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4BX",{"type":52,"coordinates":2210},[2211,2212],-2.23743,53.48095,{"lat":2212,"lon":2211},{"type":2215,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100508375","phase-3-clinical-study-of-ivonescimab-for-first-line-treatment-of-metastatic-nsclc-patients-100508375",false,"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.","ALL","18 Years",{"count":2226,"type":2227},1600,"ESTIMATED","INTERVENTIONAL",[2230],"PHASE3","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.",[2233],"Non-Small Cell Lung Cancer","2026-04-24",{"date":2236,"type":2237},"2026-04-30","ACTUAL",{"date":2239,"type":2237},"2023-10-26",{"date":2241,"type":2227},"2029-12-31",{"name":5,"class":6},253]