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Clinical Trials in India / NCT06890598
Recruiting Phase 3

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

NCT06890598 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2025-03-27
Last updated
2026-09-08

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

OlomorasibPembrolizumabDurvalumabPlacebo

Olomorasib: Administered orally.

Pembrolizumab: Administered intravenously (IV).

Durvalumab: Administered IV.

Placebo: Administered orally.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histological or cytological confirmation of NSCLC. * Part A 1. 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. 2. 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.

Primary outcome measure(s)

Trial sites (369)

FacilityCityRegionStatus
Clearview Cancer Institute Huntsville Alabama Recruiting
Infirmary Cancer Care Mobile Alabama Not Yet Recruiting
City of Hope, Phoenix Phoenix Arizona Not Yet Recruiting
The University of Arizona Cancer Center - North Campus Tucson Arizona Recruiting
Highlands Oncology Group Springdale Arkansas Recruiting
UCLA Hematology/Oncology - Santa Monica Los Angeles California Recruiting
Profound Research LLC Oceanside California Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California Recruiting
Stanford Cancer Center Palo Alto California Recruiting
Kaiser Permanente San Diego Mission Road San Diego California Recruiting
BASS Cancer Center Walnut Creek California Recruiting
Hartford Hospital (HH) Hartford Connecticut Recruiting
Sibley Memorial Hospital Washington D.C. District of Columbia Recruiting
Boca Raton Regional Hospital Boca Raton Florida Recruiting
Florida Cancer Specialists - South Fort Myers Florida Recruiting
University of Florida - Jacksonville Jacksonville Florida Recruiting
Miami Cancer Institute at Baptist Health, Inc. Miami Florida Recruiting
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala Ocala Florida Recruiting
Florida Cancer Specialists North St. Petersburg Florida Recruiting
Comprehensive Hematology Oncology St. Petersburg Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Florida Cancer Specialists East West Palm Beach Florida Recruiting
University Cancer & Blood Center, LLC Athens Georgia Not Yet Recruiting
Winship Cancer Institute Atlanta Georgia Recruiting
City of Hope National Medical Center, Atlanta Cancer Center Newnan Georgia Not Yet Recruiting
City of Hope, Chicago Chicago Illinois Not Yet Recruiting
Northwestern Memorial Hospital Chicago Illinois Suspended
University of Illinois at Chicago Chicago Illinois Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Captain James A. Lovell Federal Health Care Center North Chicago Illinois Recruiting
OSF Saint Francis Medical Center Peoria Illinois Not Yet Recruiting
Springfield Clinic Main Campus Springfield Illinois Recruiting
Parkview Research Center at Parkview Regional Medical Center Fort Wayne Indiana Recruiting
Franciscan Health Indianapolis Indiana Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
Baptist Health Hamburg Lexington Kentucky Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Recruiting
Ochsner Health Ochsner Cancer Center - Baton Rouge Baton Rouge Louisiana Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Recruiting
New England Cancer Specialists Westbrook Maine Recruiting

+ 329 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile → 📄 Imfinzi (durvalumab) drug profile →

More Eli Lilly and Company trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06890598 on ClinicalTrials.gov ↗ ← All trials in India