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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.