Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03322540
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 154 participants
Conditions and interventions
Conditions
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 15, 2017 (Actual)
- Primary completion
- Jan 10, 2019 (Actual)
- Completion
- Nov 9, 2020 (Actual)
- Last update posted
- Aug 22, 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 22, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03322540 live on ClinicalTrials.gov.