A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT06119581

Run by

Eli Lilly and Company

People needed

1264

Starts

2023-12-21

Expected to finish

2031-01-01

Last updated by the study team

2026-07-20

Who can join

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

You may qualify if…

• 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 ECOG performance status of 0 or 1.
• Estimated life expectancy ≥12 weeks.
• Ability to swallow capsules.
• 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 a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3.
• Have had any of the following prior to randomization:
• - Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.
• -- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:
• Have known active central nervous system metastases and/or carcinomatous meningitis.
• Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)
• Have predominantly squamous cell histology for NSCLC
• Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed
• Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Where it is running

• Franciscan Health — Indianapolis, Indiana, United States (enrolling)
• Clearview Cancer Institute — Huntsville, Alabama, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Banner University Medical Center Phoenix — Phoenix, Arizona, United States (enrolling)
• The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States (enrolling)
• USO - Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Millennium Oncology Research Clinic — Hollywood, 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)
• BASS Cancer Center — Walnut Creek, California, United States (enrolling)
• Comprehensive Hematology Oncology — St. Petersburg, Florida, United States (enrolling)
• University Cancer & Blood Center, LLC — Athens, Georgia, United States (enrolling)
• Emory University School of Medicine- Grady Campus — Atlanta, Georgia, United States (enrolling)
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (enrolling)
• University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
• University of Chicago Hospital — Chicago, Illinois, United States (enrolling)
• Springfield Clinic Main Campus — Springfield, Illinois, United States (enrolling)
• Parkview Research Center at Parkview Regional Medical Center — Fort Wayne, Indiana, United States (enrolling)
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Community Cancer Center North — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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