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Clinical Trials in the UK / NCT06119581
Recruiting Phase 3

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

NCT06119581 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2023-12-21
Last updated
2026-09-08

Condition(s) studied

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis

Investigational drug(s) / intervention(s)

LY3537982PembrolizumabPlaceboCisplatinCarboplatinPemetrexed

LY3537982: Administered orally.

Pembrolizumab: Administered IV.

Placebo: Administered orally.

Cisplatin: Administered IV.

Carboplatin: Administered IV.

Pemetrexed: Administered IV.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (418)

FacilityCityRegionStatus
Clearview Cancer Institute Huntsville Alabama Recruiting
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
Banner University Medical Center Phoenix Phoenix Arizona Recruiting
The University of Arizona Cancer Center - North Campus Tucson Arizona Recruiting
Highlands Oncology Group Springdale Arkansas Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California Completed
BASS Cancer Center Walnut Creek California Recruiting
USO - Rocky Mountain Cancer Centers Lone Tree Colorado Recruiting
Yale University School of Medicine New Haven Connecticut Recruiting
Sibley Memorial Hospital Washington D.C. District of Columbia Recruiting
Millennium Oncology Research Clinic Hollywood Florida Recruiting
University of Florida - Jacksonville Jacksonville Florida Recruiting
Miami Cancer Institute at Baptist Health, Inc. Miami Florida Recruiting
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala Ocala Florida Recruiting
Orlando Health Cancer Institute Orlando Florida Recruiting
Comprehensive Hematology Oncology St. Petersburg Florida Recruiting
University Cancer & Blood Center, LLC Athens Georgia Recruiting
Emory University School of Medicine- Grady Campus Atlanta Georgia Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia Recruiting
University of Illinois at Chicago Chicago Illinois Recruiting
University of Chicago Hospital Chicago Illinois Recruiting
Springfield Clinic Main Campus Springfield Illinois Recruiting
Parkview Research Center at Parkview Regional Medical Center Fort Wayne Indiana Recruiting
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana Recruiting
Franciscan Health Indianapolis Indiana Recruiting
Community Cancer Center North Indianapolis Indiana Recruiting
The University of Kansas Cancer Center - Westwood Westwood Kansas Recruiting
CHI Saint Joseph Cancer Center - East Lexington Kentucky Recruiting
University of Kentucky Chandler Medical Center Lexington Kentucky Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Recruiting
Johns Hopkins Bayview Medical Center Baltimore Maryland Recruiting
USO - Maryland Oncology Hematology Columbia Maryland Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Lahey Hospital & Medical Center Burlington Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
The Cancer & Hematology Centers Grand Rapids Michigan Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital Minneapolis Minnesota Recruiting
HealthPartners Cancer Research Center Saint Paul Minnesota Recruiting
North Mississippi Hematology and Oncology Associates Tupelo Mississippi Recruiting

+ 378 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06119581 on ClinicalTrials.gov ↗ ← All trials in the UK