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A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Hoffmann-La Roche
Summary
The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.
Official title: A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-10-06
Completion Date
2035-03-31
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Divarasib
Divarasib will be administered orally as per the schedule specified in the respective arm.
Pembrolizumab
Pembrolizumab will be administered as either a 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) or 395 mg subcutaneous (SC) injection Q3W, for up to 13 cycles (1 cycle = 21 days).
Nivolumab
Nivolumab will be administered as either a 480 mg IV infusion, every 4 weeks (Q4W) or 1200 mg SC injection Q4W, for up to 13 cycles (1 cycle = 28 days).
Locations (46)
Community Cancer Institute (CCI)
Clovis, California, United States
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States
Profound Research, LLC
Farmington Hills, Michigan, United States
Renown Regional Medical Center
Reno, Nevada, United States
Cancer Care Specialists
Reno, Nevada, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Sanatorio de la Mujer
Rosario, Santa Fe Province, Argentina
Instituto Argentino de Diagnóstico y Tratamiento- IADT
Capital Federal, Argentina
Hospital Britanico
Ciudad Autonoma Buenos Aires, Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina
Hospital Privado De Comunidad
Mar del Plata, Argentina
Cenantron - Centro Avancado de Tratamento Oncologico
Belo Horizonte, Minas Gerais, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo, Brazil
Jewish General Hospital
Montreal, Quebec, Canada
Guangdong General Hospital
Guangzhou, China
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., Colombia
Clinica ASTORGA
Medellín, Colombia
Attikon University General Hospital
Athens, Greece
Athens Medical Center
Marousi, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hosp
Shatin, Hong Kong
Ospedale P. Pederzoli Casa di cura Privata
Peschiera Del Garda (VR), Veneto, Italy
Gifu University Hospital
Gifu, Japan
Kobe University Hospital
Hyōgo, Japan
Centrum Pulmonologii i Torakochirurgii
Bystra, Poland
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Gda?sk, Poland
?wi?tokrzyskie Centrum Onkologii Samodzielny Publiczny Zak?ad Opieki Zdrowotnej w Kielcach;Klinika Onkologii Klinicznej
Kielce, Poland
Centro Clinico Champalimaud
Lisbon, Portugal
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Pusan National University Hospital
Busan, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Ajou University Medical Center
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital de Basurto
Bilbao, Vizcaya, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Hospital General Univ. de Alicante
Alicante, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain