RECRUITING

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

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Conditions

Carcinoma, Non-Small-Cell LungNeoplasm MetastasisAdvanced Non-Small Cell Lung CancerKRAS G12 Lung CancerAdvanced Lung CancerMetastatic Lung CancerKRAS G12C inhibitorKRAS G12C PositiveKRAS MutationKRAS G12 MutationLung Cancer MutationOlomorasibLung DiseasesNeoplastic ProcessesPathologic ProcessesNon-Small Cell Lung CancerNon-Small Cell Lung Cancer (NSCLC)Antineoplastic AgentsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-12-21
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06119581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
  2. * Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
  3. * Must have disease with evidence of KRAS G12C mutation.
  4. * Must have known programmed death-ligand 1 (PD-L1) expression
  5. * Part A: Greater than or equal to (≥)50 percent (%).
  6. * Part B: 0% to 100%.
  7. * Must have measurable disease per RECIST v1.1.
  8. * Must have an ECOG performance status of 0 or 1.
  9. * Estimated life expectancy ≥12 weeks.
  10. * Ability to swallow capsules.
  11. * Must have adequate laboratory parameters.
  12. * Contraceptive use should be consistent with local regulations for those participating in clinical studies.
  13. * Women of childbearing potential must
  14. * Have a negative pregnancy test.
  15. * Not be breastfeeding during treatment
  1. * 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.
  2. * Have had any of the following prior to randomization:
  3. * Have known active central nervous system metastases and/or carcinomatous meningitis.
  4. * Have predominantly squamous cell histology for NSCLC
  5. * 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
  6. * Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
clinical_inquiry_hub@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Clearview Cancer Institute
Huntsville, Alabama, 35805
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
United States
Highlands Oncology Group
Springdale, Arkansas, 72762
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Mercy Cancer Center
Merced, California, 95340
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
United States
BASS Cancer Center
Walnut Creek, California, 94598
United States
USO - Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
United States
Yale University School of Medicine
New Haven, Connecticut, 06510
United States
Sibley Memorial Hospital
Washington, District of Columbia, 20016
United States
Millennium Oncology Research Clinic
Hollywood, Florida, 33024
United States
University of Florida - Jacksonville
Jacksonville, Florida, 32209
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
United States
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, 34474
United States
Comprehensive Hematology Oncology
Saint Petersburg, Florida, 33709
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
University of Chicago Hospital
Chicago, Illinois, 60637
United States
Springfield Clinic Main Campus
Springfield, Illinois, 62702
United States
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
Franciscan Health
Indianapolis, Indiana, 46237
United States
Community Cancer Center North
Indianapolis, Indiana, 46250
United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
United States
CHI Saint Joseph Cancer Center - East
Lexington, Kentucky, 40509
United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
USO - Maryland Oncology Hematology
Annapolis, Maryland, 21401
United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503
United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, 55101
United States
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, 38801
United States
Oncology Hematology Associates
Springfield, Missouri, 65807
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
The Valley Hospital, Inc.
Paramus, New Jersey, 07652
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
United States
Maimonides Cancer Center
Brooklyn, New York, 11220
United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
United States
Manhattan Eye, Ear and Throat Hospital
New York, New York, 10065
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Clinical Research Alliance
Westbury, New York, 11590
United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
United States
Duke Cancer Institute
Durham, North Carolina, 27710
United States
UNC REX Cancer Center
Raleigh, North Carolina, 27607
United States
USO - Oncology Hematology Care
Cincinnati, Ohio, 45242
United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210
United States
USO - Oncology Associates of Oregon
Eugene, Oregon, 97401
United States
Asante Rogue Regional Medical Center
Medford, Oregon, 97504
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225
United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
United States
USO - Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia, Pennsylvania, 19107
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Lifespan Cancer Institute
Providence, Rhode Island, 02903
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
United States
Lexington Medical Center
West Columbia, South Carolina, 29169
United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
USO - US Oncology Research Network
Nashville, Tennessee, 37203
United States
USO - Texas Oncology
Austin, Texas, 78745
United States
William Beaumont Army Medical Center
Fort Bliss, Texas, 79918
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
USO - Texas Oncology
Webster, Texas, 77598
United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05401
United States
University of Virginia Health System
Charlottesville, Virginia, 22903
United States
USO - Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, 23219
United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
United States
Swedish Medical Center
Seattle, Washington, 98104
United States
VA Puget Sound Health Care System
Seattle, Washington, 98108
United States
USO - Northwest Cancer Specialists
Vancouver, Washington, 98684
United States
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21
Study Completion Date2029-10

Study Record Updates

Study Start Date2023-12-21
Study Completion Date2029-10

Terms related to this study

Keywords Provided by Researchers

  • Advanced Non-Small Cell Lung Cancer
  • KRAS G12 Lung Cancer
  • Advanced Lung Cancer
  • Metastatic Lung Cancer
  • KRAS G12C inhibitor
  • KRAS G12C Positive
  • KRAS Mutation
  • KRAS G12 Mutation
  • Lung Cancer Mutation
  • Olomorasib
  • Lung Diseases
  • Neoplastic Processes
  • Pathologic Processes
  • Neoplasm Metastasis
  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Antineoplastic Agents
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Respiratory Tract Diseases
  • Carcinoma, Bronchogenic
  • Bronchial Neoplasms
  • Lung Neoplasms

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis