Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC

Summary

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Description

PRIMARY OBJECTIVE: I. To assess the safety and tolerability of combined therapy with atezolizumab and varlilumab in combination with radiation in adult patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on prior PD-1/PD-L1 therapy. SECONDARY OBJECTIVES: I. To determine o...

PRIMARY OBJECTIVE: I. To assess the safety and tolerability of combined therapy with atezolizumab and varlilumab in combination with radiation in adult patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on prior PD-1/PD-L1 therapy. SECONDARY OBJECTIVES: I. To determine objective response rate (excluding the irradiated lesion) of therapy with atezolizumab and varlilumab in combination with radiation. II. To estimate clinical benefit rate of the combination. III. To estimate median progression-free survival of the combination. IV. To compare the frequency of immune-related adverse events (irAEs). OUTLINE: Patients receive varlilumab intravenously (IV) oand atezolizumab IV every 3 weeks or each cycle. Between cycle 1 and 2, patients also receive stereotactic body radiation therapy (SBRT). After completion of study treatment, patients are followed up at 30 days, then every 3 months for up to 1 year.

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