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

a study on Lung Cancer Non-Small Cell Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3)

Details

This study consists of two distinct NSCLC histology cohorts: squamous (N=600) and non-squamous (N=1000), approximately 1600 patients in total. Within each cohort, subjects are randomized in a 1:1 ratio into one of two treatment groups, receiving either ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The two histology cohorts will be analyzed independently

Keywords

Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, pembrolizumab, Ivonescimab Injection, Pembrolizumab Injection, Ivonescimab and chemotherapy, Pembrolizumab and chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T 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.

Locations

  • University of California Los Angeles (UCLA) accepting new patients
    Santa Monica California 90404 United States
  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • Cedar Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • University of Southern California (USC) accepting new patients
    Los Angeles California 90033 United States
  • The Oncology Institute of Hope & Innovation accepting new patients
    Cerritos California 90703 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Summit Therapeutics
Links
Sign up for this study
ID
NCT05899608
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1600 study participants
Last Updated
Contact us about this trial