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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
RecruitingPhase 3
SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the 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.
What is being tested
- LY3537982 (drug)
- Pembrolizumab (drug)
- Placebo (drug)
- Cisplatin (drug)
- Carboplatin (drug)
- Pemetrexed (drug)
Sponsor: Eli Lilly and Company · Participants: 1,264 · Started: Dec 21, 2023
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT06119581
Locations in the U.S.
| Alabama | Clearview Cancer Institute, Huntsville |
| Arizona | Banner MD Anderson Cancer Center, Gilbert Banner University Medical Center Phoenix, Phoenix The University of Arizona Cancer Center - North Campus, Tucson |
| Arkansas | Highlands Oncology Group, Springdale |
| California | Cedars-Sinai Medical Center, Los Angeles BASS Cancer Center, Walnut Creek |
| Colorado | USO - Rocky Mountain Cancer Centers, Lone Tree |
| Connecticut | Yale University School of Medicine, New Haven |
| District of Columbia | Sibley Memorial Hospital, Washington D.C. |
| 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 Orlando Health Cancer Institute, Orlando Comprehensive Hematology Oncology, St. Petersburg |
| Georgia | University Cancer & Blood Center, LLC, Athens Emory University School of Medicine- Grady Campus, Atlanta Winship Cancer Institute, Emory University, Atlanta |
| Illinois | University of Chicago Hospital, Chicago University of Illinois at Chicago, Chicago Springfield Clinic Main Campus, Springfield |
| Indiana | Parkview Research Center at Parkview Regional Medical Center, Fort Wayne Community Cancer Center North, Indianapolis Franciscan Health, Indianapolis Indiana University Melvin and Bren Simon Cancer Center, Indianapolis |
| Kansas | The University of Kansas Cancer Center - Westwood, Westwood |
| Kentucky | CHI Saint Joseph Cancer Center - East, Lexington University of Kentucky Chandler Medical Center, Lexington |
| Louisiana | Mary Bird Perkins Cancer Center, Baton Rouge |
| Maryland | Johns Hopkins Bayview Medical Center, Baltimore USO - Maryland Oncology Hematology, Columbia |
| Massachusetts | Boston Medical Center, Boston Lahey Hospital & Medical Center, Burlington |
| Michigan | University of Michigan, Ann Arbor The Cancer & Hematology Centers, Grand Rapids |
| Minnesota | Allina Health Cancer Institute - Abbott Northwestern Hospital, Minneapolis HealthPartners Cancer Research Center, Saint Paul |
| Mississippi | North Mississippi Hematology and Oncology Associates, Tupelo |
| Missouri | Oncology Hematology Associates, Springfield |
| Nevada | Comprehensive Cancer Centers of Nevada, Las Vegas |
| New Hampshire | Dartmouth-Hitchcock Medical Center, Lebanon |
| New Jersey | The Valley Hospital, Inc., Paramus |
| New Mexico | University of New Mexico Comprehensive Cancer Center, Albuquerque |
| New York | Maimonides Cancer Center, Brooklyn Northwell Health/ RJ Zuckerberg Cancer Center, Lake Success Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola Laura and Isaac Perlmutter Cancer Center, New York Manhattan Eye, Ear and Throat Hospital, New York Memorial Sloan Kettering Cancer Center, New York |
| North Carolina | University of North Carolina Medical Center, Chapel Hill Duke Cancer Institute, Durham |
| Ohio | Miami Valley Hospital South, Centerville (Not yet recruiting) USO - Oncology Hematology Care, Cincinnati The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T, Columbus |
| Oregon | USO - Oncology Associates of Oregon, Eugene Asante Rogue Regional Medical Center, Medford Kaiser Permanente Interstate Medical Office Central, Portland Providence Portland Medical Center, Portland Providence St. Vincent Medical Center, Portland |
| Pennsylvania | USO - Alliance Cancer Specialists, PC, Horsham Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office, Philadelphia UPMC Hillman Cancer Center, Pittsburgh |
| Rhode Island | Lifespan Cancer Institute, Providence |
| South Carolina | Medical University of South Carolina, Charleston Prisma Health Cancer Institute, Greenville Lexington Medical Center, West Columbia |
| Tennessee | Tennessee Oncology Chattanooga, Chattanooga University of Tennessee Medical Center, Knoxville Baptist Memorial Hospital-Memphis, Memphis Tennessee Oncology, Nashville USO - US Oncology Research Network, Nashville |
| Texas | USO - Texas Oncology, Austin William Beaumont Army Medical Center, Fort Bliss Houston Methodist Hospital, Houston Lumi Research, Houston University of Texas MD Anderson Cancer Center, Houston USO - Texas Oncology, Webster |
| Vermont | The University of Vermont Medical Center Inc., Burlington |
| Virginia | University of Virginia Health System, Charlottesville USO - Virginia Cancer Specialists, Fairfax VCU Health Adult Outpatient Pavillion, Richmond |
| Washington | Swedish Cancer Institute - Edmonds, Edmonds Kadlec Clinic Hematology and Oncology, Kennewick Swedish Medical Center, Seattle VA Puget Sound Health Care System, Seattle USO - Northwest Cancer Specialists, Vancouver |
| Wisconsin | SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.