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Phase 3Recruiting

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

Sponsored by Eli Lilly and Company

About this study

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.

Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized. Part C is non-randomized.

Where this study is enrolling (37)

  • Clearview Cancer Institute

    Huntsville, Alabama

    Call 256-705-4224

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  • Banner MD Anderson Cancer Center

    Gilbert, Arizona

    Call +1 480-256-6444

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  • The University of Arizona Cancer Center - North Campus

    Tucson, Arizona

    Call 520-626-3434

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  • Highlands Oncology Group

    Springdale, Arkansas

    Call 479-872-8130

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  • USO - Rocky Mountain Cancer Centers

    Lone Tree, Colorado

    Call 303-925-0700

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Show all 37 locations

  • Yale University School of Medicine

    New Haven, Connecticut

    Call 475-306-2658

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  • Millennium Oncology Research Clinic

    Hollywood, Florida

    Call 954-450-1808

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  • Comprehensive Hematology Oncology

    St. Petersburg, Florida

    Call 727-344-6569

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  • University of Florida - Jacksonville

    Jacksonville, Florida

    Call 904-244-4292

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  • Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala

    Ocala, Florida

    Call 352-732-4032

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  • Emory University School of Medicine- Grady Campus

    Atlanta, Georgia

    I'm interested

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia

    I'm interested

  • University Cancer & Blood Center, LLC

    Athens, Georgia

    Call 706-353-2990

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  • University of Chicago Hospital

    Chicago, Illinois

    Call 773-702-9901

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  • Franciscan Health

    Indianapolis, Indiana

    Call 317-859-5252

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  • Community Cancer Center North

    Indianapolis, Indiana

    Call 317-621-3858

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  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas

    Call 913-588-6029

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  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky

    Call 859-257-9568

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  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana

    Call 225-215-1185

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  • Boston Medical Center

    Boston, Massachusetts

    Call 617-638-7584

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  • Lahey Hospital & Medical Center

    Burlington, Massachusetts

    Call 781-744-8400

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  • Oncology Hematology Associates

    Springfield, Missouri

    Call 417-882-4880

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  • Laura and Isaac Perlmutter Cancer Center

    New York, New York

    Call 212-731-6363

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  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York

    Call 212-731-6363

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  • Maimonides Cancer Center

    Brooklyn, New York

    Call 718-765-2600

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  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T

    Columbus, Ohio

    Call 614-293-3300

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  • Kaiser Permanente Interstate Medical Office Central

    Portland, Oregon

    Call 503-249-3315

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  • Asante Rogue Regional Medical Center

    Medford, Oregon

    Call 541-789-5003

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  • USO - Oncology Associates of Oregon

    Eugene, Oregon

    Call 541-683-5001

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  • Lexington Medical Center

    West Columbia, South Carolina

    Call 803-794-7511

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  • University of Tennessee Medical Center

    Knoxville, Tennessee

    Call 865-305-8780

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  • University of Texas MD Anderson Cancer Center

    Houston, Texas

    Call 877-632-6789

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  • Houston Methodist Hospital

    Houston, Texas

    Call 713.790.3311

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  • William Beaumont Army Medical Center

    Fort Bliss, Texas

    Call 915-203-2268

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  • Lumi Research

    Houston, Texas

    I'm interested

  • University of Virginia Health System

    Charlottesville, Virginia

    Call 434-924-4251

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  • VCU Health Adult Outpatient Pavillion

    Richmond, Virginia

    Call 804-828-7999

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.