SUNRAY-02: A Phase 3 Study of Olomorasib and Immunotherapy in Stage II-III KRAS G12C-Mutant NSCLC

Background: Olomorasib is a highly selective 2 nd - generation KRAS G12C inhibitor. The phase 1/2 LOXO-RAS-20001 study showed that olomorasib alone and with pembrolizumab (pembro) demonstrated efficacy and a favorable safety profile in patients with advanced NSCLC. Methods: SUNRAY-02 is a global, randomized, phase 3 study that aims to determine the efficacy of olomorasib with standard of care immunotherapy following definitive treatment (tx) of stage II-III NSCLC. Eligible participants are≥18 years, ECOG PS 0-1, with pathological confirmation of NSCLC with known KRAS G12C mutation and PD-L1 expression (0-100%). Exclusion criteria: EGFR mutation or ALK rearrangement, prior history of NSCLC, pneumonitis/interstitial lung disease requiring steroids, or active autoimmune disease. This study includes two parts: Part A will enroll ~400 participants with resected stage II-IIIB NSCLC, who received neoadjuvant chemoimmunotherapy without achieving a pathological complete response or adjuvant chemotherapy. Part A participants will be randomized 1:1 to either olomorasib+pembro or placebo (pbo)+pembro. Primary endpoint: disease-free survival. Part B will enroll ~300 participants with unresectable stage III NSCLC with no evidence of disease progression following concurrent chemoradiation. Part B participants will be randomized 1:1 to receive either olomorasib+durvalumab or pbo+durvalumab. Primary endpoint: progression-free survival by blinded independent central review. All participants will receive combination tx for up to ~1 year, followed by olomorasib or pbo monotherapy to complete up to 3 years of total tx. Publication History Article published online: 04 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany