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 • ClinicalTrials.gov ID: NCT06793215
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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).
Interventions
-
Divarasib
(Drug)
Divarasib will be administered orally QD
-
Pembrolizumab
(Drug)
Pembrolizumab will be administered via IV infusion Q3W
-
Pemetrexed
(Drug)
Pemetrexed will be administered via IV infusion Q3W
-
Carboplatin
(Drug)
Carboplatin will be administered via IV infusion Q3W
-
Cisplatin
(Drug)
Cisplatin will be administered via IV infusion Q3W
Eligibility criteria
Conditions
Locations
- 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
- CHU de Quebec - Hopital de l'Enfant-Jesus — Québec, Canada
- Anhui Provincial Hospital(The First Affiliated Hospital of USTC) — Hefei, Anhui, China
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
- Beijing Cancer Hospital — Beijing, China
- Hunan Cancer Hospital — Changsha, China
- West China Hospital - Sichuan University — Chengdu, China
- The First Affilicated Hospital, Sun Yat-sen University — Guangzhou, China
- Sir Run Run Shaw Hospital Zhejiang University — Hangzhou, China
- Harbin Medical University Cancer Hospital — Harbin, China
- Shandong Cancer Hospital — Jinan, China
- Yunnan Cancer Hospital — Kunming, China
- Nantong Tumor Hospital — Nantong, China
- Fudan University Shanghai Cancer Center — Shanghai, China
- Shanghai East Hospital — Shanghai, China
- Shanghai Pulmonary Hospital — Shanghai, China
- Tumor Hospital of the affiliated medical college of Shantou University — Shantou, China
- Hubei Cancer Hospital — Wuhan, China
- Sjællands Universitetshospital, Køge;Onkologisk Afdeling — Køge, Denmark > Enter Text, Denmark
- Aarhus Universitetshospital — Aarhus N, Denmark
- Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed — Herlev, Denmark
- Rigshospitalet — København Ø, 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
- Helios Klinikum Emil von Behring GmbH — 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
- LungenClinic Grosshansdorf GmbH — Großhansdorf, Germany
- Christliches Klinikum Halle (Saale) GmbH, Standort Dölau — Halle, Germany
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
- Asklepios Klinik Harburg — Hamburg, Germany
- KRH Klinikum Siloah-Oststadt-Heidehaus — Hanover, Germany
- Thoraxklinik Heidelberg gGmbH — Heidelberg, Germany
- Universität Des Saarlandes — Homburg, Germany
- Lungenfachklinik Immenhausen — Immenhausen, Germany
- ViDia Christliche Kliniken Karlsruhe;Medizinische Klinik 2, Studienzentrale Prof. MzB. / Raum G.018 — Karlsruhe, Germany
- SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein — Löwenstein, Germany
- Universitätsklinikum Schleswig-Holstein — Lübeck, Germany
- Universität Mannheim — Mannheim, Germany
- Klinikum Bogenhausen — München, Germany
- Universitaetsklinikum Muenster — Münster, Germany
- Pius Hospital Oldenburg — Oldenburg, Germany
- Universitätsklinikum Regensburg — Regensburg, Germany
- Universitätsklinikum Tübingen — Tübingen, 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
- Orszagos Koranyi Pulmonologiai Intezet — Budapest, Hungary
- Matrai Gyogyintezet — Mátraháza, Hungary
- Pécsi Tudományegyetem — Pécs, 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
- Azienda Ospedaliera San Gerardo di Monza — Monza MI, 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
- Fujita Health University Hospital — Aichi, Japan
- Kyushu University Hospital — Fukuoka, Japan
- Kurume University Hospital — Fukuoka, Japan
- Hakodate Goryoukaku Hospital — Hokkaido, Japan
- Hyogo Medical University Hospital — Hyōgo, Japan
- Kagoshima University Hospital — Kagoshima, Japan
- Kanagawa Cancer Center — Kanagawa, Japan
- Sendai Kousei Hospital — Miyagi, Japan
- Niigata University Medical & Dental Hospital — Niigata, Japan
- Okayama University Hospital — Okayama, Japan
- Osaka Metropolitan University Hospital — Osaka, Japan
- Kansai Medical University Hospital — Osaka, Japan
- Kindai University Hospital — Osaka, Japan
- Tohoku University Hospital — Sendai, Japan
- Shizuoka Cancer Center — Shizuoka, Japan
- National Cancer Center Hospital — Tokyo, Japan
- Juntendo University Hospital — Tokyo, Japan
- The Cancer Institute Hospital of JFCR — Tokyo, Japan
- Tokyo Medical University Hospital — Tokyo, Japan
- Wakayama Medical University Hospital — Wakayama, Japan
- Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico
- ARKE Estudios Clínicos S.A. de C.V. — Mexico City, Mexico
- Meander Medisch Centrum — Amersfoort, Utrecht, Netherlands
- NKI The Netherlands Cancer Institute — Amsterdam, Netherlands
- Ziekenhuis Rijnstate — Arnhem, Netherlands
- Amphia Ziekenhuis — Breda, Netherlands
- Ziekenhuis St. Jansdal — Harderwijk, Netherlands
- Medisch Centrum Haaglanden, locatie Antoniushove — Leidschendam, Netherlands
- Isala — Zwolle, Netherlands
- Harbour Cancer and Wellness — Auckland, New Zealand
- Wellington Hospital — Newtown, 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
- University of Pretoria Oncology Department — Pretoria, 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
- Complejo Hospitalario Universitario Insular?Materno Infantil — Las Palmas de Gran Canaria, LAS Palmas, Spain
- Clinica Universitaria de Navarra — Pamplona, Navarre, Spain
- Hospital Universitari Vall d Hebron — Barcelona, Spain
- Hospital Clinic i Provincial de Barcelona — Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
- ICO L'Hospitalet — 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
- Kantonsspital Baden — Baden, Switzerland
- 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
- Hull University Teaching Hospitals NHS Trust — Hull, 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
- Oxford University Hospitals NHS Trust - Churchill Hospital — Oxford, United Kingdom
- Royal Marsden NHS Foundation Trust — Sutton, United Kingdom
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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