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AzTrials

Lung CancerPhase 2NCT03322566

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

A Phase 2 study testing Pembrolizumab, Epacadostat and Platinum-based chemotherapy in people with Lung Cancer, run by Incyte Corporation at 94 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Pembrolizumab, Epacadostat and Platinum-based chemotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
233 participants
Where
94 sitesin 14 countries
Study dates
9 Jan 2018to 16 Oct 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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.
  • Provide tumor tissue sample.

Who cannot join

  • Known untreated central nervous system metastases and/or carcinomatous meningitis
  • History of (non-infectious) 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

94 sites in 14 countries.

94 sites in 14 countries

United States21 sites

  • New York Oncology Hematology P.C

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • St. Vincent Healthcare Frontier Cancer Center

    Billings, Montana, 59102

  • Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060

  • Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22908

  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Southern Cancer Center, PC

    Daphne, Alabama, 36526

  • Texas Oncology-Denton South

    Denton, Texas, 76210

  • St. Luke's Hospital - Anderson Campus

    Easton, Pennsylvania, 18045

  • Florida Cancer Specialists (South Region)

    Fort Myers, Florida, 33901-8101

  • PPG-Oncology

    Fort Wayne, Indiana, 46845

  • Western Regional Medical Center, Inc.

    Goodyear, Arizona, 85338

  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15224

  • MMCORC

    Saint Louis Park, Minnesota, 55416

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Florida Cancer Specialists (North Region)

    St. Petersburg, Florida, 33705

  • Arizona Oncology Associates PC- HOPE

    Tucson, Arizona, 85704

  • Southwestern Regional Medical Center, Inc.

    Tulsa, Oklahoma, 74133

Other trials in United States

Russia10 sites

  • Belgorod Regional Oncology Dispensary

    Belgorod, 308010

  • Udmurtia Republic Regional Clinical Oncology Dispensary

    Izhevsk, 426067

  • Republican Clinical Oncology Dispensary of Tatarstan MoH

    Kazan', 420029

  • Central Clinical Hospital with polyclinic

    Moscow, 121359

  • Moscow Research Oncology Institute

    Moscow, 125284

  • SBI of Stavropol region Pyatigorskiy Oncologic dispensary

    Pyatigorsk, 357502

  • SBHI Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • SBHI Samara Regional Clinical Oncology Dispensary

    Samara, 443031

  • Oncological Dispensary #2 of Ministry of Health of Krasnodar region

    Sochi, 354057

  • Tomsk Scientific Research Institute of Oncology

    Tomsk, 634028

Other trials in Russia

Turkey (Türkiye)9 sites

  • Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi

    Adana, 01120

  • Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi

    Adana, 01330

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100

  • Uludag Universitesi Tip Fakultesi

    Bursa, 16059

  • Pamukkale Unv. Tip Fak

    Denizli, 20070

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, Bornova, 35100

  • Samsun Medical Park Hastanesi

    Samsun, 55200

  • Namık Kemal University Medical Faculty

    Tekirdağ, 59030

Other trials in Turkey (Türkiye)

Canada8 sites

  • CISSS de la Monteregie-Centre

    Greenfield Park, Quebec, J4V 2H1

  • BCCA-Cancer Centre of the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • CSSS de Laval- Hopital de la Cite de la Sante

    Laval, Quebec, H7M 3L9

  • CIUSSS Ouest de l'Ile - St-Mary's Hospital

    Montreal, Quebec, H3T 1M5

  • CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Lions Gate Hospital

    North Vancouver, British Columbia, V7L 2L7

  • CHU de Quebec - Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • CIUSSS de la Mauricie-et-du-Centre-du-Quebec

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Australia6 sites

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Cairns Base Hospital

    Cairns, Queensland, 4870

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

  • MNCCI Port Macquarie Base Hospital

    Port Macquarie, New South Wales (Australia), 2444

  • The Crown Princess Mary Cancer Centre Westmead

    Westmead, New South Wales, 2145

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

Hungary6 sites

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 1121

  • Veszprem Megyei Tudogyogyintezet

    Farkasgyepű, 8582

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, 5700

  • CRU Hungary Kft.

    Miskolc, 3529

  • Zala Megyei Korhaz Pozvai Telephely

    Pózva, Zalaegerszeg, 8900

  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

    Szolnok, 5004

Other trials in Hungary

Israel6 sites

  • Ha Emek Medical Center

    Afula, 1834111

  • Soroka Medical Center

    Beersheba, 8457108

  • Rambam Medical Center

    Haifa, 3525408

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 5262000

  • Chaim Sheba Medcal Center

    Ramat Gan, 52621

Other trials in Israel

Spain6 sites

  • Hospital Juan Ramón Jimenez

    Huelva, 21005

  • Institut Catala Oncologia de Bellvitge - ICO

    L'Hospitalet de Llobregat, 08980

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, Gran Canaria, 35016

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario La Fe

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Italy5 sites

  • Centro Di Riferimento Oncologico

    Aviano, 33081

  • A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico

    Catania, 95123

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Ospedale San Gerardo - ASST Monza

    Monza, 20900

Other trials in Italy

Taiwan5 sites

  • Chang Gung Medical Foundation, Kaohsiung Branch

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70457

  • National Taiwan University Hospital

    Taipei, 10048

  • Chang Gung Medical Foundation, Linkou Branch

    Taoyuan, 33305

Other trials in Taiwan

South Korea4 sites

  • National Cancer Center

    Goyang-si, 10408

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

United Kingdom4 sites

  • Western General Hospital

    Edinburgh, EH42XU

  • North Middlesex Hospital

    London, N18 1QX

  • Freeman Hospital Newcastle upon Tyne Foundation NHS Trust

    Newcastle upon Tyne, NE7 7DN

  • Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN

Other trials in United Kingdom

Mexico3 sites

  • Medical Care Research S.A. de C.V.

    Mérida, Yucatán, 97070

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000

  • FAICIC Clinical Research

    Veracruz, 91900

Other trials in Mexico

Ireland1 site

  • St Vincents University Hospital

    Dublin, Dublin 4

Other trials in Ireland

About this study

Official title: A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).

Conditions
Lung Cancer
Being tested
Pembrolizumab, Epacadostat, Platinum-based chemotherapy, Placebo
Keywords
Non-small cell lung cancer, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor, chemotherapy
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called MK-3475

    Pembrolizumab administered intravenously every 3 weeks.

  • EpacadostatDrug

    Also called INCB024360

    Epacadostat administered orally twice daily.

  • Platinum-based chemotherapyDrug

    Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.

  • PlaceboDrug

    Matching placebo administered orally twice daily.

Study groups in NCT03322566
Study groupRoleWhat they receive
Pembrolizumab + Chemotherapy + EpacadostatExperimentalParticipant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Receives: Drug: Pembrolizumab; Drug: Epacadostat; Drug: Platinum-based chemotherapy
Pembrolizumab + Chemotherapy + PlaceboExperimentalParticipant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Receives: Drug: Pembrolizumab; Drug: Platinum-based chemotherapy; Drug: Placebo
Pembrolizumab + EpacadostatExperimentalParticipant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
Receives: Drug: Pembrolizumab; Drug: Epacadostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).

    Measured: Assessed every 12 weeks up to 24 months

Secondary outcomes (5)

  1. Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to 24 months

  2. Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    Defined as the time from randomization to death due to any cause.

    Measured: Up to 24 months

  3. Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.

    Measured: Up to 24 months

  4. Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: Up to 25 months

  5. Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs

    An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.

    Measured: Up to 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2017
  2. Study start9 Jan 2018
  3. Primary completion13 Dec 2018
  4. Study completion16 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03322566
Sponsor's protocol ID
KEYNOTE-715-06/ECHO-306-06
Other IDs
2017-001810-27, 2017
Status last verified
Jan 2022
First submitted
24 Oct 2017
Last updated
24 Jan 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boyer M, Hui R, Urban D, Clingan P, Su WC, Devaux C, Gadgeel S, Garassino M, Leopold L, Daniel J, Munteanu MC, Samkari A, Luo Y, Abreu DR. Pembrolizumab with platinum-based chemotherapy with or without epacadostat as first-line treatment for metastatic non-small cell lung cancer: a randomized, partially double-blind, placebo-controlled phase II study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1250. doi: 10.1186/s12885-022-10427-4.

    PubMed 39054462

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Epacadostat and Platinum-based chemotherapy in people with Lung Cancer, run by Incyte Corporation at 94 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Russia, Turkey (Türkiye), Canada, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo (time frame: Assessed every 12 weeks up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03322566, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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