Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With
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
| Condition(s) | Carcinoma, Non-Small-Cell Lung |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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) 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 participat |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Eli Lilly and Company |
| Locations | Huntsville, Alabama, United States; Mobile, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Springdale, Arkansas, United States; Los Angeles, California, United States (+355 more sites) |
| Start date | 2025-03-27 |
| NCT ID | NCT06890598 |
| Official listing | https://clinicaltrials.gov/study/NCT06890598 |