Combining Olomorasib with Standard Treatments for KRAS G12C-mutant Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of olomorasib when combined with pembrolizumab in patients with resected KRAS G12C-mutant non-small cell lung cancer (NSCLC) and with durvalumab in those with unresectable KRAS G12C-mutant NSCLC. Participants will be assigned to one of two parts based on their cancer stage and treatment history. The study aims to determine if these combinations provide better outcomes compared to standard treatments with placebo. Each participant may be involved in the study for up to three years.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clearview Cancer Institute
  Huntsville, Alabama, United States Recruiting
• The University of Arizona Cancer Center - North Campus
  Tucson, Arizona, United States Recruiting
• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• UCLA Hematology/Oncology - Santa Monica
  Los Angeles, California, United States Recruiting
• Profound Research LLC
  Oceanside, California, United States Recruiting
• University of California, Irvine (UCI) Health - UC Irvine Medical Center
  Orange, California, United States Recruiting

+318 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.