Study Comparing Niraparib and Pembrolizumab with Placebo and Pembrolizumab for Maintenance Therapy in Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) without specific genetic changes that can be targeted by other treatments.
• Have advanced or metastatic NSCLC that cannot be treated with chemoradiotherapy.
• Completed 4 to 6 cycles of initial chemotherapy with pembrolizumab.
• Cancer must have stabilized or improved after initial treatment.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Have a life expectancy of at least 12 weeks.
• Have adequate organ and bone marrow function.
• Must provide tumor samples for the study.
• Be able to swallow pills.
• Women must not be pregnant or breastfeeding and must use contraception during treatment and for 180 days after.
• Men must agree to use contraception and not donate sperm during treatment and for 90 days after.
• Must understand and agree to participate in the study by signing a consent form.

Exclusion Criteria

• Have mixed small cell lung cancer or a specific variant of NSCLC.
• Have used PARP inhibitors in previous treatments.
• Have high blood pressure above specified levels.
• Have significant digestive issues affecting medication absorption.
• Have certain brain or spinal cord conditions.
• Have used certain growth factors within 4 weeks before starting the study.
• Have active or past autoimmune or inflammatory disorders.
• Are on high doses of systemic steroids.
• Have another active cancer needing treatment.
• Are pregnant, breastfeeding, or planning to conceive during or shortly after the study.
• Have a history of specific blood disorders or leukemia.
• Have a history of active tuberculosis.
• Have current or recent lung inflammation or related conditions.