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.
Histological or cytological confirmation of NSCLC.
Part A
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.
Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection.
Have known changes in the EGFR or ALK genes.
Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.
Eli Lilly and Company
Lead sponsor
AstraZeneca
Collaborator