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Clinical trialNCT03322540CompletedPhase 2Interventional

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

SponsorIncyte CorporationEnrollment154Lung Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

101 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Austin Health-Austin Hospital

    Heidelberg, Victoria, Australia

  • St John of God Murdoch Medical Clinic

    Murdoch, Western Australia, Australia

Canada
  • 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

Denmark
  • Rigshospitalet

    Copenhagen, Denmark

  • Regionshospitalet Herning

    Herning, Denmark

  • Odense Universitetshospital

    Odense, Denmark

Estonia
  • Sa Tartu Ulikooli Kliinikum

    Tartu, Estonia

Ireland
  • Galway University Hospital

    Galway, Connacht, Ireland

  • St Vincents University Hospital

    Dublin, Ireland

Israel
  • Soroka Medical Center

    Beersheba, Israel

  • Rambam Medical Center

    Haifa, Israel

  • Meir Medical Center

    Kfar Saba, Israel

  • Rabin Medical Center

    Petah Tikva, Israel

  • Chaim Sheba Medical Center

    Ramat Gan, Israel

Italy
  • Irccs A.O.U. San Martino - Ist

    Genova, Italy

  • Policlinico Universitario Agostino Gemelli

    Roma, Italy

Japan
  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, Japan

  • Sendai Kousei Hospital

    Sendai, Miyagi, Japan

  • Kansai Medical University Hospital

    Hirakata, Osaka, Japan

  • Kindai University Hospital

    Sayama, Osaka, Japan

  • Shizuoka Cancer Center

    Nagaizumi-chō, Shizuoka, Japan

  • Kyushu University Hospital

    Fukuoka, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Japan

  • Niigata Cancer Center Hospital

    Niigata, Japan

  • Okayama University Hospital

    Okayama, Japan

  • National Cancer Center Hospital

    Tokyo, Japan

  • Nippon Medical School Hospital

    Tokyo, Japan

  • the Cancer Institute Hospital of Jfcr

    Tokyo, Japan

  • Wakayama Medical University Hospital

    Wakayama, Japan

Malaysia
  • Institut Kanser Negara - National Cancer Institute

    Putrajaya, Kuala Lumpur, Malaysia

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, Malaysia

  • Pantai Hospital Kuala Lumpur

    Kuala Lumpur, Malaysia

61 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

EpacadostatPembrolizumab →Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Dec 2017
Primary completion
10 Jan 2019
Completion
9 Nov 2020
Last update posted
22 Aug 2025
Registered enrollment
154
Registry id
NCT03322540

Cross-registrations

EU-CTR / CTIS (EudraCT)2017-001841-28

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.