Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy

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PRIMARY OBJECTIVES: I. Determine the recommended phase II dose (RP2D) of temozolomide in combination with niraparib and atezolizumab. (Phase Ib) II. Evaluate the efficacy of niraparib plus temozolomide plus atezolizumab at RP2D (Arm A) compared with atezolizumab (Arm B) as measured by progression-fr...

PRIMARY OBJECTIVES: I. Determine the recommended phase II dose (RP2D) of temozolomide in combination with niraparib and atezolizumab. (Phase Ib) II. Evaluate the efficacy of niraparib plus temozolomide plus atezolizumab at RP2D (Arm A) compared with atezolizumab (Arm B) as measured by progression-free survival (PFS). (Phase II) SECONDARY OBJECTIVES: I. To evaluate the efficacy of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone, as measured by overall survival (OS). II. To evaluate the efficacy of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone, as measured by objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. III. To evaluate the safety of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone as measured by adverse events (AEs). EXPLORATORY OBJECTIVE: I. To assess participant-reported outcomes on health-related quality of life and adverse events. OUTLINE: This is a dose-escalation study of temozolomide. Patients are randomized to 1 of 2 arms. ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5 and niraparib PO QD on days 1-28. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care atezolizumab intravenously (IV) every 3 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 8 weeks for 24 weeks, and then every 12 weeks for up to 1 year.

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