Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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 facts

Study ID

NCT06890598

Run by

Eli Lilly and Company

People needed

700

Starts

2025-03-27

Expected to finish

2032-02-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Have known, actionable 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.

Where it is running

• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Franciscan Health — Indianapolis, Indiana, United States (enrolling)
• Clearview Cancer Institute — Huntsville, Alabama, United States (enrolling)
• University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
• Parkview Research Center at Parkview Regional Medical Center — Fort Wayne, Indiana, United States (enrolling)
• Profound Research LLC — Oceanside, California, United States (enrolling)
• The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States (enrolling)
• Stanford Cancer Center — Palo Alto, California, United States (enrolling)
• Kaiser Permanente San Diego Mission Road — San Diego, California, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• Springfield Clinic Main Campus — Springfield, Illinois, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Boca Raton Regional Hospital — Boca Raton, Florida, United States (enrolling)
• Florida Cancer Specialists - South — Fort Myers, Florida, United States (enrolling)
• University of Florida - Jacksonville — Jacksonville, Florida, United States (enrolling)
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (enrolling)
• Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala — Ocala, Florida, United States (enrolling)
• Florida Cancer Specialists North — St. Petersburg, Florida, United States (enrolling)
• Comprehensive Hematology Oncology — St. Petersburg, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Florida Cancer Specialists East — West Palm Beach, Florida, United States (enrolling)
• BASS Cancer Center — Walnut Creek, California, United States (enrolling)
• Hartford Hospital (HH) — Hartford, Connecticut, United States (enrolling)
• Captain James A. Lovell Federal Health Care Center — North Chicago, Illinois, United States (enrolling)
• Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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