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Active, not recruiting Phase 3

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

NCT05899608 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2023-10-26
Last updated
2026-10-08

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Ivonescimab Injection →Pembrolizumab 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)

  • Overall Survival (OS) — approximately 4 years
    Overall Survival (OS) in the ITT population
  • Progression Free Survival (PFS) — approximately 3 years
    Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1

Trial sites (260)

FacilityCityRegionStatus
Banner University Medical Center Phoenix Arizona
TMC Healthcare Tucson Arizona
Genesis Cancer and Blood Institute Hot Springs Arkansas
University of Arkansas Little Rock Arkansas
LA Cancer Network Anaheim California
The Oncology Institute of Hope & Innovation Cerritos California
University of Southern California (USC) Los Angeles California
Cedar Sinai Medical Center Los Angeles California
Valkyrie Clinical Trials Los Angeles California
Sutter Institute for Medical Research Sacramento California
UC Davis Medical Center Sacramento California
University of California Los Angeles (UCLA) Santa Monica California
Providence Medical Foundation Santa Rosa California
Kaiser Permanente Vallejo California
Rocky Mountain Cancer Lone Tree Colorado
Banner MD Anderson Cancer Center at North Colorado Medical Center Loveland Colorado
Hartford Hospital Hartford Connecticut
Yale University New Haven Connecticut
Florida Cancer Specialists & Research Institute (FCS)-East Fort Myers Florida
BioResearch Partner- Hialeah Hospital Hialeah Florida
Memorial Healthcare System Hollywood Florida
Mayo Clinic Jacksonville Florida
Cancer Specialists of North Florida Jacksonville Florida
Ocala Oncology Ocala Florida
Cancer Care of Brevard Palm Bay Florida
Ascension Sacred Heart Health System Pensacola Florida
Exigent Network Petersburg Florida
BRCR Medical Center Inc Plantation Florida
Florida Cancer Specialists & Research Institute (FCS) - North St. Petersburg Florida
BRCR Medical Center Inc. Tamarac Florida
Florida Cancer Specialists & Research Institute (FCS)-South West Palm Beach Florida
Central Georgia Cancer Care Macon Georgia
Northwestern Memorial Hospital Chicago Illinois
Illinois Cancer Care P.C. Peoria Illinois
University of Kansas Cancer Center Westwood Kansas
Baptist Health Lexington Kentucky
Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
Ascension Saint Agnes Hospital Baltimore Maryland
Lahey Hospital Burlington Massachusetts
University of Michigan Ann Arbor Michigan

+ 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 UK