JZQH

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Double-Blind, 2-part Study in Participants with KRAS G12C-Mutant, Non-Small Cell Lung Cancer Comparing the Efficacy and Safety of Olomorasib in Combination with Standard of Care to Placebo in Combination with Standard of Care as Adjuvant Treatment after Platinum-based Chemotherapy - SUNRAY-02​

• IRAS ID

  1009983

• Contact name

  Maryna Kvochka

• Contact email

  EU_lilly_clinical_trials@lilly.com

• Sponsor organisation

  Eli Lilly and Company

• Research summary

  Part A is a randomised, double-blind, placebo-controlled part of the study comparing the efficacy and safety of olomorasib in combination with pembrolizumab to placebo in combination with pembrolizumab in participants with resected KRAS G12C mutant Stage II-IIIB NSCLC.​
  Part B is a randomised, double-blind, placebo-controlled part of the study comparing the efficacy and safety of olomorasib in combination with durvalumab to placebo with durvalumab as consolidation treatment in participants with unresectable Stage III KRAS G12C-mutant NSCLC whose disease has not progressed following definitive, platinum-based, concurrent chemoradiation therapy.​
  Part A will randomise approximately 400 participants.
  Part B will randomise approximately 300 participants.
  In Part A, participants will be randomly assigned in a 1:1 ratio to either olomorasib in combination with pembrolizumab or placebo in combination with pembrolizumab.
  In Part B, participants will be randomly assigned in a 1:1 ratio to either olomorasib in combination with durvalumab or placebo in combination with durvalumab.
  Participants will receive combination treatment for up to approximately 1 year, followed by olomorasib or placebo monotherapy to complete up to 3 years of total treatment.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  25/ES/0011

• Date of REC Opinion

  6 Mar 2025

• REC opinion

  Further Information Favourable Opinion