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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

TMC Healthcare
Tucson 5318313, Arizona 5551752 85711

University of Arkansas
Little Rock 4119403, Arkansas 4099753 72205

LA Cancer Network
Anaheim 5323810, California 5332921 92801

The Oncology Institute of Hope & Innovation
Cerritos 5335663, California 5332921 90703

University of Southern California (USC)
Los Angeles 5368361, California 5332921 90033

Cedar Sinai Medical Center
Los Angeles 5368361, California 5332921 90048

Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067

Sutter Institute for Medical Research
Sacramento 5389489, California 5332921 95816

UC Davis Medical Center
Sacramento 5389489, California 5332921 95817

University of California Los Angeles (UCLA)
Santa Monica 5393212, California 5332921 90404

Providence Medical Foundation
Santa Rosa 5393287, California 5332921 95403

Kaiser Permanente
Vallejo 5405380, California 5332921 94589

Rocky Mountain Cancer
Lone Tree 5429208, Colorado 5417618 80124

Hartford Hospital
Hartford 4835797, Connecticut 4831725 06053

Yale University
New Haven 4839366, Connecticut 4831725 06510

Florida Cancer Specialists & Research Institute (FCS)-East
Fort Myers 4155995, Florida 4155751 33901

BioResearch Partner- Hialeah Hospital
Hialeah 4158476, Florida 4155751 33013

Cancer Specialists of North Florida
Jacksonville 4160021, Florida 4155751 32256

Ocala Oncology
Ocala 4166673, Florida 4155751 34474

Cancer Care of Brevard
Palm Bay 4167499, Florida 4155751 32901

Memorial Cancer Institute
Pembroke Pines 4168139, Florida 4155751 33028

Ascension Sacred Heart Health System
Pensacola 4168228, Florida 4155751 32504

Exigent Network
Petersburg, Florida 4155751 33709

BRCR
Plantation 4168782, Florida 4155751 33322

Florida Cancer Specialists & Research Institute (FCS) - North
St. Petersburg 4171563, Florida 4155751 33705

Florida Cancer Specialists & Research Institute (FCS)-South
West Palm Beach 4177887, Florida 4155751 33401

Illinois Cancer Care
Peoria 4905687, Illinois 4896861 61615

University of Kansas Cancer Center
Westwood 4281639, Kansas 4273857 66205

Baptist Health
Lexington 4297983, Kentucky 6254925 40503

Sidney Kimmel Comprehensive Cancer Center
Baltimore 4347778, Maryland 4361885 21187

Lahey Hospital
Burlington 4931737, Massachusetts 6254926 01805

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109

Trinity Health
Ann Arbor 4984247, Michigan 5001836 48197

Karmanos Cancer Insitute
Detroit 4990729, Michigan 5001836 48201

Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202

Park Nicollet Institute
Saint Paul 5045360, Minnesota 5037779 55101

American Oncology Partners, PA
Kansas City 4393217, Missouri 4398678 64132

Washington University St.Louis
St Louis 4407066, Missouri 4398678 63110

St. Vincent Cancer Center
Billings 5640350, Montana 5667009 59102

University of Nebraska Medical Center (UNMC)
Omaha 5074472, Nebraska 5073708 68105

Mount Sinai
New York 5128581, New York 5128638 10029

Memorial Sloan Kettering
New York 5128581, New York 5128638 10065

University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27514

Levine Center
Charlotte 4460243, North Carolina 4482348 28204

Oncology Hematology Care (OHC), Inc
Cincinnati 4508722, Ohio 5165418 45242

University Hospitals Case Medical Center
Cleveland 5150529, Ohio 5165418 44106

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195

Willamette Valley Cancer Institute and Research Center (WVCI)
Eugene 5725846, Oregon 5744337 97401

Medical University of South Carolina (MUSC)
Charleston 4574324, South Carolina 4597040 29425

Prisma Health-Upstate
Greenville 4580543, South Carolina 4597040 29605

West Cancer Center
Memphis 4641239, Tennessee 4662168 38138

SCRI-Nashville
Nashville 4644585, Tennessee 4662168 37203

Texas Oncology- Austin
Austin 4671654, Texas 4736286 78745

Texas Oncology-Dallas
Dallas 4684888, Texas 4736286 75246

UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Jianjun Zhang, MD
713-563-6096
jzhang20@mdanderson.org

Texas Oncology-San Antonio
San Antonio 4726206, Texas 4736286 78216

Texas Oncology-Tyler
Tyler 4738214, Texas 4736286 75702

University of Texas at Tyler
Tyler 4738214, Texas 4736286 75708

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502

Virginia Cancer
Reston 4781530, Virginia 6254928 20190

Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98103

Cancer Care NW Centers
Spokane 5811696, Washington 5815135 99202

Carbone Cancer Center
Madison 5261457, Wisconsin 5279468 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.