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
Summit Therapeutics
Summary
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years old at the time of enrollment * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1 * Expected life expectancy ≥ 3 months * Metastatic (Stage IV) NSCLC * Histologically or cytologically confirmed squamous or non-squamous NSCLC * Tumor demonstrates high PD-L1 expression ( TPS\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities. * At least one measurable noncerebral lesion according to RECIST 1.1 * No prior systemic treatment for metastatic NSCLC. Exclusion Criteria: * Hist…
Interventions
- BiologicalIvonescimab Injection
Subject will receive ivonescimab as an IV injection
- BiologicalPembrolizumab Injection
Subject will receive Pembrolizumab as an IV injection
Locations (202)
- Clinical Study SiteChandler, Arizona
- Clinical Study SitePhoenix, Arizona
- Clinical Study SiteHot Springs, Arkansas
- Clinical Study SiteCerritos, California
- Clinical Study SiteGlendale, California
- Clinical Study SiteIrvine, California