Phase III Study Comparing Divarasib With Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C Positive Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of divarasib compared with investigators choice of immunotherapy pembrolizumab or nivolumab or observation in participants with resected Stage II-IIIB non-small cell lung cancer NSCLC that has a KRAS G12C mutation. This study focuses on patients who have not achieved a complete pathological response after neoadjuvant chemoimmunotherapy, regardless of their tumors PD-L1 status. The purpose is to understand which treatment approach may better prevent disease recurrence or death. Participants will be randomly assigned to one of two groups. One group will receive divarasib, taken orally once daily for up to 52 cycles, with each cycle lasting 21 days. The other group will receive either pembrolizumab or nivolumab, depending on prior treatment, or undergo observation without additional study treatment. Pembrolizumab is given as an intravenous infusion or subcutaneous injection every three weeks for up to 13 cycles. Nivolumab is administered intravenously or subcutaneously every four weeks for up to 13 cycles. During the study, participants will be monitored regularly to assess disease-free survival, which measures the time from randomization to disease recurrence or death for up to approximately five years. Other outcomes include overall survival and adverse event tracking for up to eight years. Participants will undergo evaluations including clinical assessments and safety monitoring throughout the treatment and follow-up period, which may last several years in total.

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)