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
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) expressio…
Interventions
- DrugOlomorasib
Administered orally.
- DrugPembrolizumab
Administered intravenously (IV).
- DrugDurvalumab
Administered IV.
- DrugPlacebo
Administered orally.
Locations (355)
- Clearview Cancer InstituteHuntsville, Alabama
- Infirmary Cancer CareMobile, Alabama
- The University of Arizona Cancer Center - North CampusTucson, Arizona
- Highlands Oncology GroupSpringdale, Arkansas
- UCLA Hematology/Oncology - Santa MonicaLos Angeles, California
- Profound Research LLCOceanside, California