NCT03322540

Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)

A Phase 2, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab administered intravenously every 3 weeks.
DRUG	Epacadostat	Epacadostat administered orally twice daily.
DRUG	Placebo	Matching placebo administered orally twice daily.

Timeline

• Start date: 2017-12-15
• Primary completion: 2019-01-10
• Completion: 2020-11-09
• First posted: 2017-10-26
• Last updated: 2025-08-22
• Results posted: 2020-02-05

Locations

101 sites across 18 countries: United States, Australia, Canada, Denmark, Estonia, Ireland, Israel, Italy, Japan, Malaysia, Poland, Russia, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study