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
NCT ID: NCT06793215
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2025-10-24
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Divarasib + Pembrolizumab
Participants will receive divarasib orally, once daily (QD) and pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W)
Divarasib
Divarasib will be administered orally QD
Pembrolizumab
Pembrolizumab will be administered via IV infusion Q3W
Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin
Participants will receive pembrolizumab, pemetrexed and carboplatin or cisplatin via IV infusion Q3W
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
* 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
* 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
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alaska Oncology and Hematology
Anchorage, Alaska, United States
Marin Cancer Care Inc
Greenbrae, California, United States
BioResearch Partner
Hialeah, 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
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
Clinical Research Alliance
Westbury, New York, 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
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle
Warath, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Jessa Zkh (Campus Virga Jesse)
Hasselt, , 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
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
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Centre Hospitalier Regional De Rimouski
Rimouski, Quebec, Canada
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Shanghai East Hospital
Shanghai, , China
Aarhus Universitetshospital
Aarhus N, , Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, , Denmark
CHU Montpellier
Montpellier, , France
Groupe Hospitalier Paris Saint Joseph
Paris, , France
CH de Saint Quentin
Saint-Quentin, , 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
Universitätsklinikum Essen
Essen, , Germany
Klinikum Esslingen
Esslingen am Neckar, , 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
Universitätsklinikum Regensburg
Regensburg, , Germany
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
Reformatus Pulmonologiai Centrum
Törökbálint, , Hungary
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, 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
Amphia Ziekenhuis
Breda, , Netherlands
Ziekenhuis St. Jansdal
Harderwijk, , 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
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
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
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
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
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Bristol Haematology & Oncology Centre
Bristol, , United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, , United Kingdom
Barts and the London NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: CO45042 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
Other Identifiers
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CO45042
Identifier Type: -
Identifier Source: org_study_id