Recruiting

Phase 3

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

Sponsor:

Summit Therapeutics

Code:

NCT05899608

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ivonescimab Injection

Pembrolizumab Injection

Study Details

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT05899608

Start date

Oct 26, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A - Ivonescimab and chemotherapy

Subject will receive ivonescimab and chemotherapy

active comparator: Arm B - Pembrolizumab and chemotherapy

Subject will receive pembrolizumab and chemotherapy

Interventions

Ivonescimab Injection

Subject will receive ivonescimab and chemotherapy as an IV injection

Pembrolizumab Injection

Subject will receive pembrolizumab and chemotherapy as an IV injection

Primary outcome measure

Overall Survival (OS) [ Time Frame: approximately 4 years ]
Progression Free Survival (PFS) [ Time Frame: approximately 3 years ]

Central Contacts and Locations

Central contacts

Summit Clinical Trial Information

1-833-256-0522 medicalinformation@smmttx.com

Locations

Banner University Medical Center

Recruiting

Phoenix, Arizona, United States, 85006

TMC Healthcare

Recruiting

Tucson, Arizona, United States, 85711

Genesis Cancer and Blood Institute

Recruiting

Hot Springs, Arkansas, United States, 71913

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

LA Cancer Network

Recruiting

Anaheim, California, United States, 92801

The Oncology Institute of Hope & Innovation

Recruiting

Cerritos, California, United States, 90703

University of Southern California (USC)

Recruiting

Los Angeles, California, United States, 90033

Cedar Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Sutter Institute for Medical Research

Recruiting

Sacramento, California, United States, 95816

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

University of California Los Angeles (UCLA)

Recruiting

Santa Monica, California, United States, 90404

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Kaiser Permanente

Recruiting

Vallejo, California, United States, 94589

Rocky Mountain Cancer

Recruiting

Lone Tree, Colorado, United States, 80124

Banner MD Anderson Cancer Center at North Colorado Medical Center

Recruiting

Loveland, Colorado, United States, 80538

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06053

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Florida Cancer Specialists & Research Institute (FCS)-East

Recruiting

Fort Myers, Florida, United States, 33901

BioResearch Partner- Hialeah Hospital

Recruiting

Hialeah, Florida, United States, 33013

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Cancer Specialists of North Florida

Recruiting

Jacksonville, Florida, United States, 32256

Ocala Oncology

Recruiting

Ocala, Florida, United States, 34474

Cancer Care of Brevard

Recruiting

Palm Bay, Florida, United States, 32901

Memorial Cancer Institute

Recruiting

Pembroke Pines, Florida, United States, 33028

Ascension Sacred Heart Health System

Recruiting

Pensacola, Florida, United States, 32504

BRCR Medical Center Inc

Recruiting

Plantation, Florida, United States, 33322

Florida Cancer Specialists & Research Institute (FCS) - North

Recruiting

St. Petersburg, Florida, United States, 33705

Exigent Network

Recruiting

St. Petersburg, Florida, United States, 33709

BRCR Medical Center Inc.

Recruiting

Tamarac, Florida, United States, 33321

Florida Cancer Specialists & Research Institute (FCS)-South

Recruiting

West Palm Beach, Florida, United States, 33401

Central Georgia Cancer Care

Recruiting

Macon, Georgia, United States, 31210

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Illinois Cancer Care

Recruiting

Peoria, Illinois, United States, 61615

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Baptist Health

Recruiting

Lexington, Kentucky, United States, 40503

Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21187

Ascension Saint Agnes Hospital

Recruiting

Baltimore, Maryland, United States, 21229

Lahey Hospital

Recruiting

Burlington, Massachusetts, United States, 01805

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Trinity Health

Recruiting

Ann Arbor, Michigan, United States, 48197

Karmanos Cancer Insitute

Recruiting

Detroit, Michigan, United States, 48201

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Park Nicollet Institute

Recruiting

Saint Paul, Minnesota, United States, 55101

American Oncology Partners, PA

Recruiting

Kansas City, Missouri, United States, 64132

Washington University St.Louis

Recruiting

St Louis, Missouri, United States, 63110

St. Vincent Cancer Center

Recruiting

Billings, Montana, United States, 59102

University of Nebraska Medical Center (UNMC)

Recruiting

Omaha, Nebraska, United States, 68105

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Mount Sinai

Recruiting

New York, New York, United States, 10029

Memorial Sloan Kettering

Recruiting

New York, New York, United States, 10065

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27514

Levine Center

Recruiting

Charlotte, North Carolina, United States, 28204

Oncology Hematology Care (OHC), Inc

Recruiting

Cincinnati, Ohio, United States, 45242

University Hospitals Case Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Willamette Valley Cancer Institute and Research Center (WVCI)

Recruiting

Eugene, Oregon, United States, 97401

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Prisma Health-Upstate

Recruiting

Greenville, South Carolina, United States, 29605

West Cancer Center

Recruiting

Memphis, Tennessee, United States, 38138

SCRI-Nashville

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology- Austin

Recruiting

Austin, Texas, United States, 78745

Texas Oncology-Dallas

Recruiting

Dallas, Texas, United States, 75246

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jianjun Zhang, MD

713-563-6096 jzhang20@mdanderson.org

Texas Oncology-San Antonio

Recruiting

San Antonio, Texas, United States, 78216

Texas Oncology-Tyler

Recruiting

Tyler, Texas, United States, 75702

University of Texas at Tyler

Recruiting

Tyler, Texas, United States, 75708

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Virginia Cancer

Recruiting

Reston, Virginia, United States, 20190

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98103

Cancer Care NW Centers

Recruiting

Spokane, Washington, United States, 99202

Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

London Regional (LRCP)

Recruiting

London, Ontario, Canada, N6A5W9

Ottawa Cancer Center

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Saskatchewan Cancer

Recruiting

Regina, Saskatchewan, Canada, S4T7T1

More Information

Sponsor

Summit Therapeutics

Last update posted

Apr 30, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Summit Therapeutics on 2026-04-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.