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 UC Davis UCLA
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

The study will enroll approximately 1080 patients randomized in a 1:1 ratio for ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The study will enroll 45-50% of patients with NSCLC squamous histology and 50-55 % of patients with NSCLC non-squamous histology.

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) 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. heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.

Locations

  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • 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
  • LA Cancer Network accepting new patients
    Anaheim California 92801 United States
  • Sutter Institute for Medical Research accepting new patients
    Sacramento California 95816 United States
  • The Oncology Institute of Hope & Innovation accepting new patients
    Cerritos California 90703 United States
  • Kaiser Permanente accepting new patients
    Vallejo California 94589 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Summit Therapeutics
ID
NCT05899608
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1080 study participants
Last Updated
Contact us about this trial