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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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) 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

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. pericardium, 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

Banner University Medical Center
Phoenix, Arizona 85006

TMC Healthcare
Tucson, Arizona 85711

University of Arkansas
Little Rock, Arkansas 72205

LA Cancer Network
Anaheim, California 92801

The Oncology Institute of Hope & Innovation
Cerritos, California 90703

University of Southern California (USC)
Los Angeles, California 90033

Cedar Sinai Medical Center
Los Angeles, California 90048

Valkyrie Clinical Trials
Los Angeles, California 90067

Sutter Institute for Medical Research
Sacramento, California 95816

UC Davis Medical Center
Sacramento, California 95817

University of California Los Angeles (UCLA)
Santa Monica, California 90404

Providence Medical Foundation
Santa Rosa, California 95403

Kaiser Permanente
Vallejo, California 94589

Rocky Mountain Cancer
Lone Tree, Colorado 80124

Banner MD Anderson Cancer Center at North Colorado Medical Center
Loveland, Colorado 80538

Hartford Hospital
Hartford, Connecticut 06053

Yale University
New Haven, Connecticut 06510

Florida Cancer Specialists & Research Institute (FCS)-East
Fort Myers, Florida 33901

BioResearch Partner- Hialeah Hospital
Hialeah, Florida 33013

Mayo Clinic
Jacksonville, Florida 32224

Cancer Specialists of North Florida
Jacksonville, Florida 32256

Ocala Oncology
Ocala, Florida 34474

Cancer Care of Brevard
Palm Bay, Florida 32901

Memorial Cancer Institute
Pembroke Pines, Florida 33028

Ascension Sacred Heart Health System
Pensacola, Florida 32504

Exigent Network
Petersburg, Florida 33709

BRCR Medical Center Inc
Plantation, Florida 33322

Florida Cancer Specialists & Research Institute (FCS) - North
St. Petersburg, Florida 33705

BRCR Medical Center Inc.
Tamarac, Florida 33321

Florida Cancer Specialists & Research Institute (FCS)-South
West Palm Beach, Florida 33401

Illinois Cancer Care
Peoria, Illinois 61615

University of Kansas Cancer Center
Westwood, Kansas 66205

Baptist Health
Lexington, Kentucky 40503

Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21187

Ascension Saint Agnes Hospital
Baltimore, Maryland 21229

Lahey Hospital
Burlington, Massachusetts 01805

University of Michigan
Ann Arbor, Michigan 48109

Trinity Health
Ann Arbor, Michigan 48197

Karmanos Cancer Insitute
Detroit, Michigan 48201

Henry Ford Hospital
Detroit, Michigan 48202

Mayo Clinic
Rochester, Minnesota 55905

Park Nicollet Institute
Saint Paul, Minnesota 55101

American Oncology Partners, PA
Kansas City, Missouri 64132

Washington University St.Louis
St Louis, Missouri 63110

St. Vincent Cancer Center
Billings, Montana 59102

University of Nebraska Medical Center (UNMC)
Omaha, Nebraska 68105

Mount Sinai
New York, New York 10029

Memorial Sloan Kettering
New York, New York 10065

University of North Carolina
Chapel Hill, North Carolina 27514

Levine Center
Charlotte, North Carolina 28204

Oncology Hematology Care (OHC), Inc
Cincinnati, Ohio 45242

University Hospitals Case Medical Center
Cleveland, Ohio 44106

Cleveland Clinic
Cleveland, Ohio 44195

Willamette Valley Cancer Institute and Research Center (WVCI)
Eugene, Oregon 97401

Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425

Prisma Health-Upstate
Greenville, South Carolina 29605

West Cancer Center
Memphis, Tennessee 38138

SCRI-Nashville
Nashville, Tennessee 37203

Texas Oncology- Austin
Austin, Texas 78745

Texas Oncology-Dallas
Dallas, Texas 75246

UT Southwestern Medical Center
Dallas, Texas 75390

Houston Methodist Hospital
Houston, Texas 77030

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

Texas Oncology-San Antonio
San Antonio, Texas 78216

Texas Oncology-Tyler
Tyler, Texas 75702

University of Texas at Tyler
Tyler, Texas 75708

Virginia Oncology Associates
Norfolk, Virginia 23502

Virginia Cancer
Reston, Virginia 20190

Swedish Cancer Institute
Seattle, Washington 98103

Cancer Care NW Centers
Spokane, Washington 99202

Carbone Cancer Center
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

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.