Study on Targeting ODC as an Immunotherapy for Advanced Non-Small Cell Lung Cancer with STK11 Mutation

Inclusion Criteria

• Be willing and able to provide written consent to participate.
• Be 18 years or older.
• Have cancer that can be measured by scans.
• Provide a sample of the tumor tissue, if available.
• For Phase I: Undergo a fresh biopsy if no previous tissue is available.
• For Phase II: Provide a new biopsy sample from a tumor.
• Have a tumor with a PD-L1 score of 1% or higher.
• Be in good overall health with a performance status of 0 or 1.
• Have normal organ function based on lab tests.
• Have Stage IV NSCLC with an STK11 mutation.
• For Phase I: Have had at least one previous treatment.
• For Phase II: Have not had treatment for Stage IV NSCLC, except for specific targeted therapies.
• Women of childbearing potential must have a negative pregnancy test and agree to use two forms of birth control.
• Men must agree to use barrier contraception.
• Must not have significant hearing loss requiring a hearing aid.

Exclusion Criteria

• Currently participating in another study or have used an investigational drug or device recently.
• Have an immune system deficiency or are on high-dose steroids or other immune-suppressing drugs.
• Have a history of tuberculosis.
• Are allergic to pembrolizumab, DFMO, or their ingredients.
• For Phase II: Have had previous treatment with certain immune therapies.
• Have had recent high-dose chest radiation.
• Have had a recent monoclonal antibody treatment and not fully recovered from side effects.
• Have had major surgery recently and not fully recovered.
• Have another active cancer needing treatment, except for certain skin or cervical cancers.
• Have active brain cancer or cancer in the brain's lining.
• Have an active autoimmune disease needing treatment in the past two years.
• Have an active infection needing treatment.
• Have a condition or history that could interfere with the study or increase risk.
• Have a psychiatric or substance abuse disorder affecting participation.
• Have HIV or active Hepatitis B or C.
• Have had a live vaccine recently.
• Have a history of lung inflammation needing steroids.
• Have interstitial lung disease.
• Have a history of significant heart failure.
• Have STK11 variants considered benign.