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)

PHASE2CompletedINTERVENTIONAL
Enrollment

233

Participants

Timeline

Start Date

January 9, 2018

Primary Completion Date

December 13, 2018

Study Completion Date

October 16, 2020

Conditions
Lung Cancer
Interventions
DRUG

Pembrolizumab

Pembrolizumab administered intravenously every 3 weeks.

DRUG

Epacadostat

Epacadostat administered orally twice daily.

DRUG

Platinum-based chemotherapy

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

DRUG

Placebo

Matching placebo administered orally twice daily.

Trial Locations (94)

833

Chang Gung Medical Foundation, Kaohsiung Branch, Kaohsiung City

1121

Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest

2050

Chris OBrien Lifehouse, Camperdown

2145

The Crown Princess Mary Cancer Centre Westmead, Westmead

2148

Blacktown Hospital, Blacktown

2444

MNCCI Port Macquarie Base Hospital, Port Macquarie

2500

Southern Medical Day Care Centre, Wollongong

3529

CRU Hungary Kft., Miskolc

4870

Cairns Base Hospital, Cairns

5004

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet, Szolnok

5700

Bekes Megyei Pandy Kalman Korhaz, Gyula

8582

Veszprem Megyei Tudogyogyintezet, Farkasgyepű

8900

Zala Megyei Korhaz Pozvai Telephely, Pózva

10048

National Taiwan University Hospital, Taipei

10408

National Cancer Center, Goyang-si

12208

New York Oncology Hematology P.C, Albany

15224

Allegheny General Hospital, Pittsburgh

16059

Uludag Universitesi Tip Fakultesi, Bursa

18045

St. Luke's Hospital - Anderson Campus, Easton

20070

Pamukkale Unv. Tip Fak, Denizli

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia, Milan

20900

Ospedale San Gerardo - ASST Monza, Monza

21005

Hospital Juan Ramón Jimenez, Huelva

22908

Emily Couric Clinical Cancer Center, Charlottesville

24060

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

28046

Hospital Universitario La Paz, Madrid

33081

Centro Di Riferimento Oncologico, Aviano

33305

Chang Gung Medical Foundation, Linkou Branch, Taoyuan District

33486

Lynn Cancer Institute, Boca Raton

33705

Florida Cancer Specialists (North Region), St. Petersburg

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul

35016

Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria

35100

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

36526

Southern Cancer Center, PC, Daphne

37203

Tennessee Oncology, PLLC/The Sarah Cannon Research Institute, Nashville

37404

Tennessee Oncology, PLLC/The Sarah Cannon Research Institute, Chattanooga

40447

China Medical University Hospital, Taichung

45242

Oncology Hematology Care, Inc., Cincinnati

46026

Hospital Universitario La Fe, Valencia

46845

PPG-Oncology, Fort Wayne

48109

University of Michigan, Ann Arbor

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

52621

Chaim Sheba Medcal Center, Ramat Gan

55200

Samsun Medical Park Hastanesi, Samsun

55416

MMCORC, Saint Louis Park

59030

Namık Kemal University Medical Faculty, Tekirdağ

59102

St. Vincent Healthcare Frontier Cancer Center, Billings

68000

Oaxaca Site Management Organization S.C., Oaxaca City

70457

National Cheng Kung University Hospital, Tainan City

74133

Southwestern Regional Medical Center, Inc., Tulsa

76210

Texas Oncology-Denton South, Denton

85338

Western Regional Medical Center, Inc., Goodyear

85704

Arizona Oncology Associates PC- HOPE, Tucson

91900

FAICIC Clinical Research, Veracruz

95123

A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico, Catania

97070

Medical Care Research S.A. de C.V., Mérida

98109

Seattle Cancer Care Alliance, Seattle

121359

Central Clinical Hospital with polyclinic, Moscow

125284

Moscow Research Oncology Institute, Moscow

194291

SBHI Leningrad Regional Clinical Hospital, Saint Petersburg

308010

Belgorod Regional Oncology Dispensary, Belgorod

354057

Oncological Dispensary #2 of Ministry of Health of Krasnodar region, Sochi

357502

SBI of Stavropol region Pyatigorskiy Oncologic dispensary, Pyatigorsk

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH, Kazan'

426067

Udmurtia Republic Regional Clinical Oncology Dispensary, Izhevsk

443031

SBHI Samara Regional Clinical Oncology Dispensary, Samara

634028

Tomsk Scientific Research Institute of Oncology, Tomsk

1834111

Ha Emek Medical Center, Afula

3525408

Rambam Medical Center, Haifa

4428164

Meir Medical Center, Kfar Saba

5262000

Rabin Medical Center, Petah Tikva

8457108

Soroka Medical Center, Beersheba

33901-8101

Florida Cancer Specialists (South Region), Fort Myers

V1Y 5L3

BCCA-Cancer Centre of the Southern Interior, Kelowna

V7L 2L7

Lions Gate Hospital, North Vancouver

J4V 2H1

CISSS de la Monteregie-Centre, Greenfield Park

H7M 3L9

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

H3T 1M5

CIUSSS Ouest de l'Ile - St-Mary's Hospital, Montreal

H4J 1C5

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

G1R 2J6

CHU de Quebec - Hotel-Dieu de Quebec, Québec

G8Z 3R9

CIUSSS de la Mauricie-et-du-Centre-du-Quebec, Trois-Rivières

Dublin 4

St Vincents University Hospital, Dublin

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08980

Institut Catala Oncologia de Bellvitge - ICO, L'Hospitalet de Llobregat

01120

Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi, Adana

01330

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi, Adana

06100

Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara

HA6 2RN

Mount Vernon Cancer Centre, Northwood

EH42XU

Western General Hospital, Edinburgh

N18 1QX

North Middlesex Hospital, London

NE7 7DN

Freeman Hospital Newcastle upon Tyne Foundation NHS Trust, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Incyte Corporation

INDUSTRY

NCT03322566 - 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) | Biotech Hunter | Biotech Hunter