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

Purpose

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.

Condition

  • Carcinoma, Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histological or cytological confirmation of NSCLC. - Part A 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. 2. Pathologic Stage II-IIIB (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 changes in the EGFR or ALK genes. - Have another type of cancer that is progressing or required active treatment within the past 3 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Both Part A and B are randomized, double-blind, placebo-controlled.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: Olomorasib + Pembrolizumab 		Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
  • Drug: Olomorasib
    Administered orally.
    Other names:
    • LY3537982
  • Drug: Pembrolizumab
    Administered intravenously (IV).
Placebo Comparator
Part A: Placebo + Pembrolizumab 		Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
  • Drug: Pembrolizumab
    Administered intravenously (IV).
  • Drug: Placebo
    Administered orally.
Experimental
Part B: Olomorasib + Durvalumab 		Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
  • Drug: Olomorasib
    Administered orally.
    Other names:
    • LY3537982
  • Drug: Durvalumab
    Administered IV.
Placebo Comparator
Part B: Placebo + Durvalumab 		Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
  • Drug: Durvalumab
    Administered IV.
  • Drug: Placebo
    Administered orally.

Recruiting Locations

Highlands Oncology Group
Springdale, Arkansas 72762
Contact:
479-872-8130

Profound Research LLC
Oceanside, California 92056

University of Florida - Jacksonville
Jacksonville, Florida 32209

Springfield Clinic Main Campus
Springfield, Illinois 62703

Franciscan Health
Indianapolis, Indiana 46237
Contact:
317-528-5173

CHI Saint Joseph Cancer Center - East
Lexington, Kentucky 40509

Reliant Medical Group
Worcester, Massachusetts 01606
Contact:
508-556-5400

More Details

NCT ID
NCT06890598
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center