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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
2026-03-12
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 (195)
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Marin Cancer Care Inc
Greenbrae, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
BioResearch Partner
Hialeah, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Piedmont Cancer Institute, PC
Atlanta, 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
Profound Research, LLC
Farmington Hills, Michigan, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
San Juan Oncology Associates
Farmington, New Mexico, 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
Oregon Health and Science University
Portland, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Reading Hospital - McGlinn Cancer Institute
West Reading, Pennsylvania, United States
Baptist Cancer Center
Memphis, Tennessee, 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
Hospital Britanico
Ciudad Autonoma Buenos Aires, Argentina
Centro Oncologico Korben
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
Jewish General Hospital
Montreal, Quebec, Canada
Centre Hospitalier Regional De Rimouski
Rimouski, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
West China Hospital - Sichuan University
Chengdu, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, China
Shanghai East Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Aarhus Universitetshospital
Aarhus N, Denmark
Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed
Herlev, Denmark
Rigshospitalet
København Ø, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, Denmark
Onkologisk Ambulatorium - Sønderborg
Sønderborg, Denmark
CHU Angers
Angers, France
Hopital Avicenne
Bobigny, France
Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, France
Centre Francois Baclesse
Caen, France
Centre Leon Berard
Lyon, France
CHU Montpellier
Montpellier, France
Centre Antoine Lacassagne
Nice, France
Groupe Hospitalier Paris Saint Joseph
Paris, France
Hopital Tenon
Paris, France
CHU Bordeaux
Pessac, France
Centre Hospitalier Universitaire de Reims
Reims, France
CH de Saint Quentin
Saint-Quentin, France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, France
Centre Hospitalier Bretagne Atlantique Vannes
Vannes, France
Vivantes - Klinikum Im Friedrichshain;Innere Medizin ? Hämatologie, Onkologie und Palliativmedizin
Berlin, Germany
Charite - Universitätsmedizin Berlin
Berlin, Germany
Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus;Medizinische Klinik und Poliklinik I
Dresden, Germany
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
Asklepios Fachkliniken GmbH
Gauting, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
KRH Klinikum Siloah-Oststadt-Heidehaus
Hanover, Germany
Universität Des Saarlandes
Homburg, Germany
Lungenfachklinik Immenhausen
Immenhausen, Germany
Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, Germany
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
Löwenstein, Germany
Universität Mannheim
Mannheim, Germany
Pius Hospital Oldenburg
Oldenburg, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Klinikum Würzburg Mitte gGmbH
Würzburg, Germany
Sotiria General Hospital of Athens
Athens, Greece
Alexandras Hospital
Athens, Greece
Errikos Dynan Hospital
Athens, Greece
University Hospital of Larissa
Larissa, Greece
Interbalkan Medical Center of Thessaloniki
Thessaloniki, Greece
Theageneion Anticancer Hospital
Thessaloniki, Greece
Ag. Loukas Hospital
Thessaloniki, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital Department of Clinical Oncology
Kowloon, Hong Kong
Prince of Wales Hosp
Shatin, Hong Kong
Matrai Gyogyintezet
Mátraháza, Hungary
Református Pulmonológiai Centrum
Törökbálint, Hungary
St James Hospital
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland
Tallaght Hospital
Dublin, Ireland
Mater Misecordiae University Hospital
Dublin, Ireland
Ospedale Giuseppe Moscati
Statte, Apulia, Italy
AORN Ospedali dei Colli Ospedale Monaldi
Naples, Campania, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Campania, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, Italy
Presidio san salvatore muraglia
Pesaro, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
Policlinico Universitario "Agostino Gemelli"
Rome, Lazio, Italy
IEO Istituto Europeo di Oncologia
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, Italy
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily, Italy
USL 6 Toscana Nord Ovest ? P.O. Livorno
Livorno, Tuscany, Italy
Ospedale P. Pederzoli Casa di cura Privata
Peschiera Del Garda (VR), Veneto, Italy
Kyushu University Hospital
Fukuoka, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
ARKE Estudios Clínicos S.A. de C.V.
Mexico City, Mexico
Ziekenhuis Rijnstate
Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, Netherlands
Isala
Zwolle, Netherlands
Harbour Cancer and Wellness
Auckland, New Zealand
Centrum Pulmonologii i Torakochirurgii
Bystra, Poland
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland
Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
Krakow, Poland
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, Poland
Radomskie Centrum Onkologii
Radom, Poland
Instytut Gruzlicy I Chorob Pluc
Warsaw, Poland
Mazowiecki Szpital Onkologiczny
Wieliszew, Poland
Dolnoslaskie Centrum Chorob Pluc
Wroclaw, Poland
Hospital de Braga
Braga, Portugal
Hospital Beatriz Angelo
Loures, Portugal
IPO do Porto
Porto, Portugal
CHVNG/E_Unidade 1
Vila Nova de Gaia, Portugal
National University Hospital
Singapore, Singapore
National Cancer Centre
Singapore, Singapore
Wits Donald Gordon Clinical Trial Centre
Parktown, South Africa
Chris Hani Baragwanath Clinical Trial Site
Soweto, South Africa
Pusan National University Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Clinica Universidad de Navarra Madrid
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Universitaetsspital Basel
Basel, Switzerland
Kantonsspital Graubünden Medizin Onkologie
Chur, Switzerland
Hôpital Universitaire de Genève (HUG)
Geneva, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
E-DA Hospital
Kaohsiung City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
National Taiwan University Cancer Center
Zhongzheng Dist., Taiwan
Blackpool Teaching Hospitals NHS Foundation Trust , Victoria Hospital
Blackpool, United Kingdom
Bristol Haematology & Oncology Centre
Bristol, United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, United Kingdom
Velindre NHS Trust - Velindre Cancer Centre
Cardiff, United Kingdom
Barts and the London NHS Trust
London, United Kingdom
Royal Marsden Hospital - Fulham
London, United Kingdom
Sarah Cannon Research Institute
London, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom