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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Banner University Medical Center, Phoenix, Arizona, United States
• TMC Healthcare, Tucson, Arizona, United States
• Genesis Cancer and Blood Institute, Hot Springs, Arkansas, United States
• University of Arkansas, Little Rock, Arkansas, United States
• LA Cancer Network, Anaheim, California, United States
• The Oncology Institute of Hope & Innovation, Cerritos, California, United States
• University of Southern California (USC), Los Angeles, California, United States
• Cedar Sinai Medical Center, Los Angeles, California, United States
• Valkyrie Clinical Trials, Los Angeles, California, United States
• Sutter Institute for Medical Research, Sacramento, California, United States
• UC Davis Medical Center, Sacramento, California, United States
• University of California Los Angeles (UCLA), Santa Monica, California, United States

+ 241 more sites.

Who to contact

Summit Clinical Trial Information · 1-833-256-0522 · medicalinformation@smmttx.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05899608.