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

Purpose

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.

Condition

  • Non-Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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 - 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

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A - Ivonescimab and chemotherapy 		Subject will receive ivonescimab and chemotherapy
  • Biological: Ivonescimab Injection
    Subject will receive ivonescimab and chemotherapy as an IV injection
Active Comparator
Arm B - Pembrolizumab and chemotherapy 		Subject will receive pembrolizumab and chemotherapy
  • Biological: Pembrolizumab Injection
    Subject will receive pembrolizumab and chemotherapy as an IV injection

Recruiting Locations

Clinical Study Site
Tucson, Arizona 85711

Clinical Study Site
Little Rock, Arkansas 72205

Clinical Study Site
Los Angeles, California 90033

Clinical Study Site
Los Angeles, California 90067

Clinical Study Site
Sacramento, California 95817

Clinical Study Site
Santa Monica, California 90404

Clinical Study Site
Santa Rosa, California 95403

Clinical Study Site
Lone Tree, Colorado 80124

Clinical Study Site
Fort Myers, Florida 33901

Clinical Study Site
Jacksonville, Florida 32256

Clinical Study Site
Ocala, Florida 34474

Clinical Study Site
Palm Bay, Florida 32901

Clinical Study Site
Pembroke Pines, Florida 33028

Clinical Study Site
Pensacola, Florida 32503

Clinical Study Site
Petersburg, Florida 33709

Clinical Study Site
Plantation, Florida 33322

Clinical Study Site
Saint Petersburg, Florida 33705

Clinical Study Site
West Palm Beach, Florida 33401

Clinical Study Site
Lexington, Kentucky 40503

Clinical Study Site
Burlington, Massachusetts 01805

Clinical Study Site
Ann Arbor, Michigan 48109

Clinical Study Site
Detroit, Michigan 48202

Clinical Study Site
Saint Paul, Minnesota 55101

Clinical Study Site
Billings, Montana 59102

Clinical Study Site
New York, New York 10029

Clinical Study Site
New York, New York 10065

Clinical Study Site
Chapel Hill, North Carolina 27514

Clinical Study Site
Charlotte, North Carolina 28204

Clinical Study Site
Cincinnati, Ohio 45242

Clinical Study Site
Cleveland, Ohio 44106

Clinical Study Site
Cleveland, Ohio 44195

Clinical Study Site
Eugene, Oregon 97401

Clinical Study Site
Greenville, South Carolina 29605

Clinical Study Site
Nashville, Tennessee 37203

Clinical Study Site
Austin, Texas 78745

Clinical Study Site
Dallas, Texas 75246

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Jianjun Zhang, MD
713-563-6096
jzhang20@mdanderson.org

Clinical Study Site
Tyler, Texas 75702

Clinical Study Site
Norfolk, Virginia 23502

Clinical Study Site
Reston, Virginia 20190

Clinical Study Site
Seattle, Washington 98103

Clinical Study Site
Spokane, Washington 99202

Clinical Study Site
Madison, Wisconsin 53792

More Details

NCT ID
NCT05899608
Status
Recruiting
Sponsor
Summit Therapeutics

Study Contact

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