[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Summit Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100610534","phase-3-phase-iii-study-of-ivonescimab-or-bevacizumab-combined-with-folfox-in-patients-with-metastatic-colorectal-cancer-100610534",false,"NCT07228832","Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer","A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer","HARMONi-GI3","Inclusion Criteria:\n\n1. ECOG performance status score of 0 or 1\n2. Expected life expectancy ≥ 6 months\n3. Patients with histologically or cytologically confirmed metastatic CRC\n4. No prior systemic therapy for metastatic CRC\n5. At least 1 measurable noncerebral lesion\n\nExclusion Criteria:\n\n1. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease\n2. Known BRAF V600E mutant status\n3. Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction\n4. Ascites requiring paracentesis within last 30 days\n5. Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer\n6. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n7. Resectable disease","ALL","18 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)",[27],"Metastatic Colorectal Cancer (CRC)",[29,30],"mCRC","Ivonescimab","RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2025-11-18",{"date":39,"type":21},"2029-11-30",{"name":41,"class":42},"Summit Therapeutics","INDUSTRY",130,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100508375","phase-3-clinical-study-of-ivonescimab-for-first-line-treatment-of-metastatic-nsclc-patients-100508375","NCT05899608","Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients","A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3)","Inclusion Criteria:\n\n* Age ≥ 18 years old at the time of enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Expected life expectancy ≥ 3 months\n* Metastatic (Stage IV) NSCLC\n* Histologically or cytologically confirmed squamous or non-squamous NSCLC\n* Recorded measurement of the Tumor Proportion Score (TPS) or Tumor Cells (TC) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization\n* At least one measurable noncerebral lesion according to RECIST 1.1\n* No prior systemic treatment for metastatic NSCLC\n\nExclusion Criteria:\n\n* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma\n* Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.\n\n  * For non-squamous histology patients, actionable driver mutation testing results are required before randomization.\n* Has received any prior therapy for NSCLC in the metastatic setting\n* Tumor invasion, encasement of organs (e.g. pericardium, heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.",{"count":52,"type":21},1600,[24],"This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.",[56],"Non-Small Cell Lung Cancer","2026-04-24",{"date":59,"type":35},"2026-04-30",{"date":61,"type":35},"2023-10-26",{"date":63,"type":21},"2029-12-31",{"name":41,"class":42},253,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100575071","phase-3-clinical-study-of-ivonescimab-for-first-line-treatment-of-metastatic-nsclc-patients-with-high-pd-l1-100575071","NCT06767514","Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1","A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression","HARMONi-7","Inclusion Criteria:\n\n* Age ≥ 18 years old at the time of enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1\n* Expected life expectancy ≥ 3 months\n* Metastatic (Stage IV) NSCLC\n* Histologically or cytologically confirmed squamous or non-squamous NSCLC\n* Tumor demonstrates high PD-L1 expression ( TPS\\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved \u002F cleared by local health authorities.\n* At least one measurable noncerebral lesion according to RECIST 1.1\n* No prior systemic treatment for metastatic NSCLC.\n\nExclusion Criteria:\n\n* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.\n* Has received any prior therapy for NSCLC in the metastatic setting.\n* Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.\n* Known actionable genomic alterations for which first-line approved therapies are indicated\n* Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease\n* Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization\n* Active autoimmune or lung disease requiring systemic therapy\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5\n* Severe infection within 4 weeks prior to randomization\n* Major surgical procedures or serious trauma within 4 weeks prior to randomization\n* History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease",{"count":75,"type":21},780,[24],"Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.",[56],"2026-02-20",{"date":81,"type":35},"2026-02-24",{"date":83,"type":35},"2025-02-27",{"date":85,"type":21},"2029-06",{"name":41,"class":42},202,""]