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

Recruiting now · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05899608

Run by

Summit Therapeutics

People needed

1600

Starts

2023-10-26

Expected to finish

2029-12-31

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• TMC Healthcare — Tucson, Arizona, United States (enrolling)
• Genesis Cancer and Blood Institute — Hot Springs, Arkansas, United States (enrolling)
• University of Arkansas — Little Rock, Arkansas, United States (enrolling)
• LA Cancer Network — Anaheim, California, United States (enrolling)
• The Oncology Institute of Hope & Innovation — Cerritos, California, United States (enrolling)
• University of Southern California (USC) — Los Angeles, California, United States (enrolling)
• Cedar Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• Sutter Institute for Medical Research — Sacramento, California, United States (enrolling)
• UC Davis Medical Center — Sacramento, California, United States (enrolling)
• University of California Los Angeles (UCLA) — Santa Monica, California, United States (enrolling)
• Providence Medical Foundation — Santa Rosa, California, United States (enrolling)
• Kaiser Permanente — Vallejo, California, United States (enrolling)
• Rocky Mountain Cancer — Lone Tree, Colorado, United States (enrolling)
• Banner MD Anderson Cancer Center at North Colorado Medical Center — Loveland, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Florida Cancer Specialists & Research Institute (FCS)-East — Fort Myers, Florida, United States (enrolling)
• BioResearch Partner- Hialeah Hospital — Hialeah, Florida, United States (enrolling)
• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Cancer Specialists of North Florida — Jacksonville, Florida, United States (enrolling)
• Ocala Oncology — Ocala, Florida, United States (enrolling)
• Cancer Care of Brevard — Palm Bay, Florida, United States (enrolling)
• Memorial Cancer Institute — Pembroke Pines, Florida, United States (enrolling)
• Banner University Medical Center — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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