Last updated on November 2019

Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients

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Brief description of study

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab versus placebo following SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

Detailed Study Description

Patients who complete definitive treatment with SoC SBRT and are confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab or placebo.

The primary objective of this study is to assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS. Key secondary is to assess the efficacy of Durvalumab monotherapy compared to placebo in terms of OS.