RECRUITING

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

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Conditions

Carcinoma, Non-Small-Cell Lung

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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 main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Official Title

A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02

Quick Facts

Study Start:2025-03-27
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06890598

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. * Histological or cytological confirmation of NSCLC.
  2. * Part A
  3. 1. Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
  4. 2. Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection.
  5. * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
  6. * Must have disease with evidence of KRAS G12C mutation.
  7. * Must have known programmed death-ligand 1 (PD-L1) expression
  8. * Must have an ECOG performance status of 0 or 1.
  9. * Able to swallow oral medication.
  10. * Must have adequate laboratory parameters.
  11. * Contraceptive use should be consistent with local regulations for those participating in clinical studies.
  12. * Women of childbearing potential must
  13. * Have a negative pregnancy test.
  14. * Not be breastfeeding during treatment
  1. * Have known changes in the EGFR or ALK genes.
  2. * Have another type of cancer that is progressing or required active treatment within the past 3 years before screening.
  3. * Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
  4. * Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.

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
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
United States
Highlands Oncology Group
Springdale, Arkansas, 72762
United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
United States
Profound Research LLC
Oceanside, California, 92056
United States
Stanford Cancer Center
Palo Alto, California, 94304
United States
Kaiser Permanente San Diego Mission Road
San Diego, California, 92108
United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
United States
University of Florida - Jacksonville
Jacksonville, Florida, 32209
United States
Florida Cancer Specialists North
Saint Petersburg, Florida, 33705
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Florida Cancer Specialists East
West Palm Beach, Florida, 33401
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Springfield Clinic Main Campus
Springfield, Illinois, 62703
United States
Franciscan Health
Indianapolis, Indiana, 46237
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
CHI Saint Joseph Cancer Center - East
Lexington, Kentucky, 40509
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Reliant Medical Group
Worcester, Massachusetts, 01606
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Missouri Hospital
Columbia, Missouri, 65212
United States
Saint Louis University Cancer Center
Saint Louis, Missouri, 63110
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
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
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
USO - Texas Oncology - San Antonio
San Antonio, Texas, 78240
United States
USO - Texas Oncology Gulf Coast
Sugar Land, Texas, 77479
United States
USO - US Oncology Research Network
The Woodlands, Texas, 77380
United States
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, 23219
United States
Swedish Medical Center
Seattle, Washington, 98104
United States
Northwest Cancer Specialists PC
Vancouver, Washington, 98684
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
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 Date2025-03-27
Study Completion Date2031-12

Study Record Updates

Study Start Date2025-03-27
Study Completion Date2031-12

Terms related to this study

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung