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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 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Placebo
- DRUG Cisplatin
- DRUG LY3537982
Study Locations (20)
Florida
- Millennium Oncology Research Clinic — Hollywood
- University of Florida - Jacksonville — Jacksonville
- Miami Cancer Institute at Baptist Health, Inc. — Miami
- Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala — Ocala
- Comprehensive Hematology Oncology — St. Petersburg
California
- Cedars-Sinai Medical Center — Los Angeles
- Mercy Cancer Center — Merced
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
- BASS Cancer Center — Walnut Creek
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Banner University Medical Center Phoenix — Phoenix
- The University of Arizona Cancer Center - North Campus — Tucson
Georgia
- University Cancer & Blood Center, LLC — Athens
- Emory University School of Medicine- Grady Campus — Atlanta
- Winship Cancer Institute, Emory University — Atlanta
Alabama
- Clearview Cancer Institute — Huntsville
Arkansas
- Highlands Oncology Group — Springdale
Colorado
- USO - Rocky Mountain Cancer Centers — Lone Tree
Connecticut
- Yale University School of Medicine — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,264 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2031-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06119581
The ClinicalTrials.gov registry entry for NCT06119581 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06119581 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06119581 about?
NCT06119581 is a clinical study titled "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". 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 fo...
What is the current status of trial NCT06119581?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,264 participants. The study started on 2023-12-21. Estimated completion is 2031-01.
What conditions does trial NCT06119581 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06119581?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Placebo (DRUG), Cisplatin (DRUG), LY3537982 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06119581?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06119581 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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