Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)

PHASE3CompletedINTERVENTIONAL
Enrollment

422

Participants

Timeline

Start Date

June 26, 2019

Primary Completion Date

August 11, 2023

Study Completion Date

August 22, 2024

Conditions
Metastatic Non-Small Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion of pembrolizumab at 200 mg

DRUG

Lenvatinib

Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.

DRUG

Docetaxel

IV infusion of docetaxel at 75 mg/m\^2.

Trial Locations (143)

1083

Semmelweis Egyetem.. ( Site 0604), Budapest

1121

Orszagos Koranyi Pulmonologiai Intezet ( Site 0603), Budapest

Orszagos Koranyi Pulmonologiai Intezet ( Site 0608), Budapest

2045

Tudogyogyintezet Torokbalint ( Site 0602), Törökbálint

2145

Westmead Hospital ( Site 0005), Westmead

2148

Blacktown Hospital ( Site 0004), Blacktown

2444

Port Macquarie Base Hospital ( Site 0003), Port Macquarie

2500

Southern Medical Day Care Centre ( Site 0001), Wollongong

3526

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601), Miskolc

3552

Bendigo Cancer Centre ( Site 0008), Bendigo

4102

Princess Alexandra Hospital - Division of Cancer Services ( Site 0002), Woolloongabba

5004

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610), Szolnok

5112

Calvary Central Districts Hospital ( Site 0007), Elizabeth Vale

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606), Székesfehérvár

8582

Veszprem Megyei Tudogyogyintezet ( Site 0607), Farkasgyepű

9024

Petz Aladar Megyei Oktato Korhaz ( Site 0609), Győr

10043

Ospedale San Luigi Gonzaga ( Site 0802), Orbassano

10065

Memorial Sloan-Kettering Cancer Center ( Site 1661), New York

10604

Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666), Harrison

11553

Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670), Uniondale

11725

Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662), Commack

11776

New York Cancer and Blood Specialists ( Site 1696), Port Jefferson Station

13585

Vivantes Klinikum Spandau ( Site 0505), Berlin

13620

Seoul National University Bundang Hospital ( Site 0204), Seongnam-si

14033

CHU Caen Service de Pneumologie ( Site 0401), Caen

14642

University of Rochester ( Site 1638), Rochester

19111

Fox Chase Cancer Center ( Site 1647), Philadelphia

20133

Istituto Nazionale dei Tumori ( Site 0806), Milan

20900

Ospedale San Gerardo - ASST Monza ( Site 0804), Monza

21237

Harry & Jeanette Weinberg Cancer Institute ( Site 1626), Baltimore

21239

Medstar Good Samaritan Hospital ( Site 1625), Baltimore

23007

Hospital Ciudad de Jaen ( Site 1000), Jaén

27100

Policlinico San Matteo - Fondazione IRCCS ( Site 0812), Pavia

28040

Hospital Universitario Fundacion Jimenez Diaz ( Site 1005), Madrid

28041

Hospital Universitario 12 de Octubre ( Site 1006), Madrid

28222

Hospital Universitario Puerta de Hierro ( Site 1007), Majadahonda

28223

Hospital Universitario Quiron Madrid ( Site 1012), Pozuelo de Alarcón

28644

Chungbuk National University Hospital ( Site 0201), Cheongju-si

32003

Cancer Specialists of North Florida - Fleming Island ( Site 1675), Fleming Island

32763

Mid-Florida Cancer Centers ( Site 1611), Orange City

33011

Hospital Central de Asturias ( Site 1002), Oviedo

35001

Hospital Universitario Insular de Gran Canaria ( Site 1011), Las Palmas de Gran Canaria

37916

Thompson Cancer Survival Center ( Site 1695), Knoxville

39008

Hospital Universitario Marques de Valdecilla ( Site 1003), Santander

40536

University of Kentucky School of Medicine & Hospitals ( Site 1621), Lexington

44109

MetroHealth Medical Center ( Site 1694), Cleveland

45220

TriHealth Cancer Institute ( Site 1672), Cincinnati

46010

Hospital Clinico de Valencia ( Site 1010), Valencia

49100

ICO Centre Paul Papin ( Site 0412), Angers

59063

Evangelisches Krankenhaus Hamm gGmbH ( Site 0504), Hamm

59101

Billings Clinic ( Site 1631), Billings

59715

Bozeman Health Deaconness Cancer Center ( Site 1632), Bozeman

62660

Clinique Ambroise Pare ( Site 0402), Beuvry

69126

Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501), Heidelberg

70124

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808), Bari

70809

Hematology Oncology Clinic ( Site 1680), Baton Rouge

72037

Centre Hospitalier Le Mans ( Site 0406), Le Mans

75005

Institut Curie ( Site 0400), Paris

75015

Hopital Europeen Georges Pompidou ( Site 0408), Paris

77090

Millenium Physicians ( Site 1690), Houston

83100

Azienda Ospedaliera San Giuseppe Moscati ( Site 0809), Avellino

84000

Centre Hospitalier General - Avignon ( Site 0407), Avignon

90146

A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810), Palermo

92140

HIA Percy-Clamart ( Site 0411), Clamart

93309

Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604), Bakersfield

95123

AOU Policlinico Vittorio Emanuele ( Site 0811), Catania

97227

Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644), Portland

105094

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905), Moscow

110221

Administradora Country SA - Clinica del Country ( Site 1307), Bogotá

110311

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304), Bogotá

121359

Central Clinical Hospital of the Administration of the President ( Site 0910), Moscow

195271

Railway Hospital of OJSC ( Site 0907), Saint Petersburg

197022

Pavlov First Saint Petersburg State Medical University ( Site 0917), Saint Petersburg

197758

GBUZ SPb CRPCstmc(o) ( Site 0921), Saint Petersburg

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903), Saint Petersburg

198255

SPb SBHI City Clinical Oncological Dispensary ( Site 0901), Saint Petersburg

200001

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305), Valledupar

230001

Oncomedica S.A. ( Site 1302), Montería

450054

GBUZ Republican Clinical Oncological Dispensary ( Site 0922), Ufa

644013

Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site, Omsk

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918), Krasnoyarsk

760042

Centro Medico Imbanaco de Cali S.A ( Site 1301), Santiago de Cali

3525408

Rambam Medical Center ( Site 0703), Haifa

4428132

Meir Medical Center ( Site 0702), Kfar Saba

4941492

Rabin Medical Center ( Site 0700), Petah Tikva

5262000

Chaim Sheba Medical Center ( Site 0704), Ramat Gan

6423906

Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705), Tel Aviv

8410101

Soroka Medical Center ( Site 0701), Beersheba

9013102

Shaare Zedek Medical Center-Oncology ( Site 0706), Jerusalem

02114

Massachusetts General Hospital ( Site 1622), Boston

01923

MGH - North Shore Cancer Center ( Site 1668), Danvers

02462

The Mass General Cancer Center at Newton-Wellesley ( Site 1692), Newton

01655

University of Massachusetts Medical School ( Site 1693), Worcester

07920

Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664), Basking Ridge

07748

Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665), Middletown

07645

Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667), Montvale

C1012AAR

Instituto de Investigaciones Metabolicas ( Site 2004), Caba

C1280AEB

Hospital Britanico de Buenos Aires ( Site 2002), Buenos Aires

S2000DSV

Sanatorio Parque ( Site 2005), Rosario

C1118AAT

Hospital Aleman ( Site 2000), Buenos Aires

C1431FWO

CEMIC ( Site 2003), Buenos Aires

R3E 0V9

CancerCare Manitoba ( Site 1504), Winnipeg

K7L 2V7

Kingston Health Sciences Centre ( Site 1503), Kingston

N6A 5W9

London Regional Cancer Program - London HSC ( Site 1505), London

M5G 2M9

Princess Margaret Cancer Centre ( Site 1502), Toronto

H3T 1M5

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501), Montreal

G1R 2J6

CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514), Québec

050030

Rodrigo Botero SAS ( Site 1300), Medellín

080020

Clinica de la Costa Ltda. ( Site 1309), Barranquilla

07548

SRH Wald-Klinikum Gera GmbH ( Site 0503), Gera

115 27

"General Hospital of Chest Diseases Sotiria ( Site 1703)", Athens

185 47

Metropolitan Hospital-4th Oncology Dept ( Site 1700), Athens

455 00

University Hospital of Ioannina ( Site 1701), Ioannina

570 01

European Interbalkan Medical Center ( Site 1704), Thessaloniki

00144

Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807), Rome

06132

Azienda Ospedaliera di Perugia ( Site 0805), Perugia

236-0051

Kanagawa Cardiovascular and Respiratory Center ( Site 0105), Yokohama

980-0873

Sendai Kousei Hospital ( Site 0107), Sendai

573-1191

Kansai Medical University Hospital ( Site 0104), Hirakata

260-8677

Chiba University Hospital ( Site 0106), Chiba

951-8566

Niigata Cancer Center Hospital ( Site 0101), Niigata

104-0045

National Cancer Center Hospital ( Site 0103), Tokyo

135-8550

The Cancer Institute Hospital of JFCR ( Site 0100), Tokyo

1769-001

Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801), Lisbon

4100-180

Hospital CUF Porto ( Site 1802), Porto

4200-072

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800), Porto

00674

Hematology and Oncology Institute ( Site 2105), Manatí

00717

Ad-Vance Medical Research LLC ( Site 2103), Ponce

00918

Puerto Rico Medical Research Center LLC ( Site 2101), San Juan

05505

Asan Medical Center ( Site 0203), Songpagu

03722

Severance Hospital Yonsei University Health System ( Site 0202), Seoul

08304

Consorci Hospitalari Mataro ( Site 1008), Mataró

08035

Hospital Universitari Vall d Hebron ( Site 1004), Barcelona

HU16 5JQ

Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108), Cottingham

NG5 1PB

Nottingham City Hospital Campus ( Site 1105), Nottingham

LE1 5WW

Leicester Royal Infirmary ( Site 1110), Leicester

N18 1QX

North Middlesex University Hospital NHS Trust ( Site 1109), London

SE1 9RT

Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102), London

HA6 2RN

Mount Vernon Cancer Centre ( Site 1107), Northwood

AB25 2ZN

Aberdeen Royal Infirmary ( Site 1114), Aberdeen

CV2 2DX

University Hospital Coventry and Warwickshire NHS Trust ( Site 1112), Coventry

B9 5SS

Birmingham Heartlands Hospital ( Site 1103), Birmingham

LS9 7TF

St James s University Hospital ( Site 1106), Leeds

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03976375 - Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008) | Biotech Hunter | Biotech Hunter