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
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
- Carcinoma, Non-Small-Cell Lung
- Neoplasm Metastasis
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment target
- 1,264
- Started
- 21 December 2023
- Main results due
- November 2027
- Study sites
- 418
- Registry updated
- 8 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(418)
Clearview Cancer Institute
Huntsville, Alabama, United States
Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Recruiting
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Recruiting
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
Recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Completed
BASS Cancer Center
Walnut Creek, California, United States
Recruiting
USO - Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Recruiting
Yale University School of Medicine
New Haven, Connecticut, United States
Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Recruiting
Millennium Oncology Research Clinic
Hollywood, Florida, United States
Recruiting
University of Florida - Jacksonville
Jacksonville, Florida, United States
Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Recruiting
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, United States
Recruiting
Orlando Health Cancer Institute
Orlando, Florida, United States
Recruiting
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
Recruiting
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Recruiting
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, United States
Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Recruiting
University of Illinois at Chicago
Chicago, Illinois, United States
Recruiting
University of Chicago Hospital
Chicago, Illinois, United States
Recruiting
Springfield Clinic Main Campus
Springfield, Illinois, United States
Recruiting
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Recruiting
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Recruiting
Franciscan Health
Indianapolis, Indiana, United States
Recruiting
Community Cancer Center North
Indianapolis, Indiana, United States
Recruiting
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Recruiting
CHI Saint Joseph Cancer Center - East
Lexington, Kentucky, United States
Recruiting
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Recruiting
USO - Maryland Oncology Hematology
Columbia, Maryland, United States
Recruiting
Boston Medical Center
Boston, Massachusetts, United States
Recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Recruiting
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Recruiting
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States
Recruiting
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, United States
Recruiting
Oncology Hematology Associates
Springfield, Missouri, United States
Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Recruiting
The Valley Hospital, Inc.
Paramus, New Jersey, United States
Recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Recruiting
Maimonides Cancer Center
Brooklyn, New York, United States
Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Recruiting
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Recruiting
Manhattan Eye, Ear and Throat Hospital
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Recruiting
Duke Cancer Institute
Durham, North Carolina, United States
Recruiting
Miami Valley Hospital South
Centerville, Ohio, United States
Not yet recruiting
USO - Oncology Hematology Care
Cincinnati, Ohio, United States
Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, United States
Recruiting
USO - Oncology Associates of Oregon
Eugene, Oregon, United States
Recruiting
Asante Rogue Regional Medical Center
Medford, Oregon, United States
Recruiting
Providence Portland Medical Center
Portland, Oregon, United States
Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, United States
Recruiting
Showing 60 of 418 sites — filter to narrow it down. 414 of the 418 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06119581. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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