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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
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
Divarasib
Divarasib will be administered orally QD
Pembrolizumab
Pembrolizumab will be administered via IV infusion Q3W
Pemetrexed
Pemetrexed will be administered via IV infusion Q3W
Carboplatin
Carboplatin will be administered via IV infusion Q3W
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