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 (151) 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
Piedmont Cancer Institute, PC
RECRUITING
Atlanta
Summit Cancer Care PC
RECRUITING
Savannah
Idaho
St. Luke's Cancer Institute
RECRUITING
Boise
Illinois
Hope and Healing Cancer Services
WITHDRAWN
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
Montefiore Einstein Cancer Center
RECRUITING
The Bronx
Clinical Research Alliance
RECRUITING
Westbury
Pennsylvania
St. Luke's University Health Network
RECRUITING
Bethlehem
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
Texas Tech Health Science Center
RECRUITING
Lubbock
Renovatio Clinical
RECRUITING
The Woodlands
University of Texas Health Center at Tyler
RECRUITING
Tyler
Other Locations
Argentina
Centro Oncologico Korben
RECRUITING
Ciudad Autonoma Buenos Aires
Hospital Britanico
RECRUITING
Ciudad Autonoma Buenos Aires
Australia
Sunshine Coast University Hospital
RECRUITING
Birtinya
Monash Health
RECRUITING
Clayton
Kinghorn Cancer Centre
RECRUITING
Darlinghurst
Austin Health
RECRUITING
Heidelberg
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
Calvary Mater Newcastle
RECRUITING
Warath
Belgium
AZORG Campus Aalst-Moorselbaan
RECRUITING
Aalst
Jessa Zkh (Campus Virga Jesse)
RECRUITING
Hasselt
CHU HELORA - Hôpital de Mons - Site Kennedy
RECRUITING
Mons
AZ Delta (Campus Rumbeke)
RECRUITING
Roeselare
Brazil
Fundação Pio XII Hospital de Câncer de Barretos
RECRUITING
Barretos
Centro Integrado de Oncologia de Curitiba
RECRUITING
Curitiba
Crio - Centro Regional Integrado de Oncologia
RECRUITING
Fortaleza
Liga Norte Riograndense Contra O Câncer
RECRUITING
Natal
Hospital Nossa Senhora da Conceicao
RECRUITING
Porto Alegre
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
BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
RECRUITING
Kelowna
Jewish General Hospital
RECRUITING
Montreal
Centre Hospitalier Regional De Rimouski
RECRUITING
Rimouski
China
West China Hospital - Sichuan University
RECRUITING
Chengdu
Sir Run Run Shaw Hospital Zhejiang University
RECRUITING
Hangzhou
Shanghai East Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus N
Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed
RECRUITING
Herlev
Rigshospitalet
RECRUITING
København Ø
Sjællands Universitetshospital, Roskilde
RECRUITING
Roskilde
France
CHU Angers
RECRUITING
Angers
Hopital Avicenne
RECRUITING
Bobigny
Hôpital Louis Pradel, Hospices Civils de Lyon
RECRUITING
Bron
Centre Francois Baclesse
RECRUITING
Caen
Centre Leon Berard
RECRUITING
Lyon
CHU Montpellier
RECRUITING
Montpellier
Groupe Hospitalier Paris Saint Joseph
RECRUITING
Paris
Hopital Tenon
RECRUITING
Paris
CHU Bordeaux
RECRUITING
Pessac
Centre Hospitalier Universitaire de Reims
RECRUITING
Reims
CH de Saint Quentin
RECRUITING
Saint-quentin
Centre Hospitalier Bretagne Atlantique Vannes
RECRUITING
Vannes
Germany
Charite - Universitätsmedizin Berlin
RECRUITING
Berlin
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
KEM/Evang. Kliniken Essen Mitte gGmbH
RECRUITING
Essen
Universitätsklinikum Essen
RECRUITING
Essen
Klinikum Esslingen
RECRUITING
Esslingen Am Neckar
Asklepios Fachkliniken GmbH
RECRUITING
Gauting
Krankenhaus Martha-Maria Halle-Doelau gGmbH
RECRUITING
Halle
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
KRH Klinikum Siloah-Oststadt-Heidehaus
RECRUITING
Hanover
Universität Des Saarlandes
RECRUITING
Homburg
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Vincentius-Diakonissen-Kliniken gAG
RECRUITING
Karlsruhe
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
RECRUITING
Löwenstein
Universität Mannheim
RECRUITING
Mannheim
Pius Hospital Oldenburg
RECRUITING
Oldenburg
Universitätsklinikum Regensburg
RECRUITING
Regensburg
Greece
Alexandras Hospital
RECRUITING
Athens
Errikos Dynan Hospital
RECRUITING
Athens
Ag. Loukas Hospital
RECRUITING
Thessaloniki
Interbalkan Medical Center of Thessaloniki
RECRUITING
Thessaloniki
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
Hungary
Matrai Gyogyintezet
RECRUITING
Mátraháza
Reformatus Pulmonologiai Centrum
RECRUITING
Törökbálint
Italy
USL 6 Toscana Nord Ovest ? P.O. Livorno
RECRUITING
Livorno
IEO Istituto Europeo di Oncologia
RECRUITING
Milan
Istituto Nazionale Tumori Fondazione G. Pascale
RECRUITING
Napoli
Presidio san salvatore muraglia
RECRUITING
Pesaro
Ospedale P. Pederzoli Casa di cura Privata
RECRUITING
Peschiera Del Garda (vr)
Ospedale Giuseppe Moscati
RECRUITING
Statte
Japan
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Netherlands
Amphia Ziekenhuis
RECRUITING
Breda
Ziekenhuis St. Jansdal
RECRUITING
Harderwijk
Isala
RECRUITING
Zwolle
New Zealand
Harbour Cancer and Wellness
RECRUITING
Auckland
Poland
Centrum Pulmonologii i Torakochirurgii
RECRUITING
Bystra
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gda?sk
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
Radomskie Centrum Onkologii
RECRUITING
Radom
Instytut Gruzlicy I Chorob Pluc
RECRUITING
Warsaw
Mazowiecki Szpital Onkologiczny
RECRUITING
Wieliszew
Dolnoslaskie Centrum Chorob Pluc
RECRUITING
Wroclaw
Portugal
Hospital de Braga
RECRUITING
Braga
Hospital Beatriz Angelo
RECRUITING
Loures
IPO do Porto
RECRUITING
Porto
CHVNG/E_Unidade 1
RECRUITING
Vila Nova De Gaia
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Korea University Guro Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
Singapore
National Cancer Centre
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
RECRUITING
Barcelona
Clinica Universidad de Navarra Madrid
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Clinico Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Son Espases
RECRUITING
Palma De Mallorca
Clinica Universitaria de Navarra
RECRUITING
Pamplona
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Switzerland
Universitaetsspital Basel
RECRUITING
Basel
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
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
National Taiwan University Cancer Center
RECRUITING
Zhongzheng Dist.
United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust , Victoria Hospital
RECRUITING
Blackpool
Bristol Haematology & Oncology Centre
RECRUITING
Bristol
East Kent Hospitals University NHS Foundation Trust
RECRUITING
Canterbury
Velindre NHS Trust - Velindre Cancer Centre
RECRUITING
Cardiff
Barts and the London NHS Trust
RECRUITING
London
Royal Marsden Hospital - Fulham
RECRUITING
London
Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
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