description\\\":\\\"Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Objective Response Rate (ORR)\\\",\\\"description\\\":\\\"Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Disease Control Rate (DCR)\\\",\\\"description\\\":\\\"Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Duration of Response (DOR)\\\",\\\"description\\\":\\\"Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Treatment Emergent Adverse Event (TEAE)\\\",\\\"description\\\":\\\"TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"},{\\\"measure\\\":\\\"Anti-drug antibody (ADA)\\\",\\\"description\\\":\\\"Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.\\\",\\\"timeFrame\\\":\\\"Up to approximately 24 months\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Inclusion Criteria:\\\\n\\\\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\\\\n2. Age ≥ 18 years and ≤ 75 years, regardless of gender;\\\\n3. Expected survival time ≥ 3 months;\\\\n4. Unresectable Stage III non-small cell lung cancer;\\\\n5. Detection of one of the EGFR-sensitive mutation types in tumor tissue;\\\\n6. Agree to provide archived primary tumor tissue specimens or fresh tissue samples within 1 year;\\\\n7. In platinum-based radical chemoradiotherapy, the platinum-containing chemotherapy regimen must include one of the specified drugs in addition to the platinum agent;\\\\n8. In platinum-based radical chemoradiotherapy, patients must have received a total radiation dose of 60 Gy ± 10% before randomization;\\\\n9. Toxicities from prior chemoradiotherapy must have resolved to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\\\\n10. ECOG performance status score of 0 or 1;\\\\n11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\\\\n12. Organ function levels must meet the requirements;\\\\n13. Urine protein ≤ 1+ or \\\\\\\\\\u003c 1000 mg/24h;\\\\n14. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the test must rule out pregnancy; they must not be lactating; all enrolled trial participants must take adequate barrier contraceptive measures throughout the treatment period and for 7 months after treatment ends.\\\\n\\\\nExclusion Criteria:\\\\n\\\\n1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;\\\\n2. The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy;\\\\n3. Major surgery within 4 weeks prior to the first dose;\\\\n4. Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies/ADCs targeting EGFR and/or HER3;\\\\n5. History of severe heart disease or cerebrovascular disease;\\\\n6. Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\\\\n7. Any thrombotic events such as deep vein thrombosis, arterial thrombosis, or pulmonary embolism within 6 months prior to screening;\\\\n8. Diagnosis of active malignancy within 5 years prior to study randomization;\\\\n9. Hypertension poorly controlled by two antihypertensive medications;\\\\n10. Trial participants with poorly controlled blood glucose levels;\\\\n11. Current radiation pneumonitis of Grade ≥2 as defined by CTCAE;\\\\n12. Concurrent lung disease resulting in clinically severe respiratory impairment;\\\\n13. Severe infection within 4 weeks prior to study randomization;\\\\n14. Large serous cavity effusions or symptomatic serous cavity effusions;\\\\n15. Imaging findings suggesting tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;\\\\n16. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;\\\\n17. Trial participants with clinically significant bleeding or a clear tendency for bleeding within 4 weeks prior to signing informed consent;\\\\n18. Trial participants with a history of inflammatory bowel disease, extensive bowel resection, or immune-mediated enteritis;\\\\n19. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug;\\\\n20. History of autologous or allogeneic stem cell transplantation;\\\\n21. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;\\\\n22. History of severe neurological or psychiatric disorders, or a history of substance abuse, alcoholism, or drug addiction;\\\\n23. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;\\\\n24. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other reasons.\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"ALL\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"maximumAge\\\":\\\"75 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"Sa Xiao, PHD\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"15013238943\\\",\\\"email\\\":\\\"xiaosa@baili-pharm.com\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"Cancer Hospital of Shandong First Medical University\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Jinan\\\",\\\"state\\\":\\\"Shandong\\\",\\\"country\\\":\\\"China\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Jinming Yu\\\",\\\"role\\\":\\\"CONTACT\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":36.66833,\\\"lon\\\":116.99722}}]}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D002289\\\",\\\"term\\\":\\\"Carcinoma, Non-Small-Cell Lung\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D002283\\\",\\\"term\\\":\\\"Carcinoma, Bronchogenic\\\"},{\\\"id\\\":\\\"D001984\\\",\\\"term\\\":\\\"Bronchial Neoplasms\\\"},{\\\"id\\\":\\\"D008175\\\",\\\"term\\\":\\\"Lung Neoplasms\\\"},{\\\"id\\\":\\\"D012142\\\",\\\"term\\\":\\\"Respiratory Tract Neoplasms\\\"},{\\\"id\\\":\\\"D013899\\\",\\\"term\\\":\\\"Thoracic Neoplasms\\\"},{\\\"id\\\":\\\"D009371\\\",\\\"term\\\":\\\"Neoplasms by Site\\\"},{\\\"id\\\":\\\"D009369\\\",\\\"term\\\":\\\"Neoplasms\\\"},{\\\"id\\\":\\\"D008171\\\",\\\"term\\\":\\\"Lung Diseases\\\"},{\\\"id\\\":\\\"D012140\\\",\\\"term\\\":\\\"Respiratory Tract Diseases\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"C000596361\\\",\\\"term\\\":\\\"osimertinib\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07686081\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"VP-VSP-128-3201\\\"},\\\"organization\\\":{\\\"fullName\\\":\\\"Vanda Pharmaceuticals\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis\\\",\\\"officialTitle\\\":\\\"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ponesimod in Patients With Moderately to Severely Active Ulcerative Colitis\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-08\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-09\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2029-04\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2029-08\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-06-30\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-06-30\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-07-07\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-08-14\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-08-18\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"Vanda Pharmaceuticals\\\",\\\"class\\\":\\\"INDUSTRY\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":true,\\\"isFdaRegulatedDevice\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active ulcerative colitis\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Ulcerative Colitis (UC)\\\"],\\\"keywords\\\":[\\\"ulcerative colitis\\\",\\\"moderately to severely active ulcerative colitis\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"QUADRUPLE\\\",\\\"whoMasked\\\":[\\\"PARTICIPANT\\\",\\\"CARE_PROVIDER\\\",\\\"INVESTIGATOR\\\",\\\"OUTCOMES_ASSESSOR\\\"]}},\\\"enrollmentInfo\\\":{\\\"count\\\":150,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Ponesimod (VSP-128)\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"interventionNames\\\":[\\\"Drug: Ponesimod\\\"]},{\\\"label\\\":\\\"Placebo\\\",\\\"type\\\":\\\"PLACEBO_COMPARATOR\\\",\\\"interventionNames\\\":[\\\"Drug: Placebo\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Ponesimod\\\",\\\"description\\\":\\\"Ponesimod administered orally once daily. Participants are randomized 2:1 to Ponesimod or placebo during a 16-week double-blind period. A 14-day titration is followed by a stable dose daily from Day 15 through end of treatment. Participants may enter a 36-week open-label extension receiving Ponesimod.\\\",\\\"armGroupLabels\\\":[\\\"Ponesimod (VSP-128)\\\"],\\\"otherNames\\\":[\\\"VSP-128\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Placebo\\\",\\\"description\\\":\\\"Matching placebo administered orally once daily during a 16-week double-blind period (2:1 randomization). A mock 14-day titration is used to maintain blinding. Participants may enter a 36-week open-label extension receiving Ponesimod.\\\",\\\"armGroupLabels\\\":[\\\"Placebo\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Clinical Remission at Week 16\\\",\\\"description\\\":\\\"Proportion of participants achieving clinical remission at Week 16.\\\",\\\"timeFrame\\\":\\\"Week 16\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Clinical Response at Week 16\\\",\\\"description\\\":\\\"Proportion of participants achieving clinical response at Week 16.\\\",\\\"timeFrame\\\":\\\"Week 16\\\"},{\\\"measure\\\":\\\"Change From Baseline in Mayo Score at Week 16\\\",\\\"description\\\":\\\"Change from baseline in the three-component Mayo Score at Week 16. The overall score value ranges from 0 to 9, with higher scores indicating more severe ulcerative colitis disease activity.\\\",\\\"timeFrame\\\":\\\"Baseline to Week 16.\\\"},{\\\"measure\\\":\\\"Endoscopic Improvement at Week 16\\\",\\\"description\\\":\\\"Proportion of participants achieving endoscopic improvement at Week 16.\\\",\\\"timeFrame\\\":\\\"Week 16\\\"},{\\\"measure\\\":\\\"Symptomatic Remission at Week 16\\\",\\\"description\\\":\\\"Proportion of participants achieving symptomatic remission at Week 16.\\\",\\\"timeFrame\\\":\\\"Week 16\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Inclusion Criteria:\\\\n\\\\n* Male and female subjects aged 18-75 years\\\\n* Able to provide written informed consent\\\\n* Diagnosis of ulcerative colitis for ≥90 days prior to screening\\\\n* Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1\\\\n* History of inadequate response, loss of response, or intolerance to at least one approved UC therapy\\\\n\\\\nExclusion Criteria:\\\\n\\\\n* Severe or fulminant UC likely to require hospitalization or surgery\\\\n* Diagnosis of Crohn's disease or other non-UC colitis\\\\n* Prior exposure to S1P receptor modulators\\\\n* Active or chronic infections\\\\n* Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease\\\\n* History of an allergic reaction or significant sensitivity to constituents of study drug\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"ALL\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"maximumAge\\\":\\\"75 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"Vanda Pharmaceuticals Inc.\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"202-734-3400\\\",\\\"email\\\":\\\"clinicaltrials@vandapharma.com\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"Vanda Investigational Site\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Chula Vista\\\",\\\"state\\\":\\\"California\\\",\\\"zip\\\":\\\"91910\\\",\\\"country\\\":\\\"United States\\\",\\\"geoPoint\\\":{\\\"lat\\\":32.64005,\\\"lon\\\":-117.0842}},{\\\"facility\\\":\\\"Vanda Investigational Site\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Nashville\\\",\\\"state\\\":\\\"Tennessee\\\",\\\"zip\\\":\\\"37211\\\",\\\"country\\\":\\\"United States\\\",\\\"geoPoint\\\":{\\\"lat\\\":36.16589,\\\"lon\\\":-86.78444}}]},\\\"ipdSharingStatementModule\\\":{\\\"ipdSharing\\\":\\\"NO\\\"}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D003093\\\",\\\"term\\\":\\\"Colitis, Ulcerative\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D003092\\\",\\\"term\\\":\\\"Colitis\\\"},{\\\"id\\\":\\\"D005759\\\",\\\"term\\\":\\\"Gastroenteritis\\\"},{\\\"id\\\":\\\"D005767\\\",\\\"term\\\":\\\"Gastrointestinal Diseases\\\"},{\\\"id\\\":\\\"D004066\\\",\\\"term\\\":\\\"Digestive System Diseases\\\"},{\\\"id\\\":\\\"D015212\\\",\\\"term\\\":\\\"Inflammatory Bowel Diseases\\\"},{\\\"id\\\":\\\"D003108\\\",\\\"term\\\":\\\"Colonic Diseases\\\"},{\\\"id\\\":\\\"D007410\\\",\\\"term\\\":\\\"Intestinal Diseases\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"C550169\\\",\\\"term\\\":\\\"ponesimod\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07564141\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"GCT1184-07\\\"},\\\"secondaryIdInfos\\\":[{\\\"id\\\":\\\"2025-524202-15-00\\\",\\\"type\\\":\\\"CTIS\\\"},{\\\"id\\\":\\\"jRCT2021260025\\\",\\\"type\\\":\\\"REGISTRY\\\",\\\"domain\\\":\\\"Japan Registry for Clinical Trials (jRCT)\\\"},{\\\"id\\\":\\\"GOG-3143\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"ENGOT-ov103\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"GEICO-177-O\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"APGOT-ov21\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"LACOG 0126-EVA\\\",\\\"type\\\":\\\"OTHER\\\",\\\"domain\\\":\\\"Other Identifier\\\"},{\\\"id\\\":\\\"2025\\\",\\\"type\\\":\\\"NIH\\\",\\\"link\\\":\\\"https://reporter.nih.gov/quickSearch/2025\\\"}],\\\"organization\\\":{\\\"fullName\\\":\\\"Genmab\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer\\\",\\\"officialTitle\\\":\\\"A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer\\\",\\\"acronym\\\":\\\"RAINFOL™-07\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-08\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-08-28\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2029-12\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2031-11\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-04-27\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-04-27\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-05-04\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-08-31\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-09-01\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"Genmab\\\",\\\"class\\\":\\\"INDUSTRY\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":true,\\\"isFdaRegulatedDevice\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.\\\\n\\\\nThe purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.\\\\n\\\\nParticipants will receive either:\\\\n\\\\n* Rina-S monotherapy (by itself),\\\\n* Rina-S plus bevacizumab,\\\\n* investigator's choice chemotherapy (by itself) (standard of care), or\\\\n* investigator's choice chemotherapy plus bevacizumab (standard of care).\\\\n\\\\nNo participants will be given placebo. Participants will participate in 1 of 2 arms.\\\\n\\\\nThe treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.\\\\n\\\\nParticipants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.\\\\n\\\\nThe overall study duration (including screening, treatment, and follow-up) will be different for every participant.\\\",\\\"detailedDescription\\\":\\\"This is a global, open-label, randomized, Phase 3 study of Rina-S ± bevacizumab versus investigator's choice (IC) ± bevacizumab as second-line (2L) treatment in participants with recurrent platinum-sensitive ovarian cancer (PSOC).\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Platinum-Sensitive Ovarian Cancer\\\",\\\"Ovarian Cancer\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"NONE\\\"}},\\\"enrollmentInfo\\\":{\\\"count\\\":688,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Arm 1: Rina-S ± Bevacizumab\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).\\\",\\\"interventionNames\\\":[\\\"Biological: Rina-S\\\",\\\"Drug: Bevacizumab\\\"]},{\\\"label\\\":\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\",\\\"type\\\":\\\"ACTIVE_COMPARATOR\\\",\\\"description\\\":\\\"Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.\\\",\\\"interventionNames\\\":[\\\"Drug: Bevacizumab\\\",\\\"Drug: Carboplatin\\\",\\\"Drug: Gemcitabine\\\",\\\"Drug: Paclitaxel\\\",\\\"Drug: PLD\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"BIOLOGICAL\\\",\\\"name\\\":\\\"Rina-S\\\",\\\"description\\\":\\\"Intravenous (IV) infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 1: Rina-S ± Bevacizumab\\\"],\\\"otherNames\\\":[\\\"Rinatabart Sesutecan\\\",\\\"GEN1184\\\",\\\"PRO1184\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Bevacizumab\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 1: Rina-S ± Bevacizumab\\\",\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Carboplatin\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Gemcitabine\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Paclitaxel\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"PLD\\\",\\\"description\\\":\\\"IV infusion\\\",\\\"armGroupLabels\\\":[\\\"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Overall Survival (OS)\\\",\\\"timeFrame\\\":\\\"Up to approximately 5 years\\\"},{\\\"measure\\\":\\\"PFS per RECIST v1.1, as Determined by Investigator\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Objective Response Rate (ORR) per RECIST v1.1\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Duration of Response (DOR) per RECIST v1.1\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Time to First Subsequent Therapy (TFST)\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Number of Participants with Treatment-emergent Adverse Events (TEAEs)\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)\\\",\\\"timeFrame\\\":\\\"Baseline up to approximately 3 years\\\"},{\\\"measure\\\":\\\"Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire\\\",\\\"timeFrame\\\":\\\"Up to approximately 3 years\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Key Inclusion Criteria:\\\\n\\\\n* Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.\\\\n* Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, \\\\\\\\\\u003e183 days) after their last dose administration of platinum-based therapy.\\\\n* Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.\\\\n* Participants must have measurable disease per RECIST v1.1 by investigator at baseline.\\\\n* All participants must provide a tumor specimen.\\\\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.\\\\n\\\\nKey Exclusion Criteria:\\\\n\\\\n* Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.\\\\n* Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.\\\\n* Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.\\\\n* Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).\\\\n\\\\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"FEMALE\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"Genmab Trial Information\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"+4570202728\\\",\\\"email\\\":\\\"clinicaltrials@genmab.com\\\"}],\\\"overallOfficials\\\":[{\\\"name\\\":\\\"Study Official\\\",\\\"affiliation\\\":\\\"Genmab\\\",\\\"role\\\":\\\"STUDY_DIRECTOR\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"Danbury Hospital\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Danbury\\\",\\\"state\\\":\\\"Connecticut\\\",\\\"zip\\\":\\\"06810\\\",\\\"country\\\":\\\"United States\\\",\\\"geoPoint\\\":{\\\"lat\\\":41.39482,\\\"lon\\\":-73.45401}},{\\\"facility\\\":\\\"ProHealth Care Inc\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Waukesha\\\",\\\"state\\\":\\\"Wisconsin\\\",\\\"zip\\\":\\\"53188\\\",\\\"country\\\":\\\"United States\\\",\\\"geoPoint\\\":{\\\"lat\\\":43.01168,\\\"lon\\\":-88.23148}}]},\\\"ipdSharingStatementModule\\\":{\\\"ipdSharing\\\":\\\"NO\\\"}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D010051\\\",\\\"term\\\":\\\"Ovarian Neoplasms\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D004701\\\",\\\"term\\\":\\\"Endocrine Gland Neoplasms\\\"},{\\\"id\\\":\\\"D009371\\\",\\\"term\\\":\\\"Neoplasms by Site\\\"},{\\\"id\\\":\\\"D009369\\\",\\\"term\\\":\\\"Neoplasms\\\"},{\\\"id\\\":\\\"D010049\\\",\\\"term\\\":\\\"Ovarian Diseases\\\"},{\\\"id\\\":\\\"D000291\\\",\\\"term\\\":\\\"Adnexal Diseases\\\"},{\\\"id\\\":\\\"D005831\\\",\\\"term\\\":\\\"Genital Diseases, Female\\\"},{\\\"id\\\":\\\"D052776\\\",\\\"term\\\":\\\"Female Urogenital Diseases\\\"},{\\\"id\\\":\\\"D005261\\\",\\\"term\\\":\\\"Female Urogenital Diseases and Pregnancy Complications\\\"},{\\\"id\\\":\\\"D000091642\\\",\\\"term\\\":\\\"Urogenital Diseases\\\"},{\\\"id\\\":\\\"D005833\\\",\\\"term\\\":\\\"Genital Neoplasms, Female\\\"},{\\\"id\\\":\\\"D014565\\\",\\\"term\\\":\\\"Urogenital Neoplasms\\\"},{\\\"id\\\":\\\"D000091662\\\",\\\"term\\\":\\\"Genital Diseases\\\"},{\\\"id\\\":\\\"D004700\\\",\\\"term\\\":\\\"Endocrine System Diseases\\\"},{\\\"id\\\":\\\"D006058\\\",\\\"term\\\":\\\"Gonadal Disorders\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D000068258\\\",\\\"term\\\":\\\"Bevacizumab\\\"},{\\\"id\\\":\\\"D016190\\\",\\\"term\\\":\\\"Carboplatin\\\"},{\\\"id\\\":\\\"D000093542\\\",\\\"term\\\":\\\"Gemcitabine\\\"},{\\\"id\\\":\\\"D017239\\\",\\\"term\\\":\\\"Paclitaxel\\\"},{\\\"id\\\":\\\"C041277\\\",\\\"term\\\":\\\"1-dodecylpyridoxal\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D061067\\\",\\\"term\\\":\\\"Antibodies, Monoclonal, Humanized\\\"},{\\\"id\\\":\\\"D000911\\\",\\\"term\\\":\\\"Antibodies, Monoclonal\\\"},{\\\"id\\\":\\\"D000906\\\",\\\"term\\\":\\\"Antibodies\\\"},{\\\"id\\\":\\\"D007136\\\",\\\"term\\\":\\\"Immunoglobulins\\\"},{\\\"id\\\":\\\"D007162\\\",\\\"term\\\":\\\"Immunoproteins\\\"},{\\\"id\\\":\\\"D001798\\\",\\\"term\\\":\\\"Blood Proteins\\\"},{\\\"id\\\":\\\"D011506\\\",\\\"term\\\":\\\"Proteins\\\"},{\\\"id\\\":\\\"D000602\\\",\\\"term\\\":\\\"Amino Acids, Peptides, and Proteins\\\"},{\\\"id\\\":\\\"D012712\\\",\\\"term\\\":\\\"Serum Globulins\\\"},{\\\"id\\\":\\\"D005916\\\",\\\"term\\\":\\\"Globulins\\\"},{\\\"id\\\":\\\"D056831\\\",\\\"term\\\":\\\"Coordination Complexes\\\"},{\\\"id\\\":\\\"D009930\\\",\\\"term\\\":\\\"Organic Chemicals\\\"},{\\\"id\\\":\\\"D006571\\\",\\\"term\\\":\\\"Heterocyclic Compounds\\\"},{\\\"id\\\":\\\"D003841\\\",\\\"term\\\":\\\"Deoxycytidine\\\"},{\\\"id\\\":\\\"D003562\\\",\\\"term\\\":\\\"Cytidine\\\"},{\\\"id\\\":\\\"D011741\\\",\\\"term\\\":\\\"Pyrimidine Nucleosides\\\"},{\\\"id\\\":\\\"D011743\\\",\\\"term\\\":\\\"Pyrimidines\\\"},{\\\"id\\\":\\\"D006573\\\",\\\"term\\\":\\\"Heterocyclic Compounds, 1-Ring\\\"},{\\\"id\\\":\\\"D043823\\\",\\\"term\\\":\\\"Taxoids\\\"},{\\\"id\\\":\\\"D043822\\\",\\\"term\\\":\\\"Cyclodecanes\\\"},{\\\"id\\\":\\\"D003516\\\",\\\"term\\\":\\\"Cycloparaffins\\\"},{\\\"id\\\":\\\"D006840\\\",\\\"term\\\":\\\"Hydrocarbons, Alicyclic\\\"},{\\\"id\\\":\\\"D006844\\\",\\\"term\\\":\\\"Hydrocarbons, Cyclic\\\"},{\\\"id\\\":\\\"D006838\\\",\\\"term\\\":\\\"Hydrocarbons\\\"},{\\\"id\\\":\\\"D004224\\\",\\\"term\\\":\\\"Diterpenes\\\"},{\\\"id\\\":\\\"D013729\\\",\\\"term\\\":\\\"Terpenes\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07804186\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"IDE196-011\\\"},\\\"organization\\\":{\\\"fullName\\\":\\\"IDEAYA Biosciences\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma\\\",\\\"officialTitle\\\":\\\"A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-08\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-09\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2034-03\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2034-04\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-08-21\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-08-31\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-09-04\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-08-31\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-09-04\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"IDEAYA Biosciences\\\",\\\"class\\\":\\\"INDUSTRY\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":true,\\\"isFdaRegulatedDevice\\\":false},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)\\\",\\\"detailedDescription\\\":\\\"This study will enroll participants who are at high-risk for metastatic disease and who have completed primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation) for their UM without evidence of active local or metastatic disease after this treatment.\\\\n\\\\nThe Treatment Arm will have participants who have completed PLT and will receive darovasertib + crizotinib.\\\\n\\\\nThe Observation Arm participants will not receive darovasertib + crizotinib but will be observed and followed for disease recurrence and survival (Control Arm)\\\\n\\\\nParticipants in both arms will be followed for up to five years to assess longer term outcomes such as tumor recurrence and survival.\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Uveal Melanoma\\\"],\\\"keywords\\\":[\\\"Uveal Melanoma\\\",\\\"plaque brachytherapy\\\",\\\"enucleation\\\",\\\"proton beam\\\",\\\"Adjuvant\\\",\\\"Darovasertib\\\",\\\"IDE 196\\\",\\\"Ocular Melanoma\\\",\\\"Choroidal Melanoma\\\",\\\"Ocular Oncology\\\",\\\"Protein Kinase C\\\",\\\"GNAQ\\\",\\\"GNA11\\\",\\\"Crizotinib\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"NONE\\\"}},\\\"enrollmentInfo\\\":{\\\"count\\\":450,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Treatment\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested\\\",\\\"interventionNames\\\":[\\\"Drug: Darovasertib\\\",\\\"Drug: Crizotinib (Xalkori)\\\"]},{\\\"label\\\":\\\"Observation\\\",\\\"type\\\":\\\"NO_INTERVENTION\\\",\\\"description\\\":\\\"Participant Group/Arm: Observation Standard of care observation \\\\\\\\\\u0026 follow-up (no treatment)\\\"}],\\\"interventions\\\":[{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Darovasertib\\\",\\\"description\\\":\\\"Oral, selectively targets key proteins\\\",\\\"armGroupLabels\\\":[\\\"Treatment\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Crizotinib (Xalkori)\\\",\\\"description\\\":\\\"Oral small molecule\\\",\\\"armGroupLabels\\\":[\\\"Treatment\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Median relapse-free survival\\\",\\\"description\\\":\\\"Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Median metastasis-free survival\\\",\\\"description\\\":\\\"Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) by BICR per RECIST v 1.1\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Overall survival\\\",\\\"description\\\":\\\"Overall survival with darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease who are at high-risk for recurrence\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Median UM specific survival\\\",\\\"description\\\":\\\"Median UM specific survival defined as the time from randomization to the date of death due to UM\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Median metastasis-free survival\\\",\\\"description\\\":\\\"Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) as assessed by investigator\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Safety, and severity of occurrence of adverse events (AEs) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V6.0 or later\\\",\\\"description\\\":\\\"To assess safety and tolerability of darovasertib + crizotinib in participants who have completed PLT for primary UM\\\",\\\"timeFrame\\\":\\\"Approximately 3 years\\\"},{\\\"measure\\\":\\\"Change from baseline over time and across Treatment Arms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30)\\\",\\\"description\\\":\\\"Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Recurrence-free suvival\\\",\\\"description\\\":\\\"Compare RFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Metastasis-Free Survival\\\",\\\"description\\\":\\\"Compare MFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Median Local Recurrence-Free Survival\\\",\\\"description\\\":\\\"Compare local RFS (LRFS) of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence\\\",\\\"timeFrame\\\":\\\"Approximately 5 years\\\"},{\\\"measure\\\":\\\"Change from baseline over time and across Treatment Arms as measured by European Quality of Life Questionnaire EQ-5D-5L.\\\",\\\"description\\\":\\\"Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM\\\",\\\"timeFrame\\\":\\\"[Time Frame: Approximately 5 years]\\\"},{\\\"measure\\\":\\\"Change from baseline over time and across Treatment Arms as measured by EORTC Oncology Quality of Life Questionnaire Ophthalmic-30 (EORTC QLQ-OPT30)\\\",\\\"description\\\":\\\"Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM\\\",\\\"timeFrame\\\":\\\"[Time Frame: Approximately 5 years]\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Inclusion Criteria:\\\\n\\\\n* Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3)\\\\n* Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy)\\\\n* ECOG performance status of 0 or 1\\\\n* Adequate organ function\\\\n* Age 18 or older\\\\n* Written informed consent and ability to comply\\\\n* Primary local therapy completed within 120 days before C1D1/randomization.\\\\n* Contraception requirements\\\\n\\\\nExclusion Criteria:\\\\n\\\\n* Previous systemic treatment for Uveal Melanoma\\\\n* Clinical or radiological evidence of metastatic UM\\\\n* Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin cancers, any malignancy considered to be indolent and never required systemic therapy, and any type of carcinoma in situ receiving curative therapy (resection)\\\\n* Known AIDS related illness\\\\n* History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids\\\\n* History of syncope may be exclusionary, but will be reviewed on a case-by-case basis\\\\n* Active Hepatitis B or C infection\\\\n* Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow\\\\n* Females who are pregnant or breastfeeding\\\\n* Impaired cardiac function\\\\n* History of stroke within the last 6 months of randomization\\\\n* Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib\\\\n* allergy to mammalian meat products or gelatin\\\",\\\"healthyVolunteers\\\":false,\\\"sex\\\":\\\"ALL\\\",\\\"minimumAge\\\":\\\"18 Years\\\",\\\"stdAges\\\":[\\\"ADULT\\\",\\\"OLDER_ADULT\\\"]},\\\"contactsLocationsModule\\\":{\\\"centralContacts\\\":[{\\\"name\\\":\\\"IDEAYA Clinical Trials\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"+1-855-433-2246\\\",\\\"email\\\":\\\"IDEAYAClinicalTrials@ideayabio.com\\\"},{\\\"name\\\":\\\"Holger Thurm\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"email\\\":\\\"hthurm@ideayabio.com\\\"}],\\\"locations\\\":[{\\\"facility\\\":\\\"Princess Margaret Cancer Centre\\\",\\\"status\\\":\\\"RECRUITING\\\",\\\"city\\\":\\\"Toronto\\\",\\\"state\\\":\\\"Ontario\\\",\\\"zip\\\":\\\"M5G 2M9\\\",\\\"country\\\":\\\"Canada\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Marcus Butler, MD\\\",\\\"role\\\":\\\"CONTACT\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":43.70643,\\\"lon\\\":-79.39864}}]},\\\"ipdSharingStatementModule\\\":{\\\"ipdSharing\\\":\\\"NO\\\"}},\\\"derivedSection\\\":{\\\"miscInfoModule\\\":{\\\"versionHolder\\\":\\\"2026-09-11\\\"},\\\"conditionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D000098943\\\",\\\"term\\\":\\\"Uveal Melanoma\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D008545\\\",\\\"term\\\":\\\"Melanoma\\\"},{\\\"id\\\":\\\"D018358\\\",\\\"term\\\":\\\"Neuroendocrine Tumors\\\"},{\\\"id\\\":\\\"D017599\\\",\\\"term\\\":\\\"Neuroectodermal Tumors\\\"},{\\\"id\\\":\\\"D009373\\\",\\\"term\\\":\\\"Neoplasms, Germ Cell and Embryonal\\\"},{\\\"id\\\":\\\"D009370\\\",\\\"term\\\":\\\"Neoplasms by Histologic Type\\\"},{\\\"id\\\":\\\"D009369\\\",\\\"term\\\":\\\"Neoplasms\\\"},{\\\"id\\\":\\\"D009380\\\",\\\"term\\\":\\\"Neoplasms, Nerve Tissue\\\"},{\\\"id\\\":\\\"D018326\\\",\\\"term\\\":\\\"Nevi and Melanomas\\\"},{\\\"id\\\":\\\"D014604\\\",\\\"term\\\":\\\"Uveal Neoplasms\\\"},{\\\"id\\\":\\\"D005134\\\",\\\"term\\\":\\\"Eye Neoplasms\\\"},{\\\"id\\\":\\\"D009371\\\",\\\"term\\\":\\\"Neoplasms by Site\\\"},{\\\"id\\\":\\\"D005128\\\",\\\"term\\\":\\\"Eye Diseases\\\"},{\\\"id\\\":\\\"D014603\\\",\\\"term\\\":\\\"Uveal Diseases\\\"}]},\\\"interventionBrowseModule\\\":{\\\"meshes\\\":[{\\\"id\\\":\\\"D000077547\\\",\\\"term\\\":\\\"Crizotinib\\\"}],\\\"ancestors\\\":[{\\\"id\\\":\\\"D010880\\\",\\\"term\\\":\\\"Piperidines\\\"},{\\\"id\\\":\\\"D006573\\\",\\\"term\\\":\\\"Heterocyclic Compounds, 1-Ring\\\"},{\\\"id\\\":\\\"D006571\\\",\\\"term\\\":\\\"Heterocyclic Compounds\\\"},{\\\"id\\\":\\\"D000631\\\",\\\"term\\\":\\\"Aminopyridines\\\"},{\\\"id\\\":\\\"D011725\\\",\\\"term\\\":\\\"Pyridines\\\"}]}},\\\"hasResults\\\":false},\\n{\\\"protocolSection\\\":{\\\"identificationModule\\\":{\\\"nctId\\\":\\\"NCT07623161\\\",\\\"orgStudyIdInfo\\\":{\\\"id\\\":\\\"TAK-226-3002\\\"},\\\"secondaryIdInfos\\\":[{\\\"id\\\":\\\"2026-525660-17-00\\\",\\\"type\\\":\\\"CTIS\\\"}],\\\"organization\\\":{\\\"fullName\\\":\\\"Takeda\\\",\\\"class\\\":\\\"INDUSTRY\\\"},\\\"briefTitle\\\":\\\"A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib\\\",\\\"officialTitle\\\":\\\"A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy\\\",\\\"acronym\\\":\\\"ELRISE MF\\\"},\\\"statusModule\\\":{\\\"statusVerifiedDate\\\":\\\"2026-08\\\",\\\"overallStatus\\\":\\\"RECRUITING\\\",\\\"expandedAccessInfo\\\":{\\\"hasExpandedAccess\\\":false},\\\"startDateStruct\\\":{\\\"date\\\":\\\"2026-09-02\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"primaryCompletionDateStruct\\\":{\\\"date\\\":\\\"2029-12-07\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"completionDateStruct\\\":{\\\"date\\\":\\\"2034-03-30\\\",\\\"type\\\":\\\"ESTIMATED\\\"},\\\"studyFirstSubmitDate\\\":\\\"2026-05-29\\\",\\\"studyFirstSubmitQcDate\\\":\\\"2026-05-29\\\",\\\"studyFirstPostDateStruct\\\":{\\\"date\\\":\\\"2026-06-03\\\",\\\"type\\\":\\\"ACTUAL\\\"},\\\"lastUpdateSubmitDate\\\":\\\"2026-08-20\\\",\\\"lastUpdatePostDateStruct\\\":{\\\"date\\\":\\\"2026-08-24\\\",\\\"type\\\":\\\"ACTUAL\\\"}},\\\"sponsorCollaboratorsModule\\\":{\\\"responsibleParty\\\":{\\\"type\\\":\\\"SPONSOR\\\"},\\\"leadSponsor\\\":{\\\"name\\\":\\\"Takeda\\\",\\\"class\\\":\\\"INDUSTRY\\\"}},\\\"oversightModule\\\":{\\\"oversightHasDmc\\\":true,\\\"isFdaRegulatedDrug\\\":true,\\\"isFdaRegulatedDevice\\\":false,\\\"isUsExport\\\":true},\\\"descriptionModule\\\":{\\\"briefSummary\\\":\\\"The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\\\\n\\\\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\\\\n\\\\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.\\\"},\\\"conditionsModule\\\":{\\\"conditions\\\":[\\\"Myelofibrosis\\\",\\\"Anemia\\\"],\\\"keywords\\\":[\\\"TAK-226\\\",\\\"Drug therapy\\\"]},\\\"designModule\\\":{\\\"studyType\\\":\\\"INTERVENTIONAL\\\",\\\"phases\\\":[\\\"PHASE3\\\"],\\\"designInfo\\\":{\\\"allocation\\\":\\\"RANDOMIZED\\\",\\\"interventionModel\\\":\\\"PARALLEL\\\",\\\"primaryPurpose\\\":\\\"TREATMENT\\\",\\\"maskingInfo\\\":{\\\"masking\\\":\\\"TRIPLE\\\",\\\"whoMasked\\\":[\\\"PARTICIPANT\\\",\\\"CARE_PROVIDER\\\",\\\"INVESTIGATOR\\\"]}},\\\"enrollmentInfo\\\":{\\\"count\\\":324,\\\"type\\\":\\\"ESTIMATED\\\"}},\\\"armsInterventionsModule\\\":{\\\"armGroups\\\":[{\\\"label\\\":\\\"Elritercept\\\",\\\"type\\\":\\\"EXPERIMENTAL\\\",\\\"description\\\":\\\"Participants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) subcutaneously (SC) once every 4 weeks (Q4W) on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period, with possible up-titration to 5.0 mg/kg from Cycle 3 Day 1 based on response and safety/tolerability. Participants may continue to receive elritercept during the extended open-label treatment period.\\\",\\\"interventionNames\\\":[\\\"Drug: Elritercept\\\"]},{\\\"label\\\":\\\"Placebo\\\",\\\"type\\\":\\\"PLACEBO_COMPARATOR\\\",\\\"description\\\":\\\"Participants will receive elritercept-matching placebo with equivalent volume to elritercept SC Q4W on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period. Eligible participants may initiate elritercept at a starting dose of 3.75 mg/kg SC Q4W on Day 1 of each 28-day cycle during the extended open-label treatment period, with possible up-titration to 5.0 mg/kg after 2 cycles, based on response and safety/tolerability.\\\",\\\"interventionNames\\\":[\\\"Drug: Placebo\\\",\\\"Drug: Elritercept\\\"]}],\\\"interventions\\\":[{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Placebo\\\",\\\"description\\\":\\\"Elritercept-matching placebo\\\",\\\"armGroupLabels\\\":[\\\"Placebo\\\"]},{\\\"type\\\":\\\"DRUG\\\",\\\"name\\\":\\\"Elritercept\\\",\\\"description\\\":\\\"Elritercept, SC, injection\\\",\\\"armGroupLabels\\\":[\\\"Elritercept\\\",\\\"Placebo\\\"],\\\"otherNames\\\":[\\\"TAK-226\\\"]}]},\\\"outcomesModule\\\":{\\\"primaryOutcomes\\\":[{\\\"measure\\\":\\\"Proportion of Participants Who Are Red Blood Cell-Transfusion Independent (RBC-TI) for Any Consecutive Greater Than or Equal to (≥) 12-Week Period During the 36-Week Double-Blinded Treatment Period\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"}],\\\"secondaryOutcomes\\\":[{\\\"measure\\\":\\\"Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive ≥16-Week Period\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hemoglobin (Hgb) Increase ≥1.5 Grams per Deciliter (g/dL) From Baseline\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive ≥24-Week Period\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hgb Increase of ≥1.0 g/dL and ≥2.0 g/dL From Baseline\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Are RBC-TI for Any Consecutive 16- or 24-Week Period With a Concurrent Mean Hgb Increase of ≥1.0 g/dL, ≥1.5 g/dL, and ≥2.0 g/dL From Baseline\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Maximum Duration of RBC-TI for Participants Who Achieved RBC-TI for a Consecutive ≥12 Weeks\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Maximum Duration of RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL for Participants Who Achieved Consecutive ≥12 Weeks RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL\\\",\\\"description\\\":\\\"RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Onset of Anemia Response\\\",\\\"description\\\":\\\"Time to onset of anemia response is defined as the duration between the date of randomization and the date participant first achieved anemia response status. Anemia response is evaluated as: achievement of RBC-TI for any consecutive ≥12-week, ≥16-week, or ≥24-week period or ≥50% reduction in red blood cell transfusion burden from baseline over any consecutive 12 weeks.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a T-Score at Week 36\\\",\\\"description\\\":\\\"PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service.\\\",\\\"timeFrame\\\":\\\"Baseline, Week 36\\\"},{\\\"measure\\\":\\\"Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue Scale Score at Week 36\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participants with cancer. The questionnaire's items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, and pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, and diarrhea) as well as financial difficulties, and a 2-item scale measuring global health status (GHS))/quality of life (QoL). Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, GHS/QoL, or worse symptomatology.\\\",\\\"timeFrame\\\":\\\"Baseline, Week 36\\\"},{\\\"measure\\\":\\\"Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-score\\\",\\\"description\\\":\\\"PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-Score From Baseline\\\",\\\"description\\\":\\\"PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score From Baseline\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Mean Changes From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 7-Item Total Symptom Score at Week 36\\\",\\\"description\\\":\\\"MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The Total Symptom Score (TSS) is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.\\\",\\\"timeFrame\\\":\\\"Baseline, Week 36\\\"},{\\\"measure\\\":\\\"Proportion of Participants Achieving Confirmed 50% Reduction in MFSAF v4.0 Total Symptom Score (TSS50)\\\",\\\"description\\\":\\\"MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Symptom Response in MFSAF TSS50 From Baseline\\\",\\\"description\\\":\\\"MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Mean Change From Baseline EORTC QLQ-C30 Physical Functioning Scale Score at Week 36\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning.\\\",\\\"timeFrame\\\":\\\"Baseline, Week 36\\\"},{\\\"measure\\\":\\\"Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score From Baseline\\\",\\\"description\\\":\\\"EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants With Platelet Response During the 36-Week Double-Blinded Treatment Period\\\",\\\"description\\\":\\\"Platelet response includes a mean increase of ≥30×10\\\\\\\\^9/ liter (L) from baseline, a \\\\\\\\\\u003e50% increase from baseline with a count ≥50×10\\\\\\\\^9/L, and conversion from \\\\\\\\\\u003c100 to ≥100×10\\\\\\\\^9/L, each sustained for ≥12 weeks.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Achieving Spleen Volume Reduction (SVR) From Baseline as Measured by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) During the 36-Week Double-Blinded Treatment Period\\\",\\\"description\\\":\\\"Proportion of participants achieving SVR of ≥10%, ≥25%, or ≥35% will be presented for this outcome measure.\\\",\\\"timeFrame\\\":\\\"From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Develop Accelerated Phase (AP) MF\\\",\\\"timeFrame\\\":\\\"Up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Time to Progression in Participants Who Develop AP MF\\\",\\\"timeFrame\\\":\\\"Up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Proportion of Participants Who Develop Blast Phase (BP) MF\\\",\\\"timeFrame\\\":\\\"Up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Time to Progression in Participants Who Develop BP MF\\\",\\\"timeFrame\\\":\\\"Up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Plasma Concentration-Time Data for Participants Treated With Elritercept\\\",\\\"timeFrame\\\":\\\"At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Proportion of Participants Treated With Elritercept who Have Antidrug Antibodies\\\",\\\"timeFrame\\\":\\\"At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years\\\"},{\\\"measure\\\":\\\"Overall Survival (OS)\\\",\\\"description\\\":\\\"OS is defined as the time from randomization to the date of death due to any cause.\\\",\\\"timeFrame\\\":\\\"From randomization to 7 years\\\"}]},\\\"eligibilityModule\\\":{\\\"eligibilityCriteria\\\":\\\"Inclusion Criteria:\\\\n\\\\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\\\\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\\\\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\\\\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\\\\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\\\\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\\\\n\\\\nExclusion Criteria:\\\\n\\\\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\\\\n2. Systemic treatment within 28 days before randomization with any of the following:\\\\n\\\\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\\\\n   2. erythropoiesis-stimulating agents.\\\\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\\\\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\\\\n   5. Hydroxyurea.\\\\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\\\\n   7. Interferon.\\\\n   8. Thrombopoietin receptor agonists.\\\\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\\\\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\\\\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\\\\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\\\\n6. Life expectancy \\\\\\\\\\u003c12 months per investigator's judgment.\\\\n7. Clinically significant cardiovascular disease, defined as:\\\\n\\\\n   1. New York Heart Association heart disease Class III or IV;\\\\n   2. Fridericia corrected QT interval \\\\\\\\\\u003e500 millisecond (ms) during screening;\\\\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\\\\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.\\\\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\\\\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\\\\n\\\\n    1. Basal or squamous cell carcinoma of the skin;\\\\n    2. Carcinoma in situ of the cervix;\\\\n    3. Carcinoma in situ of the breast; and/or\\\\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);\\\\n    5. Early papillary thyroid cancer (stage I \\\\\\\\[T1-T2, N0, M0\\\\\\\\]).\\\\n11. History of solid organ or bone marrow transplantation.\\\\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.\\\\n13. 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Donchev\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":42.69751,\\\"lon\\\":23.32415}},{\\\"facility\\\":\\\"Juravinski Cancer Centre\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Hamilton\\\",\\\"state\\\":\\\"Ontario\\\",\\\"zip\\\":\\\"L8V 5C2\\\",\\\"country\\\":\\\"Canada\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"905 387 9495\\\",\\\"email\\\":\\\"hillis@hhsc.ca\\\"},{\\\"name\\\":\\\"Hillis Christopher\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":43.25011,\\\"lon\\\":-79.84963}},{\\\"facility\\\":\\\"Princess Margaret Cancer Centre\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Toronto\\\",\\\"state\\\":\\\"Ontario\\\",\\\"zip\\\":\\\"M5G 2M9\\\",\\\"country\\\":\\\"Canada\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"4169464501\\\",\\\"email\\\":\\\"dawn.maze@uhn.ca\\\"},{\\\"name\\\":\\\"Dawn Maze\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":43.70643,\\\"lon\\\":-79.39864}},{\\\"facility\\\":\\\"Jewish General Hospital\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Montreal\\\",\\\"state\\\":\\\"Quebec\\\",\\\"zip\\\":\\\"H3T1E2\\\",\\\"country\\\":\\\"Canada\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"514-340-8222 ext 23293\\\",\\\"email\\\":\\\"shireen.sirhan@mail.mcgill.ca\\\"},{\\\"name\\\":\\\"Shireen Sirhan\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":45.50884,\\\"lon\\\":-73.58781}},{\\\"facility\\\":\\\"McGill University Health Center\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Montreal\\\",\\\"state\\\":\\\"Quebec\\\",\\\"zip\\\":\\\"H4A 3J1\\\",\\\"country\\\":\\\"Canada\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"5149341934\\\",\\\"email\\\":\\\"jonathan.how@muhc.mcgill.ca\\\"},{\\\"name\\\":\\\"Jonathan How\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":45.50884,\\\"lon\\\":-73.58781}},{\\\"facility\\\":\\\"Hospital Cliniico Regional de Concepcion Dr\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Concepción\\\",\\\"state\\\":\\\"Biobio\\\",\\\"zip\\\":\\\"4030000\\\",\\\"country\\\":\\\"Chile\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"56979883460\\\",\\\"email\\\":\\\"monalejomero@yahoo.es\\\"},{\\\"name\\\":\\\"Monica Romero\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":-36.82699,\\\"lon\\\":-73.04977}},{\\\"facility\\\":\\\"IC La Serena Research\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"La Serena\\\",\\\"state\\\":\\\"Coquimbo Region\\\",\\\"zip\\\":\\\"01697\\\",\\\"country\\\":\\\"Chile\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"945481789\\\",\\\"email\\\":\\\"cleiden.villegas@iclsr.cl\\\"},{\\\"name\\\":\\\"Cleiden Villegas\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":-29.90591,\\\"lon\\\":-71.25014}},{\\\"facility\\\":\\\"Icegclinic\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Santiago\\\",\\\"state\\\":\\\"La Florida\\\",\\\"zip\\\":\\\"8241479\\\",\\\"country\\\":\\\"Chile\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"56944347482\\\",\\\"email\\\":\\\"cavendano@icegclinic.com\\\"},{\\\"name\\\":\\\"Carlos Avendano\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":-33.45694,\\\"lon\\\":-70.64827}},{\\\"facility\\\":\\\"Immunocel\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Las Condes\\\",\\\"state\\\":\\\"Santiago Metropolitan\\\",\\\"zip\\\":\\\"7560908\\\",\\\"country\\\":\\\"Chile\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"997890202\\\",\\\"email\\\":\\\"aberkovits@inmunocel.com\\\"},{\\\"name\\\":\\\"Alejandro Berkovits\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":-33.41636,\\\"lon\\\":-70.56413}},{\\\"facility\\\":\\\"Centro de Oncologia de Precision\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Santiago\\\",\\\"state\\\":\\\"Santiago Metropolitan\\\",\\\"zip\\\":\\\"7850000\\\",\\\"country\\\":\\\"Chile\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"973794261\\\",\\\"email\\\":\\\"icorvalan@celerityclinical.cl\\\"},{\\\"name\\\":\\\"Ignacio Corvalan\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":-33.45694,\\\"lon\\\":-70.64827}},{\\\"facility\\\":\\\"Hospital Pablo Tobon Uribe\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Medellín\\\",\\\"state\\\":\\\"Antioquia\\\",\\\"zip\\\":\\\"0000000\\\",\\\"country\\\":\\\"Colombia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"3148905603\\\",\\\"email\\\":\\\"kennygalvez@gmail.com\\\"},{\\\"name\\\":\\\"Kenny Galvez\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":6.245,\\\"lon\\\":-75.57151}},{\\\"facility\\\":\\\"Clinica General del Norte De Barranquilla\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Barranquilla\\\",\\\"state\\\":\\\"Atlántico\\\",\\\"zip\\\":\\\"080002\\\",\\\"country\\\":\\\"Colombia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"3058130222\\\",\\\"email\\\":\\\"arturo.guzman@zentria.com.co\\\"},{\\\"name\\\":\\\"Arturo Guzman\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":10.96854,\\\"lon\\\":-74.78132}},{\\\"facility\\\":\\\"Los Cobos Medical Center\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Bogotá\\\",\\\"state\\\":\\\"Bogota D.C.\\\",\\\"zip\\\":\\\"110121\\\",\\\"country\\\":\\\"Colombia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"3015917907\\\",\\\"email\\\":\\\"jheremyreyesmd@gmail.com\\\"},{\\\"name\\\":\\\"Jheremy Reyes\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":4.60971,\\\"lon\\\":-74.08175}},{\\\"facility\\\":\\\"Funcacion santa Fe De Bogota\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Bogota\\\",\\\"state\\\":\\\"Cundinamarca\\\",\\\"zip\\\":\\\"11011\\\",\\\"country\\\":\\\"Colombia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"57 3118028204\\\",\\\"email\\\":\\\"claudia.agudelo@fsfb.org.co\\\"},{\\\"name\\\":\\\"Claudia Agudelo\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}]},{\\\"facility\\\":\\\"Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Brno\\\",\\\"state\\\":\\\"Czech Republic\\\",\\\"zip\\\":\\\"625 00\\\",\\\"country\\\":\\\"Czechia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"420532233642\\\",\\\"email\\\":\\\"Weinbergerova.Barbora@fnbrno.cz\\\"},{\\\"name\\\":\\\"Barbora Weinbergerova\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":49.19522,\\\"lon\\\":16.60796}},{\\\"facility\\\":\\\"Fakultni nemocnice Hradec Kralove\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Hradec Králové\\\",\\\"state\\\":\\\"CZ\\\",\\\"zip\\\":\\\"50005\\\",\\\"country\\\":\\\"Czechia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"420495833837\\\",\\\"email\\\":\\\"petra.belohlavkova@fnhk.cz\\\"},{\\\"name\\\":\\\"Petra Belohlavkova\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":50.20923,\\\"lon\\\":15.83277}},{\\\"facility\\\":\\\"Vseobecna fakultni nemocnice Praha\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Prague\\\",\\\"state\\\":\\\"CZ\\\",\\\"zip\\\":\\\"12808\\\",\\\"country\\\":\\\"Czechia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"224966209\\\",\\\"email\\\":\\\"anna.jonasova@vfn.cz\\\"},{\\\"name\\\":\\\"Anna Jonasova\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":50.08804,\\\"lon\\\":14.42076}},{\\\"facility\\\":\\\"Fakultni nemocnice Kralovske Vinohrady\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Prague\\\",\\\"zip\\\":\\\"134 00\\\",\\\"country\\\":\\\"Czechia\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"267162887\\\",\\\"email\\\":\\\"Olga.cerna@fnkv.cz\\\"},{\\\"name\\\":\\\"Olga Cerna\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":50.08804,\\\"lon\\\":14.42076}},{\\\"facility\\\":\\\"CHU de Nice\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Nice\\\",\\\"state\\\":\\\"Alpes Maritimes\\\",\\\"zip\\\":\\\"6002\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"492035558\\\",\\\"email\\\":\\\"loschi.m@chu-nice.fr\\\"},{\\\"name\\\":\\\"Michael Loschi\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":43.70313,\\\"lon\\\":7.26608}},{\\\"facility\\\":\\\"Centre Hospitalier Lyon Sud\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Pierre-Bénite\\\",\\\"state\\\":\\\"Auvergne-Rhône-Alpes\\\",\\\"zip\\\":\\\"69495\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"33478861323\\\",\\\"email\\\":\\\"vincent.alcazer@chu-lyon.fr\\\"},{\\\"name\\\":\\\"Vincent Alcazer\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":45.70359,\\\"lon\\\":4.82424}},{\\\"facility\\\":\\\"CHU de Strasbourg\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Strasbourg\\\",\\\"state\\\":\\\"Bas Rhin\\\",\\\"zip\\\":\\\"67200\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"03 68 76 73 01\\\",\\\"email\\\":\\\"shanti.ame@chru-strasbourg.fr\\\"},{\\\"name\\\":\\\"Shanti Ame\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":48.58392,\\\"lon\\\":7.74553}},{\\\"facility\\\":\\\"Institut Paoli Calmettes\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Marseille\\\",\\\"state\\\":\\\"Bouches-du-Rhone\\\",\\\"zip\\\":\\\"13009\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"33491223868\\\",\\\"email\\\":\\\"reyj@ipc.unicancer.fr\\\"},{\\\"name\\\":\\\"Jerome Rey\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":43.29695,\\\"lon\\\":5.38107}},{\\\"facility\\\":\\\"Centre Hospitalier Regional Universitaire Brest Hopital Morvan\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Brest\\\",\\\"state\\\":\\\"Finistere\\\",\\\"zip\\\":\\\"29609\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"33298223786\\\",\\\"email\\\":\\\"jean-christophe.ianotto@chu-brest.fr\\\"},{\\\"name\\\":\\\"Jean-Christophe Ianotto\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":48.39029,\\\"lon\\\":-4.48628}},{\\\"facility\\\":\\\"CHU de Bordeaux\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Pessac\\\",\\\"state\\\":\\\"Gironde\\\",\\\"zip\\\":\\\"33600\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"05 57 65 65 11\\\",\\\"email\\\":\\\"clemence.mediavilla@chu-bordeaux.fr\\\"},{\\\"name\\\":\\\"Clemence Mediavilla\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":44.80565,\\\"lon\\\":-0.6324}},{\\\"facility\\\":\\\"Centre Hospitalier Regional Universitaire de Lille\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Lille\\\",\\\"state\\\":\\\"Nord\\\",\\\"zip\\\":\\\"59037\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"3320445713\\\",\\\"email\\\":\\\"mathieu.wemeau@chu-lille.fr\\\"},{\\\"name\\\":\\\"Mathieu Wemeau\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":50.63391,\\\"lon\\\":3.05512}},{\\\"facility\\\":\\\"Assistance Publique Hopitaux de Paris\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Paris\\\",\\\"state\\\":\\\"Paris\\\",\\\"zip\\\":\\\"75015\\\",\\\"country\\\":\\\"France\\\",\\\"contacts\\\":[{\\\"name\\\":\\\"Site Contact\\\",\\\"role\\\":\\\"CONTACT\\\",\\\"phone\\\":\\\"33142385270\\\",\\\"email\\\":\\\"lina.benajiba@aphp.fr\\\"},{\\\"name\\\":\\\"Lina Benajiba\\\",\\\"role\\\":\\\"PRINCIPAL_INVESTIGATOR\\\"}],\\\"geoPoint\\\":{\\\"lat\\\":48.85341,\\\"lon\\\":2.3488}},{\\\"facility\\\":\\\"CHU de Poitiers\\\",\\\"status\\\":\\\"NOT_YET_RECRUITING\\\",\\\"city\\\":\\\"Poitiers\\\",\\\"state\\\":\\\"Vienne\\\",\\\"zip\\\":\\\"86021\\\",\\\"country\\\":\\\"\n[...truncated]",
  "error": "",
  "elapsed": 0.194912637
}

{
  "tool_name": "shell",
  "tool_input": {
    "command": "cd /workspace/work && python3 - <<'EOF'\nimport json\np=\"/workspace/.hark/tool-results/db7ac1d0-b403-47ab-becb-155c213d55ea/c52c3d05c1e36eb4899e725c19648a65c7ddcab79a9735588c7f2dde2fa53b53.txt\"\ndata=json.loads(json.load(open(p))[\"content\"])\nprint(data[\"totalCount\"], len(data[\"studies\"]))\nrows=[]\nfor s in data[\"studies\"]:\n    ps=s[\"protocolSection\"]\n    idm=ps[\"identificationModule\"]\n    st=ps[\"statusModule\"]\n    d=ps.get(\"designModule\",{})\n    arms=ps.get(\"armsInterventionsModule\",{})\n    cl=ps.get(\"contactsLocationsModule\",{})\n    locs=cl.get(\"locations\",[]) or []\n    countries=[]\n    for l in locs:\n        c=l.get(\"country\")\n        if c and c not in countries: countries.append(c)\n    rows.append(dict(\n      nct=idm[\"nctId\"],\n      title=idm[\"briefTitle\"],\n      start=st.get(\"startDateStruct\",{}).get(\"date\"),\n      cond=\"; \".join(ps.get(\"conditionsModule\",{}).get(\"conditions\",[])),\n      interv=\"; \".join(f\"{i.get('type')}: {i.get('name')}\" for i in arms.get(\"interventions\",[]) or []),\n      sponsor=ps.get(\"sponsorCollaboratorsModule\",{}).get(\"leadSponsor\",{}).get(\"name\"),\n      enroll=d.get(\"enrollmentInfo\",{}).get(\"count\"),\n      etype=d.get(\"enrollmentInfo\",{}).get(\"type\"),\n      nloc=len(locs),\n      sites=[f\"{l.get('facility')} ({l.get('city')}, {l.get('state','')} {l.get('country')})\" for l in locs[:6]],\n      countries=countries,\n    ))\nrows.sort(key=lambda r: r[\"start\"] or \"\", reverse=True)\njson.dump(rows, open(\"ct_p3.json\",\"w\"), indent=1)\nfor r in rows:\n    print(\"=\"*80)\n    for k,v in r.items(): print(k,\":\",v)\nEOF"
  },
  "dispatch_id": "toolu_bdrk_018bFmMiZKaQmHxUewQnXU5h",
  "parent_dispatch_id": "",
  "handle": "",
  "panel_kind": ""
}

{
  "tool_name": "shell",
  "dispatch_id": "toolu_bdrk_018bFmMiZKaQmHxUewQnXU5h",
  "status": "running",
  "result": null,
  "error": "",
  "elapsed": null,
  "fields": {
    "progress": {
      "message": "",
      "metadata": {
        "browser_chain": false,
        "command": "cd /workspace/work && python3 - <<'EOF'\nimport json\np=\"/workspace/.hark/tool-results/db7ac1d0-b403-4...",
        "phase": "starting"
      }
    },
    "status": "running",
    "updatedAt": 1789169517739
  }
}

{
  "tool_name": "shell",
  "dispatch_id": "toolu_bdrk_018bFmMiZKaQmHxUewQnXU5h",
  "status": "completed",
  "result": "44 44\n================================================================================\nnct : NCT07648264\ntitle : Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies\nstart : 2026-09-11\ncond : Secondary Immune Deficiency\ninterv : BIOLOGICAL: IgPro20\nsponsor : CSL Behring\nenroll : 63\netype : ESTIMATED\nnloc : 60\nsites : ['UC Irvine (Orange, California United States)', 'CBCI, Colorado Blood Cancer Institute (Denver, Colorado United States)', 'SSAK Partners (Coral Springs, Florida United States)', 'Mayo Clinic - Jacksonville (Jacksonville, Florida United States)', 'Indiana University Health Arnett, Inc. (Lafayette, Indiana United States)', 'Johns Hopkins Asthma & Allergy Center (Baltimore, Maryland United States)']\ncountries : ['United States', 'Belgium', 'Canada', 'Czechia', 'Denmark', 'France', 'Germany', 'Italy', 'Poland', 'Spain', 'United Kingdom']\n================================================================================\nnct : NCT07815665\ntitle : A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma\nstart : 2026-09-10\ncond : Metastatic Urothelial Carcinoma; Metastatic Urothelial Carcinoma (UC)\ninterv : DRUG: Ivonescimab Dose 1; DRUG: enfortumab vedotin (EV); DRUG: Pembrolizumab; DRUG: Ivonescimab Dose 2; DRUG: Ivonescimab RP3D\nsponsor : Summit Therapeutics\nenroll : 800\netype : ESTIMATED\nnloc : 7\nsites : ['Research Site (Phoenix, Arizona United States)', 'Research Site (Los Angeles, California United States)', 'Research Site (Washington D.C., District of Columbia United States)', 'Research Site (Jacksonville, Florida United States)', 'Research Site (Rochester, Minnesota United States)', 'Research Site (Nashville, Tennessee United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07738172\ntitle : Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer\nstart : 2026-09-08\ncond : Lung Neoplasms, Non-Small Cell Lung Cancer\ninterv : PROCEDURE: Primary Tumor Resection; DRUG: Osimertinib\nsponsor : National Taiwan University Hospital\nenroll : 154\netype : ESTIMATED\nnloc : 1\nsites : ['National Taiwan University Hospital (Taipei, Taipei City Taiwan)']\ncountries : ['Taiwan']\n================================================================================\nnct : NCT07623200\ntitle : A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia\nstart : 2026-09-08\ncond : Essential Thrombocythemia\ninterv : DRUG: INCA033989; DRUG: Best Available Treatment\nsponsor : Incyte Corporation\nenroll : 426\netype : ESTIMATED\nnloc : 177\nsites : ['Banner Md Anderson Cancer Center (Gilbert, Arizona United States)', 'The University of Arizona Cancer Center (Tucson, Arizona United States)', 'City of Hope Medical Center (Duarte, California United States)', 'Marin Cancer Care (Greenbrae, California United States)', 'University of California, Los Angeles Medical Center (Los Angeles, California United States)', 'Stanford Cancer Center (Palo Alto, California United States)']\ncountries : ['United States', 'Australia', 'Austria', 'Belgium', 'Canada', 'Czechia', 'France', 'Germany', 'Hungary', 'Italy', 'Japan', 'Netherlands', 'Norway', 'Poland', 'South Korea', 'Spain', 'Switzerland', 'United Kingdom']\n================================================================================\nnct : NCT07444450\ntitle : A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec\nstart : 2026-09-04\ncond : Muscular Atrophy, Spinal\ninterv : DRUG: Salanersen; PROCEDURE: Sham Procedure\nsponsor : Biogen\nenroll : 42\netype : ESTIMATED\nnloc : 1\nsites : ['Neurology Rare Disease Center (Flower Mound, Texas United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07772778\ntitle : Evaluation of a Disability-Focused Sexual and Reproductive Health Curriculum for Health Students in Tanzania\nstart : 2026-09-03\ncond : Sexual and Reproductive Health; Disability; Health Knowledge, Attitudes, Practice; Health Education\ninterv : BEHAVIORAL: Disability-Focused Sexual and Reproductive Health Curriculum\nsponsor : University of Minnesota\nenroll : 412\netype : ESTIMATED\nnloc : 1\nsites : ['Muhimbili University of Health and Allied Sciences (Dar es Salaam,  Tanzania)']\ncountries : ['Tanzania']\n================================================================================\nnct : NCT07807865\ntitle : A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)\nstart : 2026-09-03\ncond : Generalized Anxiety Disorder\ninterv : DRUG: ITI-1284\nsponsor : Intra-Cellular Therapies, Inc.\nenroll : 900\netype : ESTIMATED\nnloc : 1\nsites : ['CalNeuro Research (Los Angeles, California United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07623161\ntitle : A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib\nstart : 2026-09-02\ncond : Myelofibrosis; Anemia\ninterv : DRUG: Placebo; DRUG: Elritercept\nsponsor : Takeda\nenroll : 324\netype : ESTIMATED\nnloc : 195\nsites : ['Banner MD Anderson Cancer Center (Gilbert, Arizona United States)', 'Los Angeles Cancer Network (Glendale, California United States)', 'Cancer and Blood Specialty Clinic (Whittier, California United States)', 'MedStar Georgetown University Hospital (Washington D.C., District of Columbia United States)', 'Advanced Research, LLC (Coral Springs, Florida United States)', 'Bioresearch Partners (Miami, Florida United States)']\ncountries : ['United States', 'Argentina', 'Australia', 'Austria', 'Belgium', 'Brazil', 'Bulgaria', 'Canada', 'Chile', 'Colombia', 'Czechia', 'France', 'Germany', 'Greece', 'Hungary', 'India', 'Ireland', 'Israel', 'Italy', 'Japan', 'Malaysia', 'Mexico', 'Poland', 'Romania', 'Saudi Arabia', 'South Korea', 'Spain', 'Sweden', 'Taiwan', 'Turkey (Türkiye)', 'United Kingdom']\n================================================================================\nnct : NCT07724366\ntitle : A Clinical Trial of TQH3906 Capsules in Adult Patients With Moderate to Severe Plaque Psoriasis\nstart : 2026-09-02\ncond : Psoriasis\ninterv : DRUG: TQH3906 capsules; DRUG: Deucravacitinib tablets 6 mg; DRUG: TQH3906 Capsules placebo; DRUG: Deucravacitinib tablets placebo\nsponsor : Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.\nenroll : 400\netype : ESTIMATED\nnloc : 45\nsites : ['Peking University Third Hospital (Beijing, Beijing Municipality China)', 'The First Affiliated Hospital of Chongqing Medical University 。 (Chongqing, Chongqing Municipality China)', 'Chongqing Traditional Chinese Medicine Hospital (Chongqing, Chongqing Municipality China)', 'Dermatology Hospital of Southern Medical University (Guangzhou, Guangdong China)', \"Guangdong Provincial People's Hospital (Guangzhou, Guangdong China)\", \"Shenzhen Second People's Hospital (Shenzhen, Guangdong China)\"]\ncountries : ['China']\n================================================================================\nnct : NCT07679360\ntitle : A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer\nstart : 2026-09-02\ncond : Triple Negative Breast Cancer\ninterv : DRUG: Trastuzumab Rezetecan for Injection; DRUG: Adebrelimab Injection; DRUG: Capecitabine tablets; DRUG: Pembrolizumab injection\nsponsor : Suzhou Suncadia Biopharmaceuticals Co., Ltd.\nenroll : 1000\netype : ESTIMATED\nnloc : 1\nsites : ['Cancer Hospital of Chinese Academy of Medical Sciences (Beijing, Beijing Municipality China)']\ncountries : ['China']\n================================================================================\nnct : NCT07763808\ntitle : Surgical Treatment for Gingival Recessions After Orthodontic Treatment\nstart : 2026-09-01\ncond : Gingival Recessions, Generalized\ninterv : PROCEDURE: Coronally advanced flap and a de-epithelialized soft tissue graft; PROCEDURE: Coronally advanced flap and a subepithelial connective tissue graft; PROCEDURE: Coronally advanced flap and Mucoderm soft tissue collagen graft\nsponsor : Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors\nenroll : 75\netype : ESTIMATED\nnloc : 1\nsites : ['Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors (Baku,  Azerbaijan)']\ncountries : ['Azerbaijan']\n================================================================================\nnct : NCT07408128\ntitle : Partner4Exercise Study\nstart : 2026-09-01\ncond : Cancer\ninterv : BEHAVIORAL: Peer matching; BEHAVIORAL: Quailfied Exercise Professional (QEP) Support\nsponsor : McMaster University\nenroll : 183\netype : ESTIMATED\nnloc : 1\nsites : ['McMaster University (Hamilton, Ontario Canada)']\ncountries : ['Canada']\n================================================================================\nnct : NCT06934655\ntitle : Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth\nstart : 2026-09-01\ncond : Pediatric Obesity; Metabolic and Bariatric Surgery; Semaglutide\ninterv : DRUG: Semaglutide 2.4 mg\nsponsor : Children's Hospital Los Angeles\nenroll : 150\netype : ESTIMATED\nnloc : 1\nsites : [\"Children's Hospital Los Angeles (Los Angeles, California United States)\"]\ncountries : ['United States']\n================================================================================\nnct : NCT07016321\ntitle : Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)\nstart : 2026-09-01\ncond : Dengue\ninterv : DRUG: Emetine Hydrochloride 6mg; DRUG: Placebo; DRUG: Emetine Hydrochloride 12mg\nsponsor : Johns Hopkins University\nenroll : 600\netype : ESTIMATED\nnloc : 2\nsites : ['Johns Hopkins University, Division of Infectious Disease (Baltimore, Maryland United States)', 'Bharatpur Hospital (Bharatpur-10, Chitwan Nepal)']\ncountries : ['United States', 'Nepal']\n================================================================================\nnct : NCT07151417\ntitle : Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery.\nstart : 2026-09-01\ncond : Knee Osteoarthritis; Musculoskeletal Disease; Surgery\ninterv : DRUG: PAI; DRUG: PAI + steroid; DRUG: PAI + zilretta\nsponsor : Walter Reed National Military Medical Center\nenroll : 240\netype : ESTIMATED\nnloc : 1\nsites : ['Walter Reed National Military Medical Center (Bethesda, Maryland United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07623135\ntitle : Lumateperone for Late-Life Depression\nstart : 2026-09-01\ncond : Treatment Resistant Depression (TRD); Late Life Depression (LLD); Depression / Major Depressive Disorder\ninterv : DRUG: Lumateperone; DRUG: Placebo\nsponsor : Eric Lenze\nenroll : 100\netype : ESTIMATED\nnloc : 2\nsites : ['University of Arizona (Tucson, Arizona United States)', 'Washington University School of Medicine (St Louis, Missouri United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07225972\ntitle : Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone\nstart : 2026-09-01\ncond : CMV; AdV Infection; AdV Reactivation; Adenovirus; Cytomegalovirus Infections\ninterv : DRUG: Standard of Care Antiviral medications; BIOLOGICAL: Viral CTLs\nsponsor : New York Medical College\nenroll : 138\netype : ESTIMATED\nnloc : 2\nsites : ['New York Medical College (Valhalla, New York United States)', 'Medical College of Wisconsin (Milwaukee, Wisconsin United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07587242\ntitle : A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping\nstart : 2026-09-01\ncond : Muscular Dystrophies; Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy); Muscular Disorders, Atrophic; Muscular Disease; Musculoskeletal Diseases; Neuromuscular Diseases (NMD); Nervous System Diseases; Genetic Diseases; X-Linked; Hereditary; Neonatal Disease; Duchene Muscular Dystrophy; Congenital; DMD\ninterv : DRUG: AOC 1044; DRUG: Placebo\nsponsor : Avidity Biosciences, Inc.\nenroll : 70\netype : ESTIMATED\nnloc : 13\nsites : ['UZ Leuven (Leuven,  Belgium)', 'Centre Hospitalier Régional de la Citadelle (Liège,  Belgium)', 'AP-HP Hospital Armand-Trousseau (Paris,  France)', 'Universitaetsklinikum Essen (Essen,  Germany)', 'Universitaetsklinikum Heidelberg (Heidelberg,  Germany)', 'Klinikum der Ludwig-Maximilians-Universitaet Muenchen (München,  Germany)']\ncountries : ['Belgium', 'France', 'Germany', 'Italy', 'Spain', 'United Kingdom']\n================================================================================\nnct : NCT07686081\ntitle : Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis\nstart : 2026-09\ncond : Ulcerative Colitis (UC)\ninterv : DRUG: Ponesimod; DRUG: Placebo\nsponsor : Vanda Pharmaceuticals\nenroll : 150\netype : ESTIMATED\nnloc : 2\nsites : ['Vanda Investigational Site (Chula Vista, California United States)', 'Vanda Investigational Site (Nashville, Tennessee United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07804186\ntitle : Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma\nstart : 2026-09\ncond : Uveal Melanoma\ninterv : DRUG: Darovasertib; DRUG: Crizotinib (Xalkori)\nsponsor : IDEAYA Biosciences\nenroll : 450\netype : ESTIMATED\nnloc : 1\nsites : ['Princess Margaret Cancer Centre (Toronto, Ontario Canada)']\ncountries : ['Canada']\n================================================================================\nnct : NCT06778564\ntitle : Stratification and Treatment in Early Psychosis Study - ENHANCE\nstart : 2026-09\ncond : Psychosis; First Episode Psychosis; Psychotic Disorders; Psychotic Episode\ninterv : DRUG: CBD 100 mg/mL Oral Solution; OTHER: Placebo\nsponsor : University of Oxford\nenroll : 250\netype : ESTIMATED\nnloc : 17\nsites : ['MedUni Vienna (Vienna,  Austria)', 'University of Augsburg (Augsburg,  Germany)', 'Charité Universitätsmedizin (Berlin,  Germany)', 'University Hospital Cologne (Cologne,  Germany)', 'Ludwig-Maximilian-University Munich (Munich,  Germany)', 'National and Kapodistrian University of Athens (Athens,  Greece)']\ncountries : ['Austria', 'Germany', 'Greece', 'Israel', 'Italy', 'Netherlands', 'Spain', 'Switzerland', 'United Kingdom']\n================================================================================\nnct : NCT07570654\ntitle : Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder\nstart : 2026-09\ncond : PTSD - Post Traumatic Stress Disorder; PTSD; PTSD Symptoms; PTSD, Post Traumatic Stress Disorder\ninterv : DRUG: COMP360 psilocybin\nsponsor : COMPASS Pathways\nenroll : 300\netype : ESTIMATED\nnloc : 2\nsites : ['Florida (Orlando, Florida United States)', 'NY (New York, New York United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07776210\ntitle : Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)\nstart : 2026-09\ncond : oGVHD; Ocular Graft Versus Host Disease\ninterv : BIOLOGICAL: d-MAPPS™ Ophthalmic Solution; BIOLOGICAL: Matching vehicle control\nsponsor : Regenerative Ocular Immunobiologics LLC\nenroll : 30\netype : ESTIMATED\nnloc : 5\nsites : ['Beverly Hills Institute of Ophthalmology (Beverly Hills, California United States)', 'Beverly Hills Optometry (Beverly Hills, California United States)', 'Regenerative Ocular Immunobiologics, LLC. (Palm Harbor, Florida United States)', 'Eyewell, LLC. (Boston, Massachusetts United States)', 'BostonSight (Boston, Massachusetts United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07517133\ntitle : A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia\nstart : 2026-09\ncond : Non-Transfusion-dependent Alpha-Thalassemia; Non-Transfusion-dependent Beta-Thalassemia\ninterv : DRUG: Mitapivat; DRUG: Placebo Matching Mitapivat\nsponsor : Agios Pharmaceuticals, Inc.\nenroll : 45\netype : ESTIMATED\nnloc : 4\nsites : ['Stanford Medicine (Palo Alto, California United States)', 'Weill Cornell Medical College/ New York Presbyterian (New York, New York United States)', \"Children's Hospital of Philadelphia (Philadelphia, Pennsylvania United States)\", 'University of Texas Southwestern Medical Center (Dallas, Texas United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07506863\ntitle : A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)\nstart : 2026-09\ncond : Transfusion-dependent Alpha-Thalassemia; Transfusion-dependent Beta-Thalassemia\ninterv : DRUG: Mitapivat Matched Placebo; DRUG: Mitapivat\nsponsor : Agios Pharmaceuticals, Inc.\nenroll : 54\netype : ESTIMATED\nnloc : 3\nsites : ['Weill Cornell Medical College/ New York Presbyterian (New York, New York United States)', \"Children's Hospital of Philadelphia (Philadelphia, Pennsylvania United States)\", 'University of Texas Southwestern Medical Center (Dallas, Texas United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07540364\ntitle : A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)\nstart : 2026-09\ncond : Narcolepsy\ninterv : DRUG: Samelisant; DRUG: Placebo\nsponsor : Suven Life Sciences Limited\nenroll : 240\netype : ESTIMATED\nnloc : 1\nsites : ['Bogan Sleep Consultants (Columbia, South Carolina United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT04563520\ntitle : SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis\nstart : 2026-09\ncond : Hemophilia A\ninterv : DRUG: Emicizumab; DRUG: FEIBA; DRUG: rFVIIa\nsponsor : Emory University\nenroll : 5\netype : ESTIMATED\nnloc : 2\nsites : [\"Children's Healthcare of Atlanta (Atlanta, Georgia United States)\", 'Emory University Hospital (Atlanta, Georgia United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07285239\ntitle : Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma\nstart : 2026-09\ncond : Multiple Myeloma\ninterv : DRUG: Arm A: Belantamab Mafodotin; DRUG: Arm B: Daratumumab Hyaluronidase; DRUG: Bortezomib; DRUG: Lenalidomide; DRUG: Dexamethasone\nsponsor : PrECOG, LLC.\nenroll : 500\netype : ESTIMATED\nnloc : 1\nsites : ['Gundersen Lutheran (La Crosse, Wisconsin United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07809256\ntitle : A Prospective, Single-center, Non-randomized, Interventional Study on the Effectiveness and Safety of Combined Immunotargeted Therapy in Patients With Metastatic Non-small Cell Cancer With a RET Gene Translocation\nstart : 2026-09\ncond : NSCLC (Non-small Cell Lung Cancer)R\ninterv : COMBINATION_PRODUCT: lenvatinib pembrolizumab\nsponsor : EuroCityClinic LLC\nenroll : 15\netype : ESTIMATED\nnloc : 1\nsites : ['EuroCityClinic LLC (Saint Petersburg,  Russia)']\ncountries : ['Russia']\n================================================================================\nnct : NCT07594119\ntitle : Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures\nstart : 2026-09\ncond : Focal Seizure; Epilepsy; Focal Epilepsy\ninterv : DRUG: RAP-219; DRUG: RAP-219; OTHER: Placebo\nsponsor : Rapport Therapeutics Inc.\nenroll : 312\netype : ESTIMATED\nnloc : 11\nsites : ['Clinic for Neurology (Huntsville, Alabama United States)', 'Pillar Clinical Research (Bentonville, Arkansas United States)', 'Colorado Springs Neurological Associates (Colorado Springs, Colorado United States)', 'K2 Medical Research (Maitland, Florida United States)', 'Serenity Research Center, LLC (Miami, Florida United States)', 'Re:Cognition Health-Chicago (Chicago, Illinois United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07212998\ntitle : Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial\nstart : 2026-08-31\ncond : Burn Injury; Thermal Burn\ninterv : BIOLOGICAL: Plasma; BIOLOGICAL: Standard care\nsponsor : Jason Sperry\nenroll : 750\netype : ESTIMATED\nnloc : 1\nsites : ['University of Pittsburgh (Pittsburgh, Pennsylvania United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07768345\ntitle : A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Immunocompromised Adults\nstart : 2026-08-31\ncond : Respiratory Syncytial Virus (RSV)\ninterv : BIOLOGICAL: RSVpreF Vaccine\nsponsor : Pfizer\nenroll : 440\netype : ESTIMATED\nnloc : 5\nsites : ['Kaiser Foundation Hospital LAMC (Los Angeles, California United States)', 'Kaiser Permanente Los Angeles Medical center (Los Angeles, California United States)', 'Kaiser Permanente (Los Angeles, California United States)', 'The Hope Clinic of Emory University (Decatur, Georgia United States)', 'Rochester Clinical Research (Rochester, New York United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07778316\ntitle : Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)\nstart : 2026-08-31\ncond : Small Cell Lung Cancer\ninterv : DRUG: Tarlatamab\nsponsor : Amgen\nenroll : 400\netype : ESTIMATED\nnloc : 2\nsites : ['Cancer and Hematology Centers of Western Michigan (Grand Rapids, Michigan United States)', 'Shanghai Pulmonary Hospital (Shanghai,  China)']\ncountries : ['United States', 'China']\n================================================================================\nnct : NCT07493304\ntitle : Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers\nstart : 2026-08-31\ncond : Venous Thromboembolism (VTE)\ninterv : DRUG: REGN7508; DRUG: Apixaban\nsponsor : Regeneron Pharmaceuticals\nenroll : 1600\netype : ESTIMATED\nnloc : 6\nsites : ['Bioresearch Partner- Hialeah Hospital (Hialeah, Florida United States)', 'Memorial Sloan Kettering Cancer Center (New York, New York United States)', 'El Paso Medical Research Institute (Medresearch Inc) (El Paso, Texas United States)', 'Yongin Severance Hospital (Yongin-si, Gyeonggi-do South Korea)', 'Haeundae Paik Hospital (Pusan, Gyeongsangnam-do South Korea)', 'Severance Hospital (Seoul,  South Korea)']\ncountries : ['United States', 'South Korea']\n================================================================================\nnct : NCT07816185\ntitle : A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)\nstart : 2026-08-31\ncond : Pulmonary Hypertension; Interstitial Lung Disease; Vascular Diseases; Cardiovascular Diseases; Fibrosis\ninterv : DRUG: Mosliciguat; DRUG: Placebo; DEVICE: Dry Powder Inhaler\nsponsor : Pulmovant, Inc.\nenroll : 376\netype : ESTIMATED\nnloc : 3\nsites : ['Clinical Research Site (Kissimmee, Florida United States)', 'Clinical Research Site (Louisville, Kentucky United States)', 'Clinical Research Site (Bend, Oregon United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07743580\ntitle : A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease\nstart : 2026-08-31\ncond : SARS-CoV-2\ninterv : DRUG: Secutrelvir; DRUG: Placebo\nsponsor : Shionogi\nenroll : 2000\netype : ESTIMATED\nnloc : 34\nsites : ['Hope Clinical Trials - 3970 W Flagler St. (Coral Gables, Florida United States)', 'Continental Clinical Research, LLC (Miami, Florida United States)', 'Reed Medical Research (Miami, Florida United States)', 'Kendall South Medical Center Inc. (Miami, Florida United States)', 'Global Clinical Professionals (St. Petersburg, Florida United States)', 'New Tampa Health (Tampa, Florida United States)']\ncountries : ['United States', 'Bulgaria', 'Japan']\n================================================================================\nnct : NCT07796789\ntitle : Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for Chemoradiotherapy-Related Anorexia in Nasopharyngeal Carcinoma\nstart : 2026-08-30\ncond : Nasopharyngeal Cancinoma (NPC)\ninterv : DRUG: Nanocrystalline Megestrol Acetate Oral Suspension; DRUG: Placebo\nsponsor : Sun Yat-sen University\nenroll : 204\netype : ESTIMATED\nnloc : 3\nsites : ['Sun Yat-sen University Cancer Cente (Guangzhou, Guangdong China)', 'Hunan Cancer Hospital (Changsha,  China)', 'Fujian Cancer Hospital (Fuzhou,  China)']\ncountries : ['China']\n================================================================================\nnct : NCT07743983\ntitle : A Study of BGM0504 in Early T2DM With Obesity\nstart : 2026-08-30\ncond : Type 2 Diabetes (T2DM)\ninterv : DRUG: BGM0504; DRUG: semaglutide\nsponsor : BrightGene Bio-Medical Technology Co., Ltd.\nenroll : 372\netype : ESTIMATED\nnloc : 1\nsites : ['Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School） (Nanjing, Jiangsu China)']\ncountries : ['China']\n================================================================================\nnct : NCT07640789\ntitle : A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)\nstart : 2026-08-28\ncond : Non-small Cell Lung Cancer Stage III\ninterv : DRUG: BL-B01D1; DRUG: Osimertinib\nsponsor : Sichuan Baili Pharmaceutical Co., Ltd.\nenroll : 418\netype : ESTIMATED\nnloc : 1\nsites : ['Cancer Hospital of Shandong First Medical University (Jinan, Shandong China)']\ncountries : ['China']\n================================================================================\nnct : NCT07564141\ntitle : Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer\nstart : 2026-08-28\ncond : Platinum-Sensitive Ovarian Cancer; Ovarian Cancer\ninterv : BIOLOGICAL: Rina-S; DRUG: Bevacizumab; DRUG: Carboplatin; DRUG: Gemcitabine; DRUG: Paclitaxel; DRUG: PLD\nsponsor : Genmab\nenroll : 688\netype : ESTIMATED\nnloc : 2\nsites : ['Danbury Hospital (Danbury, Connecticut United States)', 'ProHealth Care Inc (Waukesha, Wisconsin United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT07676162\ntitle : A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer\nstart : 2026-08-28\ncond : Advanced Colorectal Cancer\ninterv : DRUG: SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab; DRUG: Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab\nsponsor : Suzhou Suncadia Biopharmaceuticals Co., Ltd.\nenroll : 300\netype : ESTIMATED\nnloc : 1\nsites : ['Beijing cancer Hospital (Beijing, Beijing Municipality China)']\ncountries : ['China']\n================================================================================\nnct : NCT07751133\ntitle : Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer\nstart : 2026-08-28\ncond : Prostate Cancer; mHSPC; mCRPC\ninterv : DRUG: Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy\nsponsor : University College, London\nenroll : 1500\netype : ESTIMATED\nnloc : 1\nsites : ['The Christie NHS Foundation Trust (Manchester,  United Kingdom)']\ncountries : ['United Kingdom']\n================================================================================\nnct : NCT07805954\ntitle : Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma\nstart : 2026-08-28\ncond : Pancreatic Cancer; Pancreatic Cancer Metastatic; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Adenocarcinoma Metastatic; Pancreatic Adenocarcinoma; Pancreatic Adenosquamous Carcinoma\ninterv : DRUG: daraxonrasib; DRUG: gemcitabine; DRUG: nab-paclitaxel; DRUG: zoldonrasib\nsponsor : Revolution Medicines, Inc.\nenroll : 400\netype : ESTIMATED\nnloc : 1\nsites : ['Moffitt Cancer Center (Tampa, Florida United States)']\ncountries : ['United States']\n================================================================================\nnct : NCT04990128\ntitle : Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis\nstart : 2026-08-28\ncond : Hip Osteoarthritis\ninterv : COMBINATION_PRODUCT: Aspire Needle + Emcyte PureBMC; DRUG: Triamcinolone\nsponsor : The Cleveland Clinic\nenroll : 100\netype : ESTIMATED\nnloc : 1\nsites : ['Cleveland Clinic Florida (Weston, Florida United States)']\ncountries : ['United States']\n",
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    "command": "cd /workspace/work && python3 - <<'EOF'\nimport json,csv\nrows=json.load(open(\"ct_p3.json\"))\nwith open(\"ct_phase3_recruiting_2026-08-28_to_09-11.csv\",\"w\",newline=\"\") as f:\n    w=csv.writer(f)\n    w.writerow([\"NCT\",\"Start\",\"Condition\",\"Intervention\",\"Sponsor\",\"Enrollment (est)\",\"Site count\",\"Countries\",\"Example sites\",\"URL\"])\n    for r in rows:\n        w.writerow([r[\"nct\"],r[\"start\"],r[\"cond\"],r[\"interv\"],r[\"sponsor\"],r[\"enroll\"],r[\"nloc\"],\", \".join(r[\"countries\"]),\"; \".join(r[\"sites\"]),f\"https://clinicaltrials.gov/study/{r['nct']}\"])\ndef loc(r):\n    cs=r[\"countries\"]\n    s=f\"{r['nloc']} site\" + (\"s\" if r[\"nloc\"]!=1 else \"\")\n    if len(cs)<=2: return s+\" (\"+\", \".join(cs)+\")\"\n    return s+f\" ({cs[0]} + {len(cs)-1} more countries)\"\nlines=[\"| Condition | Intervention | Sponsor | Enroll | Locations |\",\"|---|---|---|---|---|\"]\nfor r in rows:\n    lines.append(f\"| [{r['cond'].split(';')[0]}](https://clinicaltrials.gov/study/{r['nct']}) | {r['interv'].replace('DRUG: ','').replace('BIOLOGICAL: ','').replace('PROCEDURE: ','').replace('BEHAVIORAL: ','').replace('OTHER: ','').replace('DEVICE: ','').replace('COMBINATION_PRODUCT: ','')} | {r['sponsor']} | {r['enroll']} | {loc(r)} |\")\nopen(\"table.md\",\"w\").write(\"\\n\".join(lines))\nprint(\"\\n\".join(lines))\nEOF"
  },
  "dispatch_id": "toolu_bdrk_01NuLmWC7uz6PmCXXsgs94rj",
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        "command": "cd /workspace/work && python3 - <<'EOF'\nimport json,csv\nrows=json.load(open(\"ct_p3.json\"))\nwith open...",
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      }
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{
  "tool_name": "shell",
  "dispatch_id": "toolu_bdrk_01NuLmWC7uz6PmCXXsgs94rj",
  "status": "completed",
  "result": "| Condition | Intervention | Sponsor | Enroll | Locations |\n|---|---|---|---|---|\n| [Secondary Immune Deficiency](https://clinicaltrials.gov/study/NCT07648264) | IgPro20 | CSL Behring | 63 | 60 sites (United States + 10 more countries) |\n| [Metastatic Urothelial Carcinoma](https://clinicaltrials.gov/study/NCT07815665) | Ivonescimab Dose 1; enfortumab vedotin (EV); Pembrolizumab; Ivonescimab Dose 2; Ivonescimab RP3D | Summit Therapeutics | 800 | 7 sites (United States) |\n| [Lung Neoplasms, Non-Small Cell Lung Cancer](https://clinicaltrials.gov/study/NCT07738172) | Primary Tumor Resection; Osimertinib | National Taiwan University Hospital | 154 | 1 site (Taiwan) |\n| [Essential Thrombocythemia](https://clinicaltrials.gov/study/NCT07623200) | INCA033989; Best Available Treatment | Incyte Corporation | 426 | 177 sites (United States + 17 more countries) |\n| [Muscular Atrophy, Spinal](https://clinicaltrials.gov/study/NCT07444450) | Salanersen; Sham Procedure | Biogen | 42 | 1 site (United States) |\n| [Sexual and Reproductive Health](https://clinicaltrials.gov/study/NCT07772778) | Disability-Focused Sexual and Reproductive Health Curriculum | University of Minnesota | 412 | 1 site (Tanzania) |\n| [Generalized Anxiety Disorder](https://clinicaltrials.gov/study/NCT07807865) | ITI-1284 | Intra-Cellular Therapies, Inc. | 900 | 1 site (United States) |\n| [Myelofibrosis](https://clinicaltrials.gov/study/NCT07623161) | Placebo; Elritercept | Takeda | 324 | 195 sites (United States + 30 more countries) |\n| [Psoriasis](https://clinicaltrials.gov/study/NCT07724366) | TQH3906 capsules; Deucravacitinib tablets 6 mg; TQH3906 Capsules placebo; Deucravacitinib tablets placebo | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | 400 | 45 sites (China) |\n| [Triple Negative Breast Cancer](https://clinicaltrials.gov/study/NCT07679360) | Trastuzumab Rezetecan for Injection; Adebrelimab Injection; Capecitabine tablets; Pembrolizumab injection | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | 1000 | 1 site (China) |\n| [Gingival Recessions, Generalized](https://clinicaltrials.gov/study/NCT07763808) | Coronally advanced flap and a de-epithelialized soft tissue graft; Coronally advanced flap and a subepithelial connective tissue graft; Coronally advanced flap and Mucoderm soft tissue collagen graft | Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors | 75 | 1 site (Azerbaijan) |\n| [Cancer](https://clinicaltrials.gov/study/NCT07408128) | Peer matching; Quailfied Exercise Professional (QEP) Support | McMaster University | 183 | 1 site (Canada) |\n| [Pediatric Obesity](https://clinicaltrials.gov/study/NCT06934655) | Semaglutide 2.4 mg | Children's Hospital Los Angeles | 150 | 1 site (United States) |\n| [Dengue](https://clinicaltrials.gov/study/NCT07016321) | Emetine Hydrochloride 6mg; Placebo; Emetine Hydrochloride 12mg | Johns Hopkins University | 600 | 2 sites (United States, Nepal) |\n| [Knee Osteoarthritis](https://clinicaltrials.gov/study/NCT07151417) | PAI; PAI + steroid; PAI + zilretta | Walter Reed National Military Medical Center | 240 | 1 site (United States) |\n| [Treatment Resistant Depression (TRD)](https://clinicaltrials.gov/study/NCT07623135) | Lumateperone; Placebo | Eric Lenze | 100 | 2 sites (United States) |\n| [CMV](https://clinicaltrials.gov/study/NCT07225972) | Standard of Care Antiviral medications; Viral CTLs | New York Medical College | 138 | 2 sites (United States) |\n| [Muscular Dystrophies](https://clinicaltrials.gov/study/NCT07587242) | AOC 1044; Placebo | Avidity Biosciences, Inc. | 70 | 13 sites (Belgium + 5 more countries) |\n| [Ulcerative Colitis (UC)](https://clinicaltrials.gov/study/NCT07686081) | Ponesimod; Placebo | Vanda Pharmaceuticals | 150 | 2 sites (United States) |\n| [Uveal Melanoma](https://clinicaltrials.gov/study/NCT07804186) | Darovasertib; Crizotinib (Xalkori) | IDEAYA Biosciences | 450 | 1 site (Canada) |\n| [Psychosis](https://clinicaltrials.gov/study/NCT06778564) | CBD 100 mg/mL Oral Solution; Placebo | University of Oxford | 250 | 17 sites (Austria + 8 more countries) |\n| [PTSD - Post Traumatic Stress Disorder](https://clinicaltrials.gov/study/NCT07570654) | COMP360 psilocybin | COMPASS Pathways | 300 | 2 sites (United States) |\n| [oGVHD](https://clinicaltrials.gov/study/NCT07776210) | d-MAPPS™ Ophthalmic Solution; Matching vehicle control | Regenerative Ocular Immunobiologics LLC | 30 | 5 sites (United States) |\n| [Non-Transfusion-dependent Alpha-Thalassemia](https://clinicaltrials.gov/study/NCT07517133) | Mitapivat; Placebo Matching Mitapivat | Agios Pharmaceuticals, Inc. | 45 | 4 sites (United States) |\n| [Transfusion-dependent Alpha-Thalassemia](https://clinicaltrials.gov/study/NCT07506863) | Mitapivat Matched Placebo; Mitapivat | Agios Pharmaceuticals, Inc. | 54 | 3 sites (United States) |\n| [Narcolepsy](https://clinicaltrials.gov/study/NCT07540364) | Samelisant; Placebo | Suven Life Sciences Limited | 240 | 1 site (United States) |\n| [Hemophilia A](https://clinicaltrials.gov/study/NCT04563520) | Emicizumab; FEIBA; rFVIIa | Emory University | 5 | 2 sites (United States) |\n| [Multiple Myeloma](https://clinicaltrials.gov/study/NCT07285239) | Arm A: Belantamab Mafodotin; Arm B: Daratumumab Hyaluronidase; Bortezomib; Lenalidomide; Dexamethasone | PrECOG, LLC. | 500 | 1 site (United States) |\n| [NSCLC (Non-small Cell Lung Cancer)R](https://clinicaltrials.gov/study/NCT07809256) | lenvatinib pembrolizumab | EuroCityClinic LLC | 15 | 1 site (Russia) |\n| [Focal Seizure](https://clinicaltrials.gov/study/NCT07594119) | RAP-219; RAP-219; Placebo | Rapport Therapeutics Inc. | 312 | 11 sites (United States) |\n| [Burn Injury](https://clinicaltrials.gov/study/NCT07212998) | Plasma; Standard care | Jason Sperry | 750 | 1 site (United States) |\n| [Respiratory Syncytial Virus (RSV)](https://clinicaltrials.gov/study/NCT07768345) | RSVpreF Vaccine | Pfizer | 440 | 5 sites (United States) |\n| [Small Cell Lung Cancer](https://clinicaltrials.gov/study/NCT07778316) | Tarlatamab | Amgen | 400 | 2 sites (United States, China) |\n| [Venous Thromboembolism (VTE)](https://clinicaltrials.gov/study/NCT07493304) | REGN7508; Apixaban | Regeneron Pharmaceuticals | 1600 | 6 sites (United States, South Korea) |\n| [Pulmonary Hypertension](https://clinicaltrials.gov/study/NCT07816185) | Mosliciguat; Placebo; Dry Powder Inhaler | Pulmovant, Inc. | 376 | 3 sites (United States) |\n| [SARS-CoV-2](https://clinicaltrials.gov/study/NCT07743580) | Secutrelvir; Placebo | Shionogi | 2000 | 34 sites (United States + 2 more countries) |\n| [Nasopharyngeal Cancinoma (NPC)](https://clinicaltrials.gov/study/NCT07796789) | Nanocrystalline Megestrol Acetate Oral Suspension; Placebo | Sun Yat-sen University | 204 | 3 sites (China) |\n| [Type 2 Diabetes (T2DM)](https://clinicaltrials.gov/study/NCT07743983) | BGM0504; semaglutide | BrightGene Bio-Medical Technology Co., Ltd. | 372 | 1 site (China) |\n| [Non-small Cell Lung Cancer Stage III](https://clinicaltrials.gov/study/NCT07640789) | BL-B01D1; Osimertinib | Sichuan Baili Pharmaceutical Co., Ltd. | 418 | 1 site (China) |\n| [Platinum-Sensitive Ovarian Cancer](https://clinicaltrials.gov/study/NCT07564141) | Rina-S; Bevacizumab; Carboplatin; Gemcitabine; Paclitaxel; PLD | Genmab | 688 | 2 sites (United States) |\n| [Advanced Colorectal Cancer](https://clinicaltrials.gov/study/NCT07676162) | SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab; Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | 300 | 1 site (China) |\n| [Prostate Cancer](https://clinicaltrials.gov/study/NCT07751133) | Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy | University College, London | 1500 | 1 site (United Kingdom) |\n| [Pancreatic Cancer](https://clinicaltrials.gov/study/NCT07805954) | daraxonrasib; gemcitabine; nab-paclitaxel; zoldonrasib | Revolution Medicines, Inc. | 400 | 1 site (United States) |\n| [Hip Osteoarthritis](https://clinicaltrials.gov/study/NCT04990128) | Aspire Needle + Emcyte PureBMC; Triamcinolone | The Cleveland Clinic | 100 | 1 site (United States) |\n",
  "error": "",
  "elapsed": 0.140098132
}

{
  "tool_name": "upload_file",
  "tool_input": {
    "path": "/workspace/work/ct_phase3_recruiting_2026-08-28_to_09-11.csv"
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  "dispatch_id": "toolu_bdrk_01LGp9W78TBhySHLqU48Vhou",
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  "tool_name": "upload_file",
  "dispatch_id": "toolu_bdrk_01LGp9W78TBhySHLqU48Vhou",
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        "attachment_url": "s3://sessions/751170ae-b31c-4b8e-9173-87a3f8a9bd23/uploads/cacb957c-0df/ct_phase3_recruiting_2026-08-28_to_09-11.csv",
        "path": "ct_phase3_recruiting_2026-08-28_to_09-11.csv",
        "s3_key": "sessions/751170ae-b31c-4b8e-9173-87a3f8a9bd23/uploads/cacb957c-0df/ct_phase3_recruiting_2026-08-28_to_09-11.csv"
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    "message": "File displayed to the user.",
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{
  "tool_name": "send_message",
  "tool_input": {
    "final": true,
    "in_response_to": "5ba6007e",
    "message": "44 phase 3 interventional studies are recruiting with a start date between Aug 28 and Sep 11, 2026 (from the ClinicalTrials.gov API, status = Recruiting). Full detail with every site is in the CSV; here they are, newest start first. Enrollment figures are estimated targets.\n\n| Condition | Intervention | Sponsor | Enroll | Locations |\n|---|---|---|---|---|\n| [Secondary immune deficiency](https://clinicaltrials.gov/study/NCT07648264) | IgPro20 | CSL Behring | 63 | 60 sites, US + 10 countries |\n| [Metastatic urothelial carcinoma](https://clinicaltrials.gov/study/NCT07815665) | Ivonescimab + enfortumab vedotin vs pembrolizumab + EV | Summit Therapeutics | 800 | 7 sites, US |\n| [NSCLC, EGFR-mutant oligometastatic](https://clinicaltrials.gov/study/NCT07738172) | Osimertinib ± primary tumor resection | National Taiwan University Hospital | 154 | 1 site, Taiwan |\n| [Essential thrombocythemia](https://clinicaltrials.gov/study/NCT07623200) | INCA033989 vs best available treatment | Incyte | 426 | 177 sites, US + 17 countries |\n| [Spinal muscular atrophy](https://clinicaltrials.gov/study/NCT07444450) | Salanersen (BIIB115) vs sham | Biogen | 42 | 1 site, US |\n| [Sexual and reproductive health education](https://clinicaltrials.gov/study/NCT07772778) | Disability-focused SRH curriculum | University of Minnesota | 412 | 1 site, Tanzania |\n| [Generalized anxiety disorder](https://clinicaltrials.gov/study/NCT07807865) | ITI-1284 | Intra-Cellular Therapies | 900 | 1 site, US |\n| [Myelofibrosis with anemia](https://clinicaltrials.gov/study/NCT07623161) | Elritercept vs placebo | Takeda | 324 | 195 sites, US + 30 countries |\n| [Plaque psoriasis](https://clinicaltrials.gov/study/NCT07724366) | TQH3906 vs deucravacitinib | Chia Tai Tianqing | 400 | 45 sites, China |\n| [Triple negative breast cancer](https://clinicaltrials.gov/study/NCT07679360) | Trastuzumab rezetecan + adebrelimab | Suzhou Suncadia | 1000 | 1 site, China |\n| [Gingival recession](https://clinicaltrials.gov/study/NCT07763808) | Three graft techniques | Aziz Aliyev Institute | 75 | 1 site, Azerbaijan |\n| [Cancer (exercise support)](https://clinicaltrials.gov/study/NCT07408128) | Peer matching, exercise professional | McMaster University | 183 | 1 site, Canada |\n| [Pediatric obesity post-sleeve](https://clinicaltrials.gov/study/NCT06934655) | Semaglutide 2.4 mg | Children's Hospital Los Angeles | 150 | 1 site, US |\n| [Dengue](https://clinicaltrials.gov/study/NCT07016321) | Emetine HCl 6/12 mg vs placebo | Johns Hopkins | 600 | 2 sites, US + Nepal |\n| [Knee osteoarthritis surgery](https://clinicaltrials.gov/study/NCT07151417) | PAI ± steroid ± Zilretta | Walter Reed | 240 | 1 site, US |\n| [Late-life treatment-resistant depression](https://clinicaltrials.gov/study/NCT07623135) | Lumateperone vs placebo | Eric Lenze (WashU) | 100 | 2 sites, US |\n| [Refractory CMV/adenovirus infection](https://clinicaltrials.gov/study/NCT07225972) | Viral CTLs + standard care | New York Medical College | 138 | 2 sites, US |\n| [Duchenne muscular dystrophy (exon 44)](https://clinicaltrials.gov/study/NCT07587242) | AOC 1044 vs placebo | Avidity Biosciences | 70 | 13 sites, Europe |\n| [Ulcerative colitis](https://clinicaltrials.gov/study/NCT07686081) | Ponesimod vs placebo | Vanda Pharmaceuticals | 150 | 2 sites, US |\n| [Uveal melanoma, adjuvant](https://clinicaltrials.gov/study/NCT07804186) | Darovasertib + crizotinib | IDEAYA Biosciences | 450 | 1 site, Canada |\n| [First-episode psychosis](https://clinicaltrials.gov/study/NCT06778564) | CBD oral solution vs placebo | University of Oxford | 250 | 17 sites, 9 countries |\n| [PTSD](https://clinicaltrials.gov/study/NCT07570654) | COMP360 psilocybin | COMPASS Pathways | 300 | 2 sites, US |\n| [Ocular GVHD](https://clinicaltrials.gov/study/NCT07776210) | d-MAPPS ophthalmic solution | Regenerative Ocular Immunobiologics | 30 | 5 sites, US |\n| [Non-transfusion-dependent thalassemia](https://clinicaltrials.gov/study/NCT07517133) | Mitapivat vs placebo | Agios | 45 | 4 sites, US |\n| [Transfusion-dependent thalassemia](https://clinicaltrials.gov/study/NCT07506863) | Mitapivat vs placebo | Agios | 54 | 3 sites, US |\n| [Narcolepsy](https://clinicaltrials.gov/study/NCT07540364) | Samelisant vs placebo | Suven Life Sciences | 240 | 1 site, US |\n| [Hemophilia A](https://clinicaltrials.gov/study/NCT04563520) | Emicizumab, FEIBA, rFVIIa | Emory University | 5 | 2 sites, US |\n| [Newly diagnosed multiple myeloma](https://clinicaltrials.gov/study/NCT07285239) | Belantamab mafodotin or daratumumab + VRd | PrECOG | 500 | 1 site, US |\n| [RET-translocated NSCLC](https://clinicaltrials.gov/study/NCT07809256) | Lenvatinib + pembrolizumab | EuroCityClinic | 15 | 1 site, Russia |\n| [Focal seizures](https://clinicaltrials.gov/study/NCT07594119) | RAP-219 vs placebo | Rapport Therapeutics | 312 | 11 sites, US |\n| [Burn injury resuscitation](https://clinicaltrials.gov/study/NCT07212998) | Plasma vs standard care | Jason Sperry (Pittsburgh) | 750 | 1 site, US |\n| [RSV in immunocompromised adults](https://clinicaltrials.gov/study/NCT07768345) | RSVpreF revaccination | Pfizer | 440 | 5 sites, US |\n| [Extensive-stage small cell lung cancer](https://clinicaltrials.gov/study/NCT07778316) | Tarlatamab SC vs IV | Amgen | 400 | 2 sites, US + China |\n| [Cancer-associated VTE](https://clinicaltrials.gov/study/NCT07493304) | REGN7508 vs apixaban | Regeneron | 1600 | 6 sites, US + South Korea |\n| [Pulmonary hypertension with ILD](https://clinicaltrials.gov/study/NCT07816185) | Inhaled mosliciguat vs placebo | Pulmovant | 376 | 3 sites, US |\n| [COVID-19, high risk](https://clinicaltrials.gov/study/NCT07743580) | Secutrelvir vs placebo | Shionogi | 2000 | 34 sites, US, Bulgaria, Japan |\n| [Nasopharyngeal carcinoma anorexia](https://clinicaltrials.gov/study/NCT07796789) | Megestrol acetate vs placebo | Sun Yat-sen University | 204 | 3 sites, China |\n| [Early type 2 diabetes with obesity](https://clinicaltrials.gov/study/NCT07743983) | BGM0504 vs semaglutide | BrightGene | 372 | 1 site, China |\n| [Stage III EGFR-mutated NSCLC](https://clinicaltrials.gov/study/NCT07640789) | BL-B01D1 + osimertinib | Sichuan Baili | 418 | 1 site, China |\n| [Platinum-sensitive ovarian cancer](https://clinicaltrials.gov/study/NCT07564141) | Rina-S ± bevacizumab | Genmab | 688 | 2 sites, US |\n| [Advanced colorectal cancer](https://clinicaltrials.gov/study/NCT07676162) | SHR-A1811 + chemo + bevacizumab | Suzhou Suncadia | 300 | 1 site, China |\n| [Metastatic prostate cancer](https://clinicaltrials.gov/study/NCT07751133) | ARPI dose optimization | University College London | 1500 | 1 site, UK |\n| [KRAS G12D metastatic pancreatic cancer](https://clinicaltrials.gov/study/NCT07805954) | Zoldonrasib + daraxonrasib vs gem/nab-paclitaxel | Revolution Medicines | 400 | 1 site, US |\n| [Hip osteoarthritis](https://clinicaltrials.gov/study/NCT04990128) | Bone marrow aspirate concentrate vs triamcinolone | Cleveland Clinic | 100 | 1 site, US |\n"
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