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

NCT03322540 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-08-22

Study results available
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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

Interventions

DRUG

Pembrolizumab

Pembrolizumab administered intravenously every 3 weeks.

DRUG

Epacadostat

Epacadostat administered orally twice daily.

DRUG

Placebo

Matching placebo administered orally twice daily.

Sponsors & Collaborators

Principal Investigators

  • Lance Leopold, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2019-01-10
Completion
2020-11-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Estonia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Poland
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03322540 on ClinicalTrials.gov