Study on Olomorasib with Standard Treatment for Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Sponsor score: 60
ClinicalTrials ID:NCT06890598
This clinical trial is testing whether the drug olomorasib, when combined with standard treatments, is more effective than standard treatments alone for patients with a specific type of lung cancer that has a KRAS G12C mutation.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find out if adding olomorasib to standard treatments like pembrolizumab or durvalumab can better control non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. It involves patients whose cancer has been surgically removed or cannot be removed. The trial may last up to 3 years for each participant.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC).
- For Part A: Have Stage II-IIIB cancer treated with chemoimmunotherapy before surgery, with some tumor remaining after surgery. Patients with no remaining tumor are not eligible.
- For Part B: Have Stage III cancer that cannot be removed by surgery and has not worsened after chemotherapy and radiation.
- Have a KRAS G12C mutation in the cancer.
- Have known PD-L1 expression.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Be able to swallow pills.
- Have acceptable blood test results.
- Use contraception as per local guidelines if applicable.
- Women of childbearing potential must:
- Have a negative pregnancy test.
- Not breastfeed during treatment.
Exclusion Criteria
- Have known changes in the EGFR or ALK genes.
- Have another type of cancer that is getting worse or needed treatment in the last 3 years.
- Have an active autoimmune disease that needed treatment in the last 2 years, except for hormone replacement therapy.
- Have had severe immune-related side effects from previous immunotherapy, or any unresolved immune-related side effects, except for those on stable hormone replacement therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clearview Cancer Institute | 35805 | Huntsville | Alabama |
| The University of Arizona Cancer Center - North Campus | 85719 | Tucson | Arizona |
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| UCLA Hematology/Oncology - Santa Monica | 90404 | Los Angeles | California |
| Profound Research LLC | 92056 | Oceanside | California |
| Stanford Cancer Center | 94304 | Palo Alto | California |
| Kaiser Permanente San Diego Mission Road | 92108 | San Diego | California |
| BASS Cancer Center | 94598 | Walnut Creek | California |
| Hartford Hospital (HH) | 06102 | Hartford | Connecticut |
| Boca Raton Regional Hospital | 33486 | Boca Raton | Florida |
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