RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07541170

Registry updated: 2026-10-13

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Description

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.

Interventions

Divarasib (Drug)
Divarasib will be administered orally as per the schedule specified in the respective arm.
Pembrolizumab (Drug)
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 (Drug)
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).

Eligibility criteria

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology * Participants must have had complete resection of NSCLC * Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy * Participants must be randomized within 12 weeks of their surgery date * No evidence of disease recurrence or metastatic disease * Documentation of the presence of a KRAS G12C mutation Exclusion Criteria: * Participants who achieve pCR following neoadjuvant treatment * Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol * Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection * Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy * Active or history of autoimmune disease or immune deficiency * Significant cardiovascular disease

Conditions

Non-small Cell Lung Cancer

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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