drugset / Trial / NCT07541170

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)

NCT07541170

Phase 3 Not yet recruiting 400 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-09-01
Primary completion
2032-01-31
Completion
2035-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Divarasib Small molecule Oral
Comparator Nivolumab Monoclonal antibody 480 mg Intravenous
Comparator Nivolumab Monoclonal antibody 1200 mg Intravenous
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous
Comparator Pembrolizumab Monoclonal antibody 395 mg Intravenous