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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
Sponsor: Eli Lilly and Company
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1264
Start Date
2023-12-21
Completion Date
2031-01
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
LY3537982
Administered orally.
Pembrolizumab
Administered IV.
Placebo
Administered orally.
Cisplatin
Administered IV.
Carboplatin
Administered IV.
Pemetrexed
Administered IV.
Locations (416)
Clearview Cancer Institute
Huntsville, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
BASS Cancer Center
Walnut Creek, California, United States
USO - Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Millennium Oncology Research Clinic
Hollywood, Florida, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Hospital
Chicago, Illinois, United States
Springfield Clinic Main Campus
Springfield, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Franciscan Health
Indianapolis, Indiana, United States
Community Cancer Center North
Indianapolis, Indiana, United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
USO - Maryland Oncology Hematology
Columbia, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Valley Hospital, Inc.
Paramus, New Jersey, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Manhattan Eye, Ear and Throat Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Duke Cancer Institute
Durham, North Carolina, United States
Miami Valley Hospital South
Centerville, Ohio, United States
USO - Oncology Hematology Care
Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, United States
USO - Oncology Associates of Oregon
Eugene, Oregon, United States
Asante Rogue Regional Medical Center
Medford, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, United States
USO - Alliance Cancer Specialists, PC
Horsham, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
USO - US Oncology Research Network
Nashville, Tennessee, United States
USO - Texas Oncology
Austin, Texas, United States
William Beaumont Army Medical Center
Fort Bliss, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Lumi Research
Houston, Texas, United States
USO - Texas Oncology
Webster, Texas, United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
USO - Virginia Cancer Specialists
Fairfax, Virginia, United States
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
USO - Northwest Cancer Specialists
Vancouver, Washington, United States
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical
Madison, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, Australia
Icon Cancer Centre Wesley
Auchenflower, Australia
Ballarat Health Services
Ballarat Central, Australia
Sunshine Coast University Hospital
Birtinya, Australia
Gosford Hospital
Gosford, Australia
Mackay Base Hospital
Mackay, Australia
St Vincent's Hospital
Melbourne, Australia
Sir Charles Gairdner Hospital
Perth, Australia
Goulburn Valley Health
Shepparton, Australia
Gold Coast University Hospital
Southport, Australia
The Townsville Hospital
Townsville, Australia
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria