WCLC 2025 - Posters & ePosters-P3.18.09 SUNRAY-02: A Phase 3 Study of Olomorasib and Immunotherapy in Stage II-III KRAS G12C-Mutant NSCLC After Definitive Therapy

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The SUNRAY-02 is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of olomorasib combined with standard-of-care (SOC) immunotherapy in patients with stage II-III non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations after definitive treatment. The study addresses the significant clinical challenge that up to two-thirds of early-stage NSCLC patients experience disease recurrence and progression despite current adjuvant therapies.<br /><br />SUNRAY-02 comprises two cohorts: Part A includes 400 patients with resected stage II-IIIB NSCLC who received neoadjuvant chemoimmunotherapy without complete pathological response or adjuvant chemotherapy; Part B includes 300 patients with unresectable stage III NSCLC showing no progression after concurrent chemoradiation. Participants are randomized 1:1 to receive either olomorasib orally twice daily for up to three years plus pembrolizumab (Part A) or durvalumab (Part B) for approximately one year, or placebo plus the respective immunotherapy.<br /><br />Primary endpoints are disease-free survival (DFS) by investigator assessment in resected NSCLC and progression-free survival (PFS) per blinded independent central review (BICR) in unresectable NSCLC. Secondary endpoints include overall survival (OS), safety assessed by CTCAE v5.0, patient-reported outcomes, and additional efficacy metrics such as objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and time to response (TTR).<br /><br />Olomorasib is a potent, selective second-generation KRAS G12C inhibitor showing promising antitumor activity and manageable safety in prior phase 1/2 studies in advanced NSCLC. SUNRAY-02 aims to assess whether adding olomorasib to established immunotherapies (pembrolizumab or durvalumab) improves outcomes in the curative setting.<br /><br />Key eligibility criteria include adults with ECOG performance status 0-1, confirmed KRAS G12C mutation, and no concurrent EGFR/ALK alterations or active autoimmune or interstitial lung diseases. The trial operates across 29 countries. The study is sponsored by Eli Lilly and Company, who also provided medical writing support.<br /><br />In summary, SUNRAY-02 investigates whether combining olomorasib with SOC immunotherapy can better prevent recurrence or progression in stage II-III KRAS G12C-mutant NSCLC after definitive therapy compared to SOC alone, potentially offering a novel treatment paradigm for this patient population.

Asset Subtitle

Ernest Nadal

Meta Tag

Speaker Ernest Nadal

Topic Clinical Trials in Progress

Keywords

SUNRAY-02

olomorasib

KRAS G12C mutation

non-small cell lung cancer

NSCLC

immunotherapy

pembrolizumab

durvalumab

phase 3 clinical trial

disease-free survival