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RECRUITING
NCT07541170
PHASE3

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

View on ClinicalTrials.gov

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

2026-09-30

Completion Date

2035-03-31

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Divarasib

Divarasib will be administered orally as per the schedule specified in the respective arm.

DRUG

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).

DRUG

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 (19)

Community Cancer Institute (CCI)

Clovis, California, United States

Piedmont Cancer Institute, PC

Atlanta, Georgia, United States

Profound Research, LLC

Farmington Hills, Michigan, 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

Cenantron - Centro Avancado de Tratamento Oncologico

Belo Horizonte, Minas Gerais, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

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

Pusan National University Hospital

Busan, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea