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Clinical Trials in the USA / NCT05899608
Recruiting Phase 3

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

NCT05899608 · tracked via the Priya Life Science USA tracker
Sponsor
Summit Therapeutics
Phase
Phase 3
Started
2023-10-26
Last updated
2026-08-24

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Ivonescimab InjectionPembrolizumab Injection

Ivonescimab Injection: Subject will receive ivonescimab and chemotherapy as an IV injection

Pembrolizumab Injection: Subject will receive pembrolizumab and chemotherapy as an IV injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (260)

FacilityCityRegionStatus
Banner University Medical Center Phoenix Arizona Active Not Recruiting
TMC Healthcare Tucson Arizona Active Not Recruiting
Genesis Cancer and Blood Institute Hot Springs Arkansas Active Not Recruiting
University of Arkansas Little Rock Arkansas Active Not Recruiting
LA Cancer Network Anaheim California Active Not Recruiting
The Oncology Institute of Hope & Innovation Cerritos California Active Not Recruiting
University of Southern California (USC) Los Angeles California Active Not Recruiting
Cedar Sinai Medical Center Los Angeles California Active Not Recruiting
Valkyrie Clinical Trials Los Angeles California Active Not Recruiting
Sutter Institute for Medical Research Sacramento California Active Not Recruiting
UC Davis Medical Center Sacramento California Active Not Recruiting
University of California Los Angeles (UCLA) Santa Monica California Active Not Recruiting
Providence Medical Foundation Santa Rosa California Active Not Recruiting
Kaiser Permanente Vallejo California Active Not Recruiting
Rocky Mountain Cancer Lone Tree Colorado Active Not Recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center Loveland Colorado Active Not Recruiting
Hartford Hospital Hartford Connecticut Active Not Recruiting
Yale University New Haven Connecticut Active Not Recruiting
Florida Cancer Specialists & Research Institute (FCS)-East Fort Myers Florida Active Not Recruiting
BioResearch Partner- Hialeah Hospital Hialeah Florida Active Not Recruiting
Memorial Healthcare System Hollywood Florida Active Not Recruiting
Mayo Clinic Jacksonville Florida Active Not Recruiting
Cancer Specialists of North Florida Jacksonville Florida Active Not Recruiting
Ocala Oncology Ocala Florida Active Not Recruiting
Cancer Care of Brevard Palm Bay Florida Active Not Recruiting
Ascension Sacred Heart Health System Pensacola Florida Active Not Recruiting
Exigent Network Petersburg Florida Active Not Recruiting
BRCR Medical Center Inc Plantation Florida Active Not Recruiting
Florida Cancer Specialists & Research Institute (FCS) - North St. Petersburg Florida Active Not Recruiting
BRCR Medical Center Inc. Tamarac Florida Active Not Recruiting
Florida Cancer Specialists & Research Institute (FCS)-South West Palm Beach Florida Active Not Recruiting
Central Georgia Cancer Care Macon Georgia Active Not Recruiting
Northwestern Memorial Hospital Chicago Illinois Active Not Recruiting
Illinois Cancer Care P.C. Peoria Illinois Active Not Recruiting
University of Kansas Cancer Center Westwood Kansas Active Not Recruiting
Baptist Health Lexington Kentucky Active Not Recruiting
Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland Active Not Recruiting
Ascension Saint Agnes Hospital Baltimore Maryland Active Not Recruiting
Lahey Hospital Burlington Massachusetts Active Not Recruiting
University of Michigan Ann Arbor Michigan Active Not Recruiting

+ 220 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05899608 on ClinicalTrials.gov ↗ ← All trials in the USA