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RecruitingLast updated: 22 December 2025

SUNRAY-02: This study is recruiting people with non-small cell lung cancer with a KRAS G12C mutation to evaluate if combinations of targeted therapy and immunotherapy are more effective than immunotherapy aloneA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

SUNRAY-02

Clinical summary

Summary

This study is evaluating whether olomorasib targeted therapy in combination with immunotherapy (either pembrolizumab or durvalumab) is more effective than immunotherapy in combination with a placebo in people with KRAS G12C-mutant non-small cell lung cancer (NSCLC). 

The study has two parts.

Part A will enrol people whose cancer has been, or is able to be, removed with surgery (resected), and participants will be randomly allocated to one of two treatment arms.

Participants will receive either olomorastib targeted therapy or a placebo, both given orally, in combination with pembrolizumab immunotherapy administered intravenously (via IV) for up to 1 year, followed by either further olomorastib or placebo alone for up to 3 years of total treatment.

Part B will enrol people whose cancer is unable to be removed with surgery (unresectable), and participants will be randomly allocated to one of two treatment arms.

Participants will receive either olomorastib targeted therapy or a placebo, both given orally, in combination with durvalumab immunotherapy administered IV for up to 1 year, followed by either further olomorastib or placebo alone for up to 3 years of total treatment. 

 

 

Conditions

This trial is treating people with non-small cell lung cancer that has a KRAS G12C mutation

Eligibility

Inclusion

  • 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

  • Have known changes in the EGFR or ALK genes.
  • Have another type of cancer that is progressing or required active treatment within the past 3 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.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Eli Lilly and Company

Scientific Title

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

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