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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

Sponsor: Eli Lilly and Company · Participants: 1,264 · Started: Dec 21, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06119581

Locations in the U.S.

AlabamaClearview Cancer Institute, Huntsville
ArizonaBanner MD Anderson Cancer Center, Gilbert
Banner University Medical Center Phoenix, Phoenix
The University of Arizona Cancer Center - North Campus, Tucson
ArkansasHighlands Oncology Group, Springdale
CaliforniaCedars-Sinai Medical Center, Los Angeles
BASS Cancer Center, Walnut Creek
ColoradoUSO - Rocky Mountain Cancer Centers, Lone Tree
ConnecticutYale University School of Medicine, New Haven
District of ColumbiaSibley Memorial Hospital, Washington D.C.
FloridaMillennium 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
GeorgiaUniversity Cancer & Blood Center, LLC, Athens
Emory University School of Medicine- Grady Campus, Atlanta
Winship Cancer Institute, Emory University, Atlanta
IllinoisUniversity of Chicago Hospital, Chicago
University of Illinois at Chicago, Chicago
Springfield Clinic Main Campus, Springfield
IndianaParkview 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
KansasThe University of Kansas Cancer Center - Westwood, Westwood
KentuckyCHI Saint Joseph Cancer Center - East, Lexington
University of Kentucky Chandler Medical Center, Lexington
LouisianaMary Bird Perkins Cancer Center, Baton Rouge
MarylandJohns Hopkins Bayview Medical Center, Baltimore
USO - Maryland Oncology Hematology, Columbia
MassachusettsBoston Medical Center, Boston
Lahey Hospital & Medical Center, Burlington
MichiganUniversity of Michigan, Ann Arbor
The Cancer & Hematology Centers, Grand Rapids
MinnesotaAllina Health Cancer Institute - Abbott Northwestern Hospital, Minneapolis
HealthPartners Cancer Research Center, Saint Paul
MississippiNorth Mississippi Hematology and Oncology Associates, Tupelo
MissouriOncology Hematology Associates, Springfield
NevadaComprehensive Cancer Centers of Nevada, Las Vegas
New HampshireDartmouth-Hitchcock Medical Center, Lebanon
New JerseyThe Valley Hospital, Inc., Paramus
New MexicoUniversity of New Mexico Comprehensive Cancer Center, Albuquerque
New YorkMaimonides 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 CarolinaUniversity of North Carolina Medical Center, Chapel Hill
Duke Cancer Institute, Durham
OhioMiami 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
OregonUSO - 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
PennsylvaniaUSO - Alliance Cancer Specialists, PC, Horsham
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office, Philadelphia
UPMC Hillman Cancer Center, Pittsburgh
Rhode IslandLifespan Cancer Institute, Providence
South CarolinaMedical University of South Carolina, Charleston
Prisma Health Cancer Institute, Greenville
Lexington Medical Center, West Columbia
TennesseeTennessee Oncology Chattanooga, Chattanooga
University of Tennessee Medical Center, Knoxville
Baptist Memorial Hospital-Memphis, Memphis
Tennessee Oncology, Nashville
USO - US Oncology Research Network, Nashville
TexasUSO - 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
VermontThe University of Vermont Medical Center Inc., Burlington
VirginiaUniversity of Virginia Health System, Charlottesville
USO - Virginia Cancer Specialists, Fairfax
VCU Health Adult Outpatient Pavillion, Richmond
WashingtonSwedish 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
WisconsinSSM 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.