SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
Eli Lilly and Company
Summary
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.
Description
Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized. Part C is non-randomized.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. * Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label). * Must have disease with evidence of KRAS G12C mutation. * Must have known programmed death-ligand 1 (PD-L1) expression * Part A: Greater than or equal to (≥)50 percent (%). * Part B: 0% to 100%. * Part C: \<50%. * Must have measurable disease per RECIST v1.1. * Must have an EC…
Interventions
- DrugLY3537982
Administered orally.
- DrugPembrolizumab
Administered IV.
- DrugPlacebo
Administered orally.
- DrugCisplatin
Administered IV.
- DrugCarboplatin
Administered IV.
- DrugPemetrexed
Administered IV.
Locations (422)
- Clearview Cancer InstituteHuntsville, Alabama
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Banner University Medical Center PhoenixPhoenix, Arizona
- The University of Arizona Cancer Center - North CampusTucson, Arizona
- Highlands Oncology GroupSpringdale, Arkansas
- Cedars-Sinai Medical CenterLos Angeles, California