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 (Krascendo 2)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer; KRAS G12C Lung Cancer
• Intervention / Treatment: Drug: Divarasib; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: CO45042 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • Recruiting
    • Hospital Italiano
  • Buenos Aires, Argentina, C1118AAT
    • Recruiting
    • Hospital Aleman de Buenos Aires
  • Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
    • Recruiting
    • Clinica Adventista Belgrano
  • Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
    • Recruiting
    • Centro Oncologico Korben
  • Ciudad Autonoma Buenos Aires, Argentina, C1280AEB
    • Recruiting
    • Hospital Britanico
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • Kinghorn Cancer Centre
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • Liverpool Hospital
    • Waratah, New South Wales, Australia, 2298
      • Recruiting
      • Calvary Mater Newcastle
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Recruiting
      • Sunshine Coast University Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Recruiting
      • Royal Hobart Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter Maccallum Cancer Centre
• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • AZORG Campus Aalst-Moorselbaan
  • Brussels, Belgium, 1090
    • Recruiting
    • Uz Brussel
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires St-Luc
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Zkh (Campus Virga Jesse)
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven Gasthuisberg
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liège (Sart Tilman)
  • Mons, Belgium, 7000
    • Recruiting
    • CHU HELORA - Hôpital de Mons - Site Kennedy
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta (Campus Rumbeke)
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60336-232
      • Recruiting
      • Crio - Centro Regional Integrado de Oncologia
  • Paraná
    • Curitiba, Paraná, Brazil, 80810-050
      • Recruiting
      • Centro Integrado de Oncologia de Curitiba
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59040150
      • Recruiting
      • Liga Norte Riograndense Contra o Cancer
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
      • Recruiting
      • Irmandade Da Santa Casa de Misericórdia de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90040-373
      • Recruiting
      • Hospital Nossa Senhora da Conceição
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Recruiting
      • Fundacao Pio Xii Hospital de Cancer de Barretos
    • São Paulo, São Paulo, Brazil, 01246-000
      • Recruiting
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Canada
  • Québec, Canada, G1J 1Z4
    • Recruiting
    • CHU de Quebec - Hopital de l'Enfant-Jesus
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • Recruiting
      • BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
    • Victoria, British Columbia, Canada, V8R 6V5
      • Recruiting
      • BC Cancer - Victoria
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Recruiting
      • Royal Victoria Regional Health Centre
    • Brampton, Ontario, Canada, L6R 3J7
      • Recruiting
      • William Osler Health Centre - Brampton Civic Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
    • Rimouski, Quebec, Canada, G5L 5T1
      • Recruiting
      • Centre Hospitalier Regional De Rimouski
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Recruiting
      • Saskatoon Cancer Centre
• China
  • Changsha, China, 410013
    • Recruiting
    • Hunan Cancer Hospital
  • Chengdu, China, 611130
    • Recruiting
    • West China Hospital - Sichuan University
  • Hangzhou, China, 310016
    • Recruiting
    • Sir Run Run Shaw Hospital Zhejiang University
  • Harbin, China, 150081
    • Recruiting
    • Harbin Medical University Cancer Hospital
  • Shanghai, China, 200433
    • Recruiting
    • Shanghai Pulmonary Hospital
  • Shanghai, China, 200120
    • Recruiting
    • Shanghai East Hospital
• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus Universitetshospital
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed
  • København Ø, Denmark, 2100
    • Recruiting
    • Rigshospitalet
  • Roskilde, Denmark, 4000
    • Recruiting
    • Sjællands Universitetshospital, Roskilde
  • Sønderborg, Denmark, 6400
    • Recruiting
    • Onkologisk Ambulatorium - Sønderborg
• France
  • Angers, France, 49933
    • Recruiting
    • Chu Angers
  • Bobigny, France, 93009
    • Recruiting
    • Hôpital Avicenne
  • Bron, France, 69677
    • Recruiting
    • Hôpital Louis Pradel, Hospices Civils de Lyon
  • Caen, France, 14076
    • Recruiting
    • Centre Francois Baclesse
  • Lyon, France, 69008
    • Recruiting
    • Centre Leon Berard
  • Montpellier, France, 34295
    • Recruiting
    • CHU Montpellier
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
  • Paris, France, 75014
    • Recruiting
    • Groupe hospitalier Paris saint Joseph
  • Paris, France, 75970
    • Recruiting
    • Hôpital Tenon
  • Pessac, France, 33604
    • Recruiting
    • CHU Bordeaux
  • Reims, France, 51092
    • Recruiting
    • Centre Hospitalier Universitaire de Reims
  • Saint-Quentin, France, 02321
    • Recruiting
    • CH de Saint Quentin
  • Strasbourg, France, 67091
    • Recruiting
    • CHU Strasbourg - Nouvel Hôpital Civil
  • Vannes, France, 56017
    • Recruiting
    • Centre Hospitalier Bretagne Atlantique Vannes
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charite - Universitatsmedizin Berlin
  • Berlin, Germany, 10249
    • Recruiting
    • Vivantes - Klinikum Im Friedrichshain;Innere Medizin ? Hämatologie, Onkologie und Palliativmedizin
  • Dresden, Germany, 01307
    • Recruiting
    • Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus;Medizinische Klinik und Poliklinik I
  • Essen, Germany, 45147
    • Recruiting
    • Universitätsklinikum Essen
  • Essen, Germany, 45136
    • Recruiting
    • KEM/Evang. Kliniken Essen Mitte gGmbH
  • Esslingen am Neckar, Germany, 73730
    • Recruiting
    • Klinikum Esslingen
  • Gauting, Germany, 82131
    • Recruiting
    • Asklepios Fachkliniken GmbH
  • Halle, Germany, 06120
    • Recruiting
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
  • Hanover, Germany, 30459
    • Recruiting
    • KRH Klinikum Siloah-Oststadt-Heidehaus
  • Homburg, Germany, 66421
    • Recruiting
    • Universität des Saarlandes
  • Immenhausen, Germany, 34376
    • Recruiting
    • Lungenfachklinik Immenhausen
  • Karlsruhe, Germany, 76137
    • Recruiting
    • Vincentius-Diakonissen-Kliniken gAG
  • Löwenstein, Germany, 74245
    • Recruiting
    • SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
  • Mannheim, Germany, 68167
    • Recruiting
    • Universität Mannheim
  • Oldenburg, Germany, 26121
    • Recruiting
    • Pius Hospital Oldenburg
  • Regensburg, Germany, 93053
    • Recruiting
    • Universitätsklinikum Regensburg
  • Würzburg, Germany, 97074
    • Recruiting
    • Klinikum Würzburg Mitte gGmbH
• Greece
  • Athens, Greece, 115 28
    • Recruiting
    • Alexandras Hospital
  • Athens, Greece, 11526
    • Recruiting
    • Errikos Dynan Hospital
  • Athens, Greece, 115 27
    • Recruiting
    • Sotiria General Hospital of Athens
  • Larissa, Greece, 411 10
    • Recruiting
    • University Hospital of Larissa
  • Thessaloniki, Greece, 546 39
    • Recruiting
    • Interbalkan Medical Center of Thessaloniki
  • Thessaloniki, Greece, 55236
    • Recruiting
    • Ag. Loukas Hospital
  • Thessaloniki, Greece, 54639
    • Recruiting
    • Theageneion Anticancer Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Recruiting
    • Tuen Mun Hospital
  • Kowloon, Hong Kong, 000000
    • Recruiting
    • Queen Elizabeth Hospital Department of Clinical Oncology
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hosp
• Hungary
  • Mátraháza, Hungary, 3233
    • Recruiting
    • Matrai Gyogyintezet
  • Pécs, Hungary, 7623
    • Recruiting
    • Pecsi Tudomanyegyetem
  • Törökbálint, Hungary, 2045
    • Recruiting
    • Reformatus Pulmonologiai Centrum
• Ireland
  • Dublin, Ireland, D09V2N0
    • Recruiting
    • Beaumont Hospital
  • Dublin, Ireland, D24 NR0A
    • Recruiting
    • Tallaght Hospital
  • Dublin, Ireland, D08 NHY1
    • Recruiting
    • St James Hospital
  • Dublin, Ireland, Dublin 7
    • Recruiting
    • Mater Misecordiae University Hospital
• Italy
  • Apulia
    • Statte, Apulia, Italy, 74010
      • Recruiting
      • Ospedale Giuseppe Moscati
  • Campania
    • Naples, Campania, Italy, 80131
      • Recruiting
      • AORN Ospedali dei Colli Ospedale Monaldi
    • Naples, Campania, Italy, 80131
      • Recruiting
      • Istituto Nazionale Tumori Fondazione G. Pascale
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41100
      • Recruiting
      • A.O. Universitaria Policlinico Di Modena
    • Pesaro, Emilia-Romagna, Italy, 61122
      • Recruiting
      • Presidio san salvatore muraglia
  • Friuli Venezia Giulia
    • Aviano, Friuli Venezia Giulia, Italy, 33081
      • Recruiting
      • Irccs Centro Di Riferimento Oncologico (CRO)
  • Lazio
    • Rome, Lazio, Italy, 00151
      • Recruiting
      • Azienda Ospedaliera San Camillo Forlanini
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Policlinico Universitario "Agostino Gemelli"
  • Lombardy
    • Milan, Lombardy, Italy, 20162
      • Recruiting
      • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
    • Milan, Lombardy, Italy, 20141
      • Recruiting
      • IEO Istituto Europeo di Oncologia
    • Monza MI, Lombardy, Italy, 20900
      • Recruiting
      • Azienda Ospedaliera San Gerardo di Monza
  • Sicily
    • Misterbianco (CT), Sicily, Italy, 95045
      • Recruiting
      • Humanitas Centro Catanese Di Oncologia
  • Tuscany
    • Livorno, Tuscany, Italy, 57124
      • Recruiting
      • USL 6 Toscana Nord Ovest ? P.O. Livorno
  • Veneto
    • Peschiera Del Garda (VR), Veneto, Italy, 37019
      • Recruiting
      • Ospedale P. Pederzoli Casa Di Cura Privata
• Japan
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Kyushu University Hospital
  • Fukuoka, Japan, 830-0011
    • Recruiting
    • Kurume University Hospital
  • Hokkaido, Japan, 040-8611
    • Recruiting
    • Hakodate Goryoukaku Hospital
  • Hyōgo, Japan, 663-8501
    • Recruiting
    • Hyogo Medical University Hospital
  • Kagoshima, Japan, 890-8520
    • Recruiting
    • Kagoshima University Hospital
  • Kanagawa, Japan, 241-8515
    • Recruiting
    • Kanagawa Cancer Center
  • Miyagi, Japan, 981-0914
    • Recruiting
    • Sendai Kousei Hospital
  • Niigata, Japan, 951-8520
    • Recruiting
    • Niigata University Medical & Dental Hospital
  • Okayama, Japan, 700-8558
    • Recruiting
    • Okayama University Hospital
  • Osaka, Japan, 545-8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Osaka, Japan, 573-1191
    • Recruiting
    • Kansai Medical University Hospital
  • Sendai, Japan, 980-8574
    • Recruiting
    • Tohoku University Hospital
  • Tokyo, Japan, 135-8550
    • Recruiting
    • The Cancer Institute Hospital Of JFCR
  • Tokyo, Japan, 113-8431
    • Recruiting
    • Juntendo University Hospital
  • Tokyo, Japan, 160-0023
    • Recruiting
    • Tokyo Medical University Hospital
  • Wakayama, Japan, 641-8510
    • Recruiting
    • Wakayama Medical University Hospital
• Mexico
  • Mexico City, Mexico, 06700
    • Recruiting
    • ARKE Estudios Clínicos S.A. de C.V.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Recruiting
      • Hospital Civil de Guadalajara Fray Antonio Alcalde
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Recruiting
    • Ziekenhuis Rijnstate
  • Breda, Netherlands, 4818 CK
    • Recruiting
    • Amphia ziekenhuis
  • Harderwijk, Netherlands, 3844 DG
    • Recruiting
    • Ziekenhuis St. Jansdal
  • Zwolle, Netherlands, 8025 AB
    • Recruiting
    • Isala
  • Utrecht
    • Amersfoort, Utrecht, Netherlands, 3813 TZ
      • Recruiting
      • Meander Medisch Centrum
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Harbour Cancer and Wellness
  • Newtown, New Zealand, 6021
    • Recruiting
    • Wellington Hospital
• Poland
  • Bystra, Poland, 43-360
    • Recruiting
    • Centrum Pulmonologii i Torakochirurgii
  • Gda?sk, Poland, 80-214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 31-202
    • Recruiting
    • Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
  • Lublin, Poland, 20-954
    • Recruiting
    • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
  • Olsztyn, Poland, 10-357
    • Recruiting
    • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
  • Poznan, Poland, 60-569
    • Recruiting
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Radom, Poland, 26-600
    • Recruiting
    • Radomskie Centrum Onkologii
  • Warsaw, Poland, 01-138
    • Recruiting
    • Instytut Gruzlicy i Chorob Pluc
  • Wieliszew, Poland, 05-135
    • Recruiting
    • Mazowiecki Szpital Onkologiczny
  • Wroclaw, Poland, 53-439
    • Recruiting
    • Dolnoslaskie Centrum Chorob Pluc
• Portugal
  • Braga, Portugal, 4710-243
    • Recruiting
    • Hospital de Braga
  • Loures, Portugal, 2674-514
    • Recruiting
    • Hospital Beatriz Angelo
  • Porto, Portugal, 4200-072
    • Recruiting
    • IPO do Porto
  • Vila Nova de Gaia, Portugal, 4434-502
    • Recruiting
    • CHVNG/E_Unidade 1
• Singapore
  • Singapore, Singapore, 119228
    • Recruiting
    • National University Hospital
  • Singapore, Singapore, 168583
    • Recruiting
    • National Cancer Centre
• South Africa
  • Parktown, South Africa
    • Recruiting
    • Wits Donald Gordon Clinical Trial Centre
  • Soweto, South Africa, 2013
    • Recruiting
    • Chris Hani Baragwanath Clinical Trial Site
• South Korea
  • Busan, South Korea, 49241
    • Recruiting
    • Pusan National University Hospital
  • Cheongju-si, South Korea, 28644
    • Recruiting
    • Chungbuk National University Hospital
  • Daegu, South Korea, 41404
    • Recruiting
    • Kyungpook National University Chilgok Hospital
  • Seoul, South Korea, 06591
    • Recruiting
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, South Korea, 110-744
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 8308
    • Recruiting
    • Korea University Guro Hospital
• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic Barcelona
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d Hebron
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Universidad de Navarra Madrid
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Clinico Universitario Virgen de la Victoria
  • Seville, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 07014
      • Recruiting
      • Hospital Universitario Son Espases
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marqués de Valdecilla
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
      • Recruiting
      • Complejo Hospitalario Universitario Insular?Materno Infantil
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Clinica Universitaria de Navarra
• Switzerland
  • Baden, Switzerland, 5404
    • Recruiting
    • Kantonsspital Baden
  • Basel, Switzerland, 4031
    • Recruiting
    • Universitaetsspital Basel
  • Chur, Switzerland, 7000
    • Recruiting
    • Kantonsspital Graubünden Medizin Onkologie
  • Geneva, Switzerland, 1211
    • Recruiting
    • Hôpital Universitaire de Genève (HUG)
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 824
    • Recruiting
    • E-DA Hospital
  • Taichung, Taiwan, 40201
    • Recruiting
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University Hospital
  • Taipei, Taiwan, 00100
    • Recruiting
    • National Taiwan University Hospital
  • Zhongzheng Dist., Taiwan, 106
    • Recruiting
    • National Taiwan University Cancer Center
• United Kingdom
  • Blackpool, United Kingdom, FY3 8NR
    • Recruiting
    • Blackpool Teaching Hospitals NHS Foundation Trust , Victoria Hospital
  • Bristol, United Kingdom, BS2 8ED
    • Recruiting
    • Bristol Haematology & Oncology Centre
  • Canterbury, United Kingdom, CT1 3NG
    • Recruiting
    • East Kent Hospitals University NHS Foundation Trust
  • Cardiff, United Kingdom, CF14 2TL
    • Recruiting
    • Velindre NHS Trust - Velindre Cancer Centre
  • Hull, United Kingdom, HU3 2JZ
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust
  • London, United Kingdom, W1G 6AD
    • Recruiting
    • Sarah Cannon Research Institute
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Royal Marsden Hospital - Fulham
  • London, United Kingdom, E1 2ES
    • Recruiting
    • Barts and The London NHS Trust
  • Maidstone, United Kingdom, ME16 9QQ
    • Recruiting
    • Maidstone and Tunbridge Wells NHS Trust
  • Oxford, United Kingdom, OX3 7LE
    • Recruiting
    • Oxford University Hospitals NHS Trust - Churchill Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden NHS Foundation Trust
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Recruiting
      • Alaska Oncology and Hematology
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Recruiting
      • City of Hope - Phoenix
  • California
    • Greenbrae, California, United States, 94904
      • Recruiting
      • Marin Cancer Care Inc
    • Newport Beach, California, United States, 92658
      • Recruiting
      • Hoag Memorial Hospital
    • Palo Alto, California, United States, 94301
      • Recruiting
      • Palo Alto Medical Foundation Research Center
    • Roseville, California, United States, 95661
      • Recruiting
      • Sutter Institute for Medical Research
    • San Francisco, California, United States, 94115
      • Recruiting
      • California Pacific Medical Center
  • Florida
    • Fort Myers, Florida, United States, 33901-8108
      • Recruiting
      • Florida Cancer Specialists - SOUTH - SCRI - PPDS
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida Health at Shands
    • Hialeah, Florida, United States, 33013
      • Recruiting
      • Bioresearch Partner
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Memorial Healthcare System - Memorial Regional Hospital
    • Miami, Florida, United States, 33136
      • Recruiting
      • Sylvester Comprehensive Cancer Center
    • Pensacola, Florida, United States, 32504
      • Recruiting
      • Ascension Sacred Heart
    • St. Petersburg, Florida, United States, 33701
      • Recruiting
      • Florida Cancer Specialists - NORTH - SCRI - PPDS
    • West Palm Beach, Florida, United States, 33401-3406
      • Recruiting
      • Florida Cancer Specialists - EAST - SCRI - PPDS
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Recruiting
      • Piedmont Cancer Institute, PC
    • Newnan, Georgia, United States, 30265
      • Recruiting
      • City of Hope® Atlanta
    • Savannah, Georgia, United States, 31405
      • Recruiting
      • Summit Cancer Care PC
  • Idaho
    • Boise, Idaho, United States, 83712
      • Recruiting
      • St. Luke's Cancer Institute
  • Illinois
    • Chicago Ridge, Illinois, United States, 60415
      • Recruiting
      • Affiliated Oncologists, LLC
    • Hinsdale, Illinois, United States, 60521
      • Withdrawn
      • Hope and Healing Cancer Services
    • Zion, Illinois, United States, 60099
      • Recruiting
      • City of Hope® Cancer Center Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21229-5201
      • Recruiting
      • Saint Agnes Hospital - Baltimore - Hunt - PPDS
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Recruiting
      • Profound Research, LLC
  • Missouri
    • St Louis, Missouri, United States, 63131
      • Recruiting
      • Missouri Baptist Medical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • NHO Revive Research Institute
  • New Mexico
    • Farmington, New Mexico, United States, 87401
      • Recruiting
      • San Juan Oncology Associates
  • New York
    • The Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Einstein Cancer Center
    • Westbury, New York, United States, 11590
      • Recruiting
      • Clinical Research Alliance
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Recruiting
      • FirstHealth of the Carolinas
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Recruiting
      • St. Luke's University Health Network
    • West Reading, Pennsylvania, United States, 19611
      • Recruiting
      • Reading Hospital - McGlinn Cancer Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Baptist Cancer Center
  • Texas
    • El Paso, Texas, United States, 79915
      • Recruiting
      • Renovatio Clinical - El Paso
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • JPS Health Network
    • Houston, Texas, United States, 77030-4000
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
    • Kingwood, Texas, United States, 77339
      • Recruiting
      • Community Clinical Trials
    • Lubbock, Texas, United States, 79415
      • Recruiting
      • Texas Tech Health Science Center
    • The Woodlands, Texas, United States, 77380
      • Recruiting
      • Renovatio Clinical
    • Tyler, Texas, United States, 75708
      • Recruiting
      • University of Texas Health Center at Tyler
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria Related to NSCLC:

• Known concomitant second oncogenic driver with available targeted treatment
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization
• History of leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)

Exclusion Criteria Related to Current or Prior Treatments:

• Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study
• Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung >30Gy within 6 months prior to randomization
• Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
• Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors
• Current treatment with medications that are well known to prolong the QT interval
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization
• Prior allogeneic stem cell or solid organ transplantation

Exclusion Criteria Related to General Health:

• History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival [OS] rate >90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
• Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
• Significant cardiovascular disease within 3 months prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Divarasib + Pembrolizumab; Participants will receive divarasib orally, once daily (QD) and pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W)	Drug: Divarasib; Divarasib will be administered orally QD; Drug: Pembrolizumab; Pembrolizumab will be administered via IV infusion Q3W
Active Comparator: Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin; Participants will receive pembrolizumab, pemetrexed and carboplatin or cisplatin via IV infusion Q3W	Drug: Pembrolizumab; Pembrolizumab will be administered via IV infusion Q3W; Drug: Pemetrexed; Pemetrexed will be administered via IV infusion Q3W; Drug: Carboplatin; Carboplatin will be administered via IV infusion Q3W; Drug: Cisplatin; Cisplatin will be administered via IV infusion Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)	Up to approximately 5 years
Overall Survival (OS)	OS is defined as the time from randomization to death from any cause	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response	Objective response is defined as complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by BICR according to RECIST v1.1	Up to approximately 5 years
Change from Baseline on the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (EORTC QLQ-LC13) Cough Scale		Baseline up to Cycle 5 Day 1 (each cycle is 21 days)
Change from Baseline on the EORTC Quality of Life Questionnaire (QLQ-C30) Dyspnea Item and Physical Functioning Scale		Baseline up to Cycle 5 Day 1 (each cycle is 21 days)
Duration of Response (DOR)	DOR is defined as the time from the first occurrence of a documented objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)	Up to approximately 5 years
Percentage of Participants with Adverse Events (AEs)		Up to approximately 5 years
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)		Up to approximately 5 years
Change from Baseline in the Severity of Selected Symptomatic Treatment Toxicities as Assessed Through use of the NCI PRO-CTCAE		Up to approximately 5 years
Frequency of Participants' Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the single-item EORTC Item List (IL46)		Up to approximately 5 years
Change from Baseline on the EORTC QLQ-C30 and QLQ-LC13 Functional and Global Health Status Score/Quality of Life Score (GHS/QoL)		Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Chugai Pharmaceutical
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): October 31, 2030

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Lung Cancer; Metastatic lung cancer; Advanced Non-Small Cell Lung Cancer; Lung Cancer Mutation; KRAS Mutation; KRAS G12 Lung Cancer; Divarasib; KRAS G12C Inhibitor; KRAS G12C Positive; KRAS G12C Mutation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Pemetrexed; Carboplatin; Cisplatin; pembrolizumab
• Other Study ID Numbers: CO45042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No