Phase 2 Trial of Adagrasib Alone and With Pembrolizumab and Phase 3 Trial Comparing Adagrasib Plus Pembrolizumab Versus Pembrolizumab in Advanced NSCLC With KRAS G12C Mutation

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Adagrasib MRTX849 alone and combined with pembrolizumab in patients with advanced non-small cell lung cancer NSCLC who have the KRAS G12C mutation. The study includes a Phase 2 portion focusing on patients with various PD-L1 scores and a Phase 3 portion comparing Adagrasib plus pembrolizumab versus pembrolizumab alone in patients with high PD-L1 levels. This research aims to improve first-line treatment options for advanced NSCLC. The Phase 2 study has three groups two cohorts with low PD-L1 scores receiving either Adagrasib alone or combined with pembrolizumab, and one cohort with higher PD-L1 scores receiving the combination. In Phase 3, patients are randomly assigned to receive either Adagrasib with pembrolizumab or pembrolizumab alone. Adagrasib is taken orally twice daily, while pembrolizumab is given by intravenous infusion every three weeks. Participants will undergo regular assessments over 22 months for Phase 2 and 36 months for Phase 3, including evaluations of tumor response, safety, quality of life, and drug levels in the blood. Brain imaging is also used to check for metastases. Researchers will monitor progression-free survival, duration of response, and side effects to understand the treatments impact and tolerability throughout the study period.

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7