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Combining Olomorasib with Standard Treatments for KRAS G12C-mutant 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

Phase 3 Interventional Eli Lilly and Company · NCT06890598

This study is testing if adding olomorasib to standard treatments can help people with KRAS G12C-mutant lung cancer do better than with the usual care alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsimmunotherapy, pembrolizumab, durvalumab
Locations354 sites (Huntsville, Alabama and 353 other locations)
Trial IDNCT06890598 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of olomorasib when combined with pembrolizumab in patients with resected KRAS G12C-mutant non-small cell lung cancer (NSCLC) and with durvalumab in those with unresectable KRAS G12C-mutant NSCLC. Participants will be assigned to one of two parts based on their cancer stage and treatment history. The study aims to determine if these combinations provide better outcomes compared to standard treatments with placebo. Each participant may be involved in the study for up to three years.

Who should consider this trial

Good fit: Ideal candidates include individuals with confirmed KRAS G12C mutation and specific stages of non-small cell lung cancer, either resected or unresectable.

Not a fit: Patients without the KRAS G12C mutation or those with a pathologic complete response after initial treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with KRAS G12C-mutant non-small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and immunotherapies in lung cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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 in the EGFR or ALK genes.
* Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
* Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.

Where this trial is running

Huntsville, Alabama and 353 other locations

+304 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell Lung
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.