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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer

In brief

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).

Key facts

Study ID

NCT03322540

Run by

Incyte Corporation

People needed

154

Starts

2017-12-15

Expected to finish

2020-11-09

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Innovative Clinical Research Institute — Whittier, California, United States
• Florida Cancer Specialists (South Region) — Fort Myers, Florida, United States
• Florida Cancer Specialists (North Region) — St. Petersburg, Florida, United States
• Southeastern Regional Medical Center, Inc. — Newnan, Georgia, United States
• Anne Arundel Health System Research Institute — Annapolis, Maryland, United States
• Weinberg Cancer Institute at Franklin Square — Baltimore, Maryland, United States
• Maryland Oncology Hematology, P.A. — Rockville, Maryland, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Minnesota Oncology Hematology, PA — Coon Rapids, Minnesota, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Tennessee Oncology, PLLC/The Sarah Cannon Research Institute — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC/The Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Texas Oncology-South Austin — Austin, Texas, United States
• Austin Health-Austin Hospital — Heidelberg, Victoria, Australia
• St John of God Murdoch Medical Clinic — Murdoch, Western Australia, Australia
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Moncton Hospital - Horizon Health Network — Moncton, New Brunswick, Canada
• William Osler Health System — Brampton, Ontario, Canada
• Cancer Centre of Southeastern Ontario at Kingston General Hospital — Kingston, Ontario, Canada
• Sault Area Hospital — Sault Ste. Marie, Ontario, Canada
• Rigshospitalet — Copenhagen, Denmark
• Regionshospitalet Herning — Herning, Denmark
• Odense Universitetshospital — Odense, Denmark
• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.