NCT06890598PHASE3RECRUITING

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02

Sponsor: Eli Lilly and Company + AstraZeneca

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Olomorasib, Pembrolizumab, Durvalumab, Placebo

Enrollment

700 participants

Primary completion

May 2029

Study completion

Feb 2032

First posted

Mar 2025

Last updated

May 2026

Primary Endpoints (CT.gov)

Part A: Disease-Free Survival (DFS) by Investigator Assessment

Time frame: Randomization to disease recurrence or death from any cause (Estimated as approximately 48 months).

Part B: Progression-Free Survival (PFS)

Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).

Secondary Endpoints

Part A & B: Overall Survival (OS)

Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30 (EORTC QLQ-C30)

Part B: PFS

Eligibility Criteria

Inclusion Criteria: * Histological or cytological confirmation of NSCLC. * Part A 1. Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible. 2. Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection. * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy. * Must have disease with evidence of KRAS G12C mutation. * Must have known programmed death-ligand 1 (PD-L1) expression * Must have an ECOG performance status of 0 or 1. * Able to swallow oral medication. * Must have adequate laboratory parameters. * Contraceptive use should be consistent with local regulations for those participating in clinical studies. * Women of childbearing potential must * Have a negative pregnancy test. * Not be breastfeeding during treatment Exclusion Criteria: * Have known changes…

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov