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

Description

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.

Conditions

Non-Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Tucson

Summit Therapeutics Research Center, Tucson, Arizona, United States, 85711

Little Rock

Summit Therapeutics Research Center, Little Rock, Arkansas, United States, 72205

Los Angeles

Summit Therapeutics Research Center, Los Angeles, California, United States, 90033

Los Angeles

Summit Therapeutics Research Center, Los Angeles, California, United States, 90067

Sacramento

Summit Therapeutics Research Center, Sacramento, California, United States, 95817

Santa Monica

Summit Therapeutics Research Center, Santa Monica, California, United States, 90404

Santa Rosa

Summit Therapeutics Research Center, Santa Rosa, California, United States, 95403

Lone Tree

Summit Therapeutics Research Center, Lone Tree, Colorado, United States, 80124

Fort Myers

Summit Therapeutics Research Center, Fort Myers, Florida, United States, 33901

Jacksonville

Summit Therapeutics Research Center, Jacksonville, Florida, United States, 32256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Tumor Proportion Score (TPS) with PD-L1 expression prior to randomization
  • * At least one measurable noncerebral lesion according to RECIST 1.1
  • * No prior systemic treatment for metastatic NSCLC
  • * Histologic or cytopathologic evidence of the presence of small cell lung carcinoma, or non-squamous NSCLC histology.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Summit Therapeutics,

Study Record Dates

2028-12-31