Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer

Summary

The purpose of this study is to determine whether the combination therapy of CC-486 (oral azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab alone in patients with previously treated locally advanced or metastatic non-small cell lung cancer.

Timeline

Start

2015-10-09

Primary completion

2017-04-13

Completion

2025-07-07

Outcome

Missed primary endpoint

registry analysis (superiority test); CC-486 and Pembrolizumab (CC-486 + PBZ) vs Placebo and Pembrolizumab (PBO + PBZ); p = 0.1789 NCT02546986 ↗

registry analysis (superiority test); CC-486 and Pembrolizumab (CC-486 + PBZ) vs Placebo and Pembrolizumab (PBO + PBZ); p = 0.1990 NCT02546986 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CC-486	Unknown	300 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications