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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title: A Phase 2 Multicenter, Randomized, Placebo Controlled, Double Blind Study to Assess the Safety and Efficacy of CC-486 (Oral Azacitidine) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Plus Placebo in Subjects With Previously Treated Locally Advanced or Metastatic Non-small Cell Lung Cancer

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This is a Phase 2, multicenter, international, randomized, placebo controlled, double-blind study to assess the safety and efficacy of CC-486 and pembrolizumab combination therapy versus pembrolizumab plus placebo in previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had received one prior platinum-based chemotherapy regimen.

Approximately 100 participants will be randomized 1:1 to receive CC-486 plus pembrolizumab or placebo plus pembrolizumab as follows:

• Arm A: CC-486 300 mg administered orally daily on days 1 to 14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on day 1 of a 21-day cycle

• Arm B: Placebo administered orally daily on days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on day 1 of a 21-day cycle

Randomization will be stratified between treatment arms by histology (non-squamous versus squamous).

The decision to discontinue a patient, which will not be delayed or refused by the Sponsor, remains the responsibility of the treating physician. However, prior to discontinuing a patient, the Investigator may contact the medical monitor and forward appropriate supporting documents for review and discussion.

In the follow-up phase, anticancer treatment administered following the last dose of investigational product (IP) and survival will be followed every 8 weeks until death, withdrawal of consent, or lost-to follow-up, whichever occurs first, or the End of Trial.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

Primary analysis will be conducted when 70 Progression Free Survival (PFS) events have occurred. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

• NCT number: NCT02546986
• Study type: Interventional
• Source: Celgene
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 9, 2015
• Completion date: April 3, 2024