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ACTIVE NOT RECRUITING
NCT05899608
PHASE3

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

Sponsor: Summit Therapeutics

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2023-10-26

Completion Date

2029-12-31

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

Ivonescimab Injection

Subject will receive ivonescimab and chemotherapy as an IV injection

BIOLOGICAL

Pembrolizumab Injection

Subject will receive pembrolizumab and chemotherapy as an IV injection

Locations (260)

Banner University Medical Center

Phoenix, Arizona, United States

TMC Healthcare

Tucson, Arizona, United States

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, United States

University of Arkansas

Little Rock, Arkansas, United States

LA Cancer Network

Anaheim, California, United States

The Oncology Institute of Hope & Innovation

Cerritos, California, United States

University of Southern California (USC)

Los Angeles, California, United States

Cedar Sinai Medical Center

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Sutter Institute for Medical Research

Sacramento, California, United States

UC Davis Medical Center

Sacramento, California, United States

University of California Los Angeles (UCLA)

Santa Monica, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Kaiser Permanente

Vallejo, California, United States

Rocky Mountain Cancer

Lone Tree, Colorado, United States

Banner MD Anderson Cancer Center at North Colorado Medical Center

Loveland, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Florida Cancer Specialists & Research Institute (FCS)-East

Fort Myers, Florida, United States

BioResearch Partner- Hialeah Hospital

Hialeah, Florida, United States

Memorial Healthcare System

Hollywood, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Ocala Oncology

Ocala, Florida, United States

Cancer Care of Brevard

Palm Bay, Florida, United States

Ascension Sacred Heart Health System

Pensacola, Florida, United States

Exigent Network

Petersburg, Florida, United States

BRCR Medical Center Inc

Plantation, Florida, United States

Florida Cancer Specialists & Research Institute (FCS) - North

St. Petersburg, Florida, United States

BRCR Medical Center Inc.

Tamarac, Florida, United States

Florida Cancer Specialists & Research Institute (FCS)-South

West Palm Beach, Florida, United States

Central Georgia Cancer Care

Macon, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Illinois Cancer Care P.C.

Peoria, Illinois, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Baptist Health

Lexington, Kentucky, United States

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Ascension Saint Agnes Hospital

Baltimore, Maryland, United States

Lahey Hospital

Burlington, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Trinity Health

Ann Arbor, Michigan, United States

Karmanos Cancer Insitute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Park Nicollet Institute

Saint Paul, Minnesota, United States

American Oncology Partners, PA

Kansas City, Missouri, United States

Washington University St.Louis

St Louis, Missouri, United States

St. Vincent Cancer Center

Billings, Montana, United States

University of Nebraska Medical Center (UNMC)

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Mount Sinai

New York, New York, United States

Memorial Sloan Kettering

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Levine Center

Charlotte, North Carolina, United States

Oncology Hematology Care (OHC), Inc

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Willamette Valley Cancer Institute and Research Center (WVCI)

Eugene, Oregon, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Prisma Health-Upstate

Greenville, South Carolina, United States

West Cancer Center

Memphis, Tennessee, United States

SCRI-Nashville

Nashville, Tennessee, United States

Texas Oncology- Austin

Austin, Texas, United States

Texas Oncology-Dallas

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology-San Antonio

San Antonio, Texas, United States

Texas Oncology-Tyler

Tyler, Texas, United States

University of Texas at Tyler

Tyler, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Cancer

Reston, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Cancer Care NW Centers

Spokane, Washington, United States

Carbone Cancer Center

Madison, Wisconsin, United States

az Glorieux

Ronse, Belgium

CHU UC Louvain Namur

Yvoir, Belgium

London Regional (LRCP)

London, Ontario, Canada

Ottawa Cancer Center

Ottawa, Ontario, Canada

Saskatchewan Cancer

Regina, Saskatchewan, Canada

Fu Yang People's Hospital

Yangzhou, Anhui, China

Beijing Chest Hospital

Tongzhou, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Fujian Cancer Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Hainan General Hospital

Haikou, Hainan, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan University of Science and Technology Affiliated Anyang Cancer Hospital

Anyang, Henan, China

Nanyang Central Hospital

Nanyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Yangtze University

Jingzhou, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Hunan Cancer Hospital Thoracic Medicine 1

Changsha, Hunan, China

The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

And 160 more locations on ClinicalTrials.gov