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

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06890598
Protocol IDs
18763 (primary)
NCI-2025-04391
2024-512302-25-00
J3M-MC-JZQH
Study Sponsor
Eli Lilly and Company

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

  1. Histological or cytological confirmation of NSCLC.
  2. Part A
  3. 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.
  4. Pathologic Stage II-IIIB (N0, N1, 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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.