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

Description
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

Objective
Part A
Primary Objective:
1. To compare the efficacy of olomorasib in combination with pembrolizumab versus placebo with pembrolizumab

Secondary Objective:
1. To compare olomorasib in combination with pembrolizumab versus placebo with pembrolizumab for the following measures: efficacy, changes in HRQoL, safety, patient-reported tolerability.

Part B
Primary Objective:
1. To compare the efficacy of olomorasib in combination with durvalumab versus placebo with durvalumab.

Secondary Objective:
1. To compare olomorasib in combination with durvalumab versus placebo with durvalumab for the following measures: efficacy, safety, changes in patient-reported NSCLCrelated symptoms, changes in HRQoL, patient-reported tolerability.

Treatment The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Key Eligibility Inclusion Criteria:

Histological or cytological confirmation of NSCLC.



Part A



Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.

Pathologic Stage II-IIIB (N0, N1, 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

Applicable Disease Sites
Lung

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital