Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Recruiting · NCT06890598 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histological or cytological confirmation of NSCLC.
- Part A
- Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
- Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.
- Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
- Must have disease with evidence of KRAS G12C mutation.
- Must have known programmed death-ligand 1 (PD-L1) expression
- Must have an ECOG performance status of 0 or 1.
- Able to swallow oral medication.
- 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 known, actionable changes in the EGFR or ALK genes.
- Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
- Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
- 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.
Where it is running
60 locations listed across 32 US states.
- Clearview Cancer Institute - Huntsville, Alabama, United States
- Infirmary Cancer Care - Mobile, Alabama, United States
- City of Hope, Phoenix - Phoenix, Arizona, United States
- The University of Arizona Cancer Center - North Campus - Tucson, Arizona, United States
- Highlands Oncology Group - Springdale, Arkansas, United States
- UCLA Hematology/Oncology - Santa Monica - Los Angeles, California, United States
- Profound Research LLC - Oceanside, California, United States
- University of California, Irvine (UCI) Health - UC Irvine Medical Center - Orange, California, United States
- Stanford Cancer Center - Palo Alto, California, United States
- Kaiser Permanente San Diego Mission Road - San Diego, California, United States
- BASS Cancer Center - Walnut Creek, California, United States
- Hartford Hospital (HH) - Hartford, Connecticut, United States
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States
- Boca Raton Regional Hospital - Boca Raton, Florida, United States
- Florida Cancer Specialists - South - Fort Myers, Florida, United States
- University of Florida - Jacksonville - Jacksonville, 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
- Florida Cancer Specialists North - St. Petersburg, Florida, United States
- Comprehensive Hematology Oncology - St. Petersburg, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Florida Cancer Specialists East - West Palm Beach, Florida, United States
- Winship Cancer Institute - Atlanta, Georgia, United States
- City of Hope National Medical Center, Atlanta Cancer Center - Newnan, Georgia, United States
- City of Hope, Chicago - Chicago, Illinois, United States
- Northwestern Memorial Hospital - Chicago, Illinois, United States
- University of Illinois at Chicago - Chicago, Illinois, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- Captain James A. Lovell Federal Health Care Center - North Chicago, Illinois, United States
- OSF Saint Francis Medical Center - Peoria, Illinois, United States
- Springfield Clinic Main Campus - Springfield, Illinois, United States
- Parkview Research Center at Parkview Regional Medical Center - Fort Wayne, Indiana, United States
- Franciscan Health - Indianapolis, Indiana, United States
- Baptist Health Lexington - Lexington, Kentucky, United States
- Baptist Health Hamburg - Lexington, Kentucky, United States
- CHI Saint Joseph Cancer Center - East - Lexington, Kentucky, United States
- Mary Bird Perkins Cancer Center - Baton Rouge, Louisiana, United States
- Ochsner Health Ochsner Cancer Center - Baton Rouge - Baton Rouge, Louisiana, United States
- Ochsner Clinic Foundation - New Orleans, Louisiana, United States
- New England Cancer Specialists - Westbrook, Maine, United States
- University of Maryland - Baltimore, Maryland, United States
- Johns Hopkins Bayview Medical Center - Baltimore, Maryland, United States
- James M Stockman Cancer Institute - Frederick, Maryland, United States
- Lahey Hospital & Medical Center - Burlington, Massachusetts, United States
- Reliant Medical Group - Worcester, Massachusetts, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States
- Missouri Baptist Medical Center - St Louis, Missouri, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Jefferson Health - Cherry Hill - Cherry Hill, New Jersey, United States
- Sidney Kimmel Cancer Center - Washington Township - Sewell, New Jersey, United States
- Columbia University Irving Medical Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Northport VA Medical Center - Northport, New York, United States
- WakeMed Raleigh Campus - Raleigh, North Carolina, United States
- Aultman Hospital - Canton, Ohio, United States
- Miami Valley Hospital South - Centerville, Ohio, United States
- Fairview Hospital - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T - Columbus, Ohio, United States
- OhioHealth Riverside Methodist Hospital - Columbus, Ohio, United States
Showing 60 of 369 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →