Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer

PRIMARY OBJECTIVE: I. To determine the safety and tolerability of the combination of vismodegib and atezolizumab in patients with advanced NSCLC based upon the Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria. SECONDARY OBJECTIVE: I. To determine the efficacy of the combination of vismodegib and atezolizumab in patients with advanced NSCLC, including progression-free survival (PFS), objective response (ORR), disease control rate (DCR), and overall survival (OS) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. EXPLORATORY OBJECTIVE: I. To study the effect of vismodegib on the levels of M2-TAMs and CD8+ T cells within the tumor microenvironment (TME) as well as myeloid-derived suppressor cells (MDSCs) in peripheral blood of study patients. OUTLINE: Patients receive vismodegib orally (PO) daily on days 1-28 and atezolizumab intravenously (IV) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Some patients undergo tissue sample collection during screening and on study. After completion of study treatment, patients are followed up every 12 weeks.