Study on Pembrolizumab and Vorinostat for Patients with Advanced Stage IV Non-Small Cell Lung Cancer

Inclusion Criteria

• Be willing and able to provide written consent to participate.
• Be 18 years or older.
• Have measurable cancer based on specific medical criteria.
• Provide a sample of tumor tissue if available, or undergo a biopsy if needed.
• Have a specific score indicating the presence of a protein called PD-L1 in the tumor.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function as determined by medical tests.
• Have a confirmed diagnosis of Stage IV non-small cell lung cancer.
• For Phase I: Have cancer that has progressed after at least one prior treatment.
• For Phase II: Be new to treatment for Stage IV cancer, except for those with specific genetic mutations who have had targeted therapy.
• Women of childbearing potential must agree to use two methods of birth control or be surgically sterile during the study and for 120 days after the last dose.
• Men must agree to use barrier contraception during the study and for 120 days after the last dose.

Exclusion Criteria

• Currently participating in another study or have used an investigational drug or device within 4 weeks before starting this study.
• Have a diagnosis of immunodeficiency or are taking high doses of steroids or other immune-suppressing drugs.
• Have a history of tuberculosis.
• Have allergies to pembrolizumab, vorinostat, or their ingredients.
• Have previously been treated with certain immune therapies, unless specified for Phase I.
• Have received recent thoracic radiation or are taking other similar drugs.
• Have had recent chemotherapy or radiation therapy and have not recovered from side effects.
• Have another active cancer that requires treatment, except for certain skin cancers or in situ cervical cancer.
• Have active brain metastases or cancer in the brain lining.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have an active infection needing treatment.
• Are pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after.
• Have a history of HIV or active hepatitis B or C.
• Have received a live vaccine within 30 days before starting the study.
• Have a history of lung inflammation or heart failure.