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RECRUITING
NCT06793215
PHASE3

A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Official title: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-10-24

Completion Date

2030-10-31

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DRUG

Divarasib

Divarasib will be administered orally QD

DRUG

Pembrolizumab

Pembrolizumab will be administered via IV infusion Q3W

DRUG

Pemetrexed

Pemetrexed will be administered via IV infusion Q3W

DRUG

Carboplatin

Carboplatin will be administered via IV infusion Q3W

DRUG

Cisplatin

Cisplatin will be administered via IV infusion Q3W

Locations (288)

Alaska Oncology and Hematology

Anchorage, Alaska, United States

City of Hope - Phoenix

Goodyear, Arizona, United States

Community Cancer Institute (CCI)

Clovis, California, United States

Marin Cancer Care Inc

Greenbrae, California, United States

UCI Health-CIACC

Irvine, California, United States

UCLA Oncology Center

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

University of California Irvine

Orange, California, United States

Palo Alto Medical Foundation Research Center

Palo Alto, California, United States

Sutter Institute for Medical Research

Roseville, California, United States

California Pacific Medical Center

San Francisco, California, United States

UC Health Oncology Research

Colorado Springs, Colorado, United States

Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System

Fort Collins, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Florida Cancer Specialists - SOUTH - SCRI - PPDS

Fort Myers, Florida, United States

University of Florida Health at Shands

Gainesville, Florida, United States

BioResearch Partner

Hialeah, Florida, United States

Memorial Healthcare System - Memorial Regional Hospital

Hollywood, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Advent Health Orlando

Orlando, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

Florida Cancer Specialists - NORTH - SCRI - PPDS

St. Petersburg, Florida, United States

Florida Cancer Specialists - EAST - SCRI - PPDS

West Palm Beach, Florida, United States

Piedmont Cancer Institute, PC

Atlanta, Georgia, United States

City of Hope® Atlanta

Newnan, Georgia, United States

Summit Cancer Care PC

Savannah, Georgia, United States

St. Luke's Cancer Institute

Boise, Idaho, United States

Affiliated Oncologists, LLC

Chicago Ridge, Illinois, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

City of Hope® Cancer Center Chicago

Zion, Illinois, United States

Mission Cancer + Blood - IMMC

Des Moines, Iowa, United States

University of Iowa

Iowa City, Iowa, United States

Saint Agnes Hospital - Baltimore - Hunt - PPDS

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Profound Research, LLC

Farmington Hills, Michigan, United States

Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

NHO Revive Research Institute

Lincoln, Nebraska, United States

Cancer Care Specialists

Reno, Nevada, United States

AsteraCancer Care

East Brunswick, New Jersey, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Montefiore Einstein Cancer Center

The Bronx, New York, United States

Clinical Research Alliance

Westbury, New York, United States

Firsthealth of The Carolinas

Pinehurst, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States

Reading Hospital - McGlinn Cancer Institute

West Reading, Pennsylvania, United States

Baptist Cancer Center

Memphis, Tennessee, United States

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Renovatio Clinical - El Paso

El Paso, Texas, United States

JPS Health Network

Fort Worth, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Community Clinical Trials

Kingwood, Texas, United States

Texas Tech Health Science Center

Lubbock, Texas, United States

Renovatio Clinical

The Woodlands, Texas, United States

University of Texas Health Center at Tyler

Tyler, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Ascension Network - St Elizabeth's Hospital

Appleton, Wisconsin, United States

Ascension Columbia St. Mary's

Milwaukee, Wisconsin, United States

Hospital Aleman de Buenos Aires

Buenos Aires, Argentina

Hospital Italiano

Buenos Aires, Argentina

Hospital Britanico

Ciudad Autonoma Buenos Aires, Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, Argentina

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Monash Health

Clayton, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

AZORG Campus Aalst-Moorselbaan

Aalst, Belgium

UZ Brussel

Brussels, Belgium

Cliniques Universitaires St-Luc

Brussels, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

CHU de Liège (Sart Tilman)

Liège, Belgium

CHU HELORA - Hôpital de Mons - Site Kennedy

Mons, Belgium

AZ Delta (Campus Rumbeke)

Roeselare, Belgium

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

Liga Norte Riograndense Contra O Câncer

Natal, Rio Grande do Norte, Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

Kelowna, British Columbia, Canada

BC Cancer - Victoria

Victoria, British Columbia, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

William Osler Health Centre - Brampton Civic Hospital

Brampton, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Regional De Rimouski

Rimouski, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

And 188 more locations on ClinicalTrials.gov