Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
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.
Checked against the public recordLast updated Aug 24, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Summit Therapeutics
- Interventions being studied
- Biological: Ivonescimab Injection; Biological: Pembrolizumab Injection
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Age ≥ 18 years old at the time of enrollment * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Expected life expectancy ≥ 3 months * Metastatic (Stage IV) NSCLC * Histologically or cytologically confirmed squamous or non-squamous NSCLC * 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 * At least one measurable noncerebral lesion according to RECIST 1.1 * No prior systemic treatment for metastatic NSCLC Exclusion Criteria: * Histologic or cytopathologic evidence of the presence of small cell lung carcinoma * Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available. * For non-squamous histology patients, actionable driver mutation testing results are required before randomization. * Has received any prior therapy for NSCLC in the metastatic setting * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Banner University Medical CenterPhoenix, Arizona
- TMC HealthcareTucson, Arizona
- Genesis Cancer and Blood InstituteHot Springs, Arkansas
- University of ArkansasLittle Rock, Arkansas
- LA Cancer NetworkAnaheim, California
- The Oncology Institute of Hope & InnovationCerritos, California
- University of Southern California (USC)Los Angeles, California
- Cedar Sinai Medical CenterLos Angeles, California
- Valkyrie Clinical TrialsLos Angeles, California
- Sutter Institute for Medical ResearchSacramento, California
- UC Davis Medical CenterSacramento, California
- University of California Los Angeles (UCLA)Santa Monica, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 24, 2026. Always confirm current availability with the study team.