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

NCT02546986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-08

Study results available
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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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

CC-486

CC-486 will be administered orally at a dose of 300 mg daily on days 1-14 of each 21-day cycle.

DRUG

Pembrolizumab

Pembrolizumab will be administered as a 30-minute IV infusion on day 1 of each 21-day cycle.

DRUG

Placebo

Placebo will be administered orally daily on days 1-14 of each 21-day cycle.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-09
Primary Completion
2017-04-13
Completion
2025-07-07

Countries

  • United States
  • France
  • Germany
  • Greece
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02546986 on ClinicalTrials.gov