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
Status: Recruiting
Location: See all (63) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
• Measurable disease, as defined by RECIST v1.1
• No prior systemic treatment for advanced or metastatic NSCLC
• Documentation of the presence of a KRAS G12C mutation
• Documentation of known PD-L1 expression status in tumor tissue
• Availability of a representative tumor specimen
• Adequate end-organ function
• Eligible to receive a platinum-based chemotherapy regimen
Locations
United States
Alaska
Alaska Oncology and Hematology
RECRUITING
Anchorage
California
Marin Cancer Care Inc
RECRUITING
Greenbrae
Florida
BioResearch Partner
RECRUITING
Hialeah
Georgia
Summit Cancer Care PC
RECRUITING
Savannah
Illinois
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Michigan
Profound Research, LLC
RECRUITING
Farmington Hills
Missouri
Missouri Baptist Medical Center
RECRUITING
St Louis
New Mexico
San Juan Oncology Associates
RECRUITING
Farmington
New York
Clinical Research Alliance
RECRUITING
Westbury
Tennessee
Baptist Cancer Center
RECRUITING
Memphis
Texas
Renovatio Clinical - El Paso
RECRUITING
El Paso
JPS Health Network
RECRUITING
Fort Worth
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Community Clinical Trials
RECRUITING
Kingwood
Renovatio Clinical
RECRUITING
The Woodlands
University of Texas Health Center at Tyler
RECRUITING
Tyler
Other Locations
Australia
Sunshine Coast University Hospital
RECRUITING
Birtinya
Monash Health
RECRUITING
Clayton
Brazil
Fundação Pio XII Hospital de Câncer de Barretos
RECRUITING
Barretos
Irmandade Da Santa Casa de Misericordia de Porto Alegre
RECRUITING
Porto Alegre
Instituto do Cancer do Estado de Sao Paulo - ICESP
RECRUITING
São Paulo
Canada
Royal Victoria Regional Health Centre
RECRUITING
Barrie
Centre Hospitalier Regional De Rimouski
RECRUITING
Rimouski
China
Shanghai East Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus N
France
CH de Saint Quentin
RECRUITING
Saint-quentin
Germany
Vivantes - Klinikum Im Friedrichshain;Innere Medizin ? Hämatologie, Onkologie und Palliativmedizin
RECRUITING
Berlin
Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus;Medizinische Klinik und Poliklinik I
RECRUITING
Dresden
Klinikum Esslingen
RECRUITING
Esslingen Am Neckar
Krankenhaus Martha-Maria Halle-Doelau gGmbH
RECRUITING
Halle
KRH Klinikum Siloah-Oststadt-Heidehaus
RECRUITING
Hanover
Universität Des Saarlandes
RECRUITING
Homburg
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Vincentius-Diakonissen-Kliniken gAG
RECRUITING
Karlsruhe
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Tuen Mun Hospital
RECRUITING
Hong Kong
Queen Elizabeth Hospital Department of Clinical Oncology
RECRUITING
Kowloon
Prince of Wales Hosp
RECRUITING
Shatin
Poland
Centrum Pulmonologii i Torakochirurgii
RECRUITING
Bystra
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
RECRUITING
Krakow
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
RECRUITING
Lublin
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
RECRUITING
Olsztyn
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
RECRUITING
Poznan
Instytut Gruzlicy I Chorob Pluc
RECRUITING
Warsaw
Mazowiecki Szpital Onkologiczny
RECRUITING
Wieliszew
Dolnoslaskie Centrum Chorob Pluc
RECRUITING
Wroclaw
Portugal
Hospital Beatriz Angelo
RECRUITING
Loures
IPO do Porto
RECRUITING
Porto
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Korea University Guro Hospital
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
Singapore
National Cancer Centre
RECRUITING
Singapore
Switzerland
Kantonsspital Graubünden Medizin Onkologie
RECRUITING
Chur
Hôpital Universitaire de Genève (HUG)
RECRUITING
Geneva
Taiwan
E-DA Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Chung Shan Medical University Hospital
RECRUITING
Taichung
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
East Kent Hospitals University NHS Foundation Trust
RECRUITING
Canterbury
Barts and the London NHS Trust
RECRUITING
London
Contact Information
Primary
Reference Study ID Number: CO45042 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2030-10-31
Participants
Target number of participants: 600
Treatments
Experimental: Divarasib + Pembrolizumab
Participants will receive divarasib orally, once daily (QD) and pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W)
Active_comparator: Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin
Participants will receive pembrolizumab, pemetrexed and carboplatin or cisplatin via IV infusion Q3W
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical