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
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.
• 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