CompletedPhase 2NCT03322540

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

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).

Checked against the public recordLast updated Aug 22, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations101
SponsorIncyte Corporation
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Incyte Corporation
Interventions being studied
Drug: Pembrolizumab; Drug: Epacadostat; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation. * Measurable disease based on RECIST 1.1. * Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥ 50% of tumor cells (tumor proportion score \[TPS\] ≥ 50%) as assessed by immunohistochemistry at a central laboratory. * Life expectancy of at least 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function per protocol-defined criteria. Exclusion Criteria: * Known untreated central nervous system metastases and/or carcinomatous meningitis. * History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. * Symptomatic ascites or pleural effusion. * Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. * Active autoimmune disease that has required systemic treatment in past 2 years. * Has had an allogeneic tissue/solid organ transplant. * Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority. * Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility. * History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. * Use of protocol-defined prior/concomitant therapy.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Pacific Cancer Medical Center, Inc.Anaheim, California
  • Innovative Clinical Research InstituteWhittier, California
  • Florida Cancer Specialists (South Region)Fort Myers, Florida
  • Florida Cancer Specialists (North Region)St. Petersburg, Florida
  • Southeastern Regional Medical Center, Inc.Newnan, Georgia
  • Anne Arundel Health System Research InstituteAnnapolis, Maryland
  • Weinberg Cancer Institute at Franklin SquareBaltimore, Maryland
  • Maryland Oncology Hematology, P.A.Rockville, Maryland
  • UMass Memorial Medical CenterWorcester, Massachusetts
  • Minnesota Oncology Hematology, PACoon Rapids, Minnesota
  • Nebraska Cancer SpecialistsOmaha, Nebraska
  • Allegheny General HospitalPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 22, 2025. Always confirm current availability with the study team.

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