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
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.
Detailed description
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.
Arms & interventions
- DrugLY3537982
Administered orally.
- DrugPembrolizumab
Administered IV.
- DrugPlacebo
Administered orally.
- DrugCisplatin
Administered IV.
- DrugCarboplatin
Administered IV.
- DrugPemetrexed
Administered IV.
Outcome measures
Primary
Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: Progression-Free Survival (PFS)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Secondary
Part A and Part B: Overall Survival (OS)
Time frame: Randomization to date of death from any cause. (Estimated as up to 3 years)
Part A and Part B: PFS
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Time frame: Randomization to disease progression or death. (Estimated as approximately 1 year)
Part A and Part B: Duration of Response (DOR)
Time frame: Date of first evidence of CR or PR to date of disease progression or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)
Time frame: Randomization to disease progression or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: Time to Response (TTR)
Time frame: Time from randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 1 year)
Part A and Part B: Intracranial Overall Response Rate (ORR)
Time frame: Randomization to intracranial disease progression or death. (Estimated as approximately 1 year)
Part A and Part B: Intracranial Duration of Response (DoR)
Time frame: Date of first evidence of CR or PR to date of intracranial disease progression or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: PFS2
Time frame: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 1 year
Part A and Part B: Changes in NSCLC-related symptoms as measured by NSCLC-SAQ
Time frame: Randomization through end of treatment (Estimated as approximately 1 year)]
Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ)
Time frame: Randomization through end of treatment (Estimated as approximately 1 year)
Part A and Part B: Changes in physical function, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning subscale and IL19
Time frame: Randomization through end of treatment (Estimated as approximately 1 year)
Part A and Part B: Time to Deterioration in Physical Function, as Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning Subscale and IL19
Time frame: Randomization through end of treatment (Estimated as approximately 1 year)
Part A and Part B: Proportion of Time with High Side-Effect Burden, as Measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT-GP5)
Time frame: Randomization through end of treatment (Estimated as approximately 1 year)
Part A and Part B: Change from Baseline in Overall Health-related Quality of Life, as Measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale
Time frame: Randomization through end of treatment (Estimated as approximately 1 year)
Eligibility criteria
Study locations (90)
Clearview Cancer Institute
Huntsville, Alabama, 35805
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
Highlands Oncology Group
Springdale, Arkansas, 72762
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mercy Cancer Center
Merced, California, 95340
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
BASS Cancer Center
Walnut Creek, California, 94598
USO - Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
Yale University School of Medicine
New Haven, Connecticut, 06510
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Millennium Oncology Research Clinic
Hollywood, Florida, 33024
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, 34474
Orlando Health Cancer Institute
Orlando, Florida, 32806
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, 30303
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Hospital
Chicago, Illinois, 60637
Springfield Clinic Main Campus
Springfield, Illinois, 62702
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Franciscan Health
Indianapolis, Indiana, 46237
Community Cancer Center North
Indianapolis, Indiana, 46250
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
CHI Saint Joseph Cancer Center - East
Lexington, Kentucky, 40509
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
USO - Maryland Oncology Hematology
Columbia, Maryland, 21044
Boston Medical Center
Boston, Massachusetts, 02118
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
University of Michigan
Ann Arbor, Michigan, 48109
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
HealthPartners Cancer Research Center
Saint Paul, Minnesota, 55101
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, 38801
Oncology Hematology Associates
Springfield, Missouri, 65807
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
The Valley Hospital, Inc.
Paramus, New Jersey, 07652
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
Maimonides Cancer Center
Brooklyn, New York, 11220
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Manhattan Eye, Ear and Throat Hospital
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
Duke Cancer Institute
Durham, North Carolina, 27710
Miami Valley Hospital South
Centerville, Ohio, 45459
USO - Oncology Hematology Care
Cincinnati, Ohio, 45242
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210
USO - Oncology Associates of Oregon
Eugene, Oregon, 97401
Asante Rogue Regional Medical Center
Medford, Oregon, 97504
Providence Portland Medical Center
Portland, Oregon, 97213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
USO - Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia, Pennsylvania, 19107
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Lifespan Cancer Institute
Providence, Rhode Island, 02903
Medical University of South Carolina
Charleston, South Carolina, 29425
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
Lexington Medical Center
West Columbia, South Carolina, 29169
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120
Tennessee Oncology
Nashville, Tennessee, 37203
USO - US Oncology Research Network
Nashville, Tennessee, 37203
USO - Texas Oncology
Austin, Texas, 78745
William Beaumont Army Medical Center
Fort Bliss, Texas, 79918
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Lumi Research
Houston, Texas, 77090
USO - Texas Oncology
Webster, Texas, 77598
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05401
University of Virginia Health System
Charlottesville, Virginia, 22903
USO - Virginia Cancer Specialists
Fairfax, Virginia, 22031
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, 23219
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Swedish Medical Center
Seattle, Washington, 98104
VA Puget Sound Health Care System
Seattle, Washington, 98108
USO - Northwest Cancer Specialists
Vancouver, Washington, 98684
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical
Madison, Wisconsin, 53715
References
- Peters S, Hochmair M, Arbour KC, Rodriguez LP, Reck M, Leal T, R Lindsay C, Shun L, William WN, Spira AI, Sabari JK, Henning Gronberg B, Nishio M, Burns TF, Girard N, Capuzzo F, Merced A, Fasnacht N, Visseren-Grul C, Negrao MV. SUNRAY-01 trial protocol: an innovative study design of olomorasib and pembrolizumab with or without chemotherapy in KRAS G12C NSCLC. Future Oncol. 2026 Apr;22(9):1073-1082. doi: 10.1080/14796694.2026.2651961. Epub 2026 Apr 6.(PubMed)