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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03322540

Public ClinicalTrials.gov record NCT03322540. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT03322540
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Incyte Corporation
Industry
Enrollment
154 participants

Conditions and interventions

Conditions

Interventions

  • Epacadostat Drug
  • Pembrolizumab Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 14, 2017
Primary completion
Jan 9, 2019
Completion
Nov 8, 2020
Last update posted
Aug 21, 2025

2017 – 2020

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Pacific Cancer Medical Center, Inc. Anaheim California 92801
Innovative Clinical Research Institute Whittier California 90603
Florida Cancer Specialists (South Region) Fort Myers Florida 33916
Florida Cancer Specialists (North Region) St. Petersburg Florida 33705
Southeastern Regional Medical Center, Inc. Newnan Georgia 30265
Anne Arundel Health System Research Institute Annapolis Maryland 21401
Weinberg Cancer Institute at Franklin Square Baltimore Maryland 21237
Maryland Oncology Hematology, P.A. Rockville Maryland 20850
UMass Memorial Medical Center Worcester Massachusetts 01655
Minnesota Oncology Hematology, PA Coon Rapids Minnesota 55433
Nebraska Cancer Specialists Omaha Nebraska 68130
Allegheny General Hospital Pittsburgh Pennsylvania 15224
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute Chattanooga Tennessee 37404
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute Nashville Tennessee 37203
Texas Oncology-South Austin Austin Texas 78745

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03322540, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 21, 2025 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03322540 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →