Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)

PHASE3CompletedINTERVENTIONAL
Enrollment

623

Participants

Timeline

Start Date

March 13, 2019

Primary Completion Date

May 19, 2021

Study Completion Date

April 24, 2024

Conditions
Non-small Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Lenvatinib

oral capsule

DRUG

Placebo for lenvatinib

oral capsule

Trial Locations (162)

112

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091), Taipei

Taipei Veterans General Hospital ( Site 0089), Taipei

235

Taipei Medical University Shuang Ho Hospital ( Site 0090), New Taipei City

300

National Taiwan University Hospital Hsin-Chu Branch ( Site 0087), Hsinchu

1083

Semmelweis Egyetem ( Site 0210), Budapest

2045

Tudogyogyintezet Torokbalint ( Site 0205), Törökbálint

2500

Wollongong Private Hospital ( Site 0005), Wollongong

2800

Orange Health Services ( Site 0002), Orange

3355

Ballarat Oncology and Haematology Services ( Site 0008), Wendouree

3529

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202), Miskolc

CRU Hungary KFT ( Site 0209), Miskolc

4032

The Prince Charles Hospital ( Site 0011), Chermside

5000

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203), Szolnok

5700

Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207), Gyula

6150

St John of God Murdoch Medical Clinic ( Site 0001), Perth

7400

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217), Kaposvár

9024

Petz Aladar Megyei Oktato Korhaz ( Site 0213), Győr

10002

National Taiwan University Hospital ( Site 0088), Taipei

10050

Gleneagles Penang ( Site 0066), Pulau Pinang

10990

Hospital Pulau Pinang. ( Site 0065), George Town

11312

AS Ida-Tallinna Keskhaigla ( Site 0161), Tallinn

13419

SA Pohja-Eesti Regionaalhaigla ( Site 0162), Tallinn

13620

Seoul National University Bundang Hospital ( Site 0075), Seongnam-si

14050

Medica Sur S.A.B de C.V. ( Site 0384), Mexico City

14080

Instituto Nacional de Cancerologia. ( Site 0382), Mexico City

18009

Cherkasy Regional Hospital ( Site 0336), Cherkasy

21029

Podillya Regional Center of Oncology ( Site 0343), Vinnytsia

21401

Anne Arundel Medical Center Oncology and Hematology ( Site 0514), Annapolis

25000

CHU Jean Minjoz ( Site 0167), Besançon

25011

Ukranian Center of TomoTherapy ( Site 0344), Kropyvnytskiy

25100

Hospital Tengku Ampuan Afzan ( Site 0062), Kuantan

27403

Cone Health Cancer Center at Alamance Regional ( Site 0527), Greensboro

28644

Chungbuk National University Hospital ( Site 0079), Cheongju-si

30060

Northwest Georgia Oncology Centers PC ( Site 0518), Marietta

32803

Florida Hospital ( Site 0526), Orlando

33081

Centro di Riferimento Oncologico CRO ( Site 0235), Aviano

34090

ICM Val D Auerelle ( Site 0177), Montpellier

35340

Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314), Izmir

38700

CHU de Grenoble - Hopital Michallon ( Site 0169), La Tronche

40536

University of Kentucky School of Medicine & Hospitals ( Site 0517), Lexington

42080

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321), Konya

43701

Genesis Cancer Care Center ( Site 0559), Zanesville

44033

Ulsan University Hospital ( Site 0077), Ulsan

44680

Consultorios de Medicina Especializada del Sector Privado ( Site 0388), Guadalajara

44805

Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185), Saint-Herblain

46050

Beacon Hospital Sdn Bhd ( Site 0067), Petaling Jaya

46845

Parkview Cancer Center ( Site 0542), Fort Wayne

48121

Ospedale Santa Maria delle Croci ( Site 0232), Ravenna

49102

City Clinical Hosp.4 of DCC ( Site 0338), Dnipro

49684

Munson Medical Center ( Site 0512), Traverse City

50134

A.O. Universitaria Careggi ( Site 0236), Florence

50406

SA Tartu Ulikooli Kliinikum ( Site 0160), Tartu

54290

Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323), Sakarya

55200

Samsun Medical Park Hastanesi ( Site 0320), Samsun

55426

Park Nicollet Frauenshuh Cancer Center ( Site 0554), Saint Louis Park

59100

University Malaya Medical Centre ( Site 0061), Kuala Lumpur

59101

Billings Clinic Cancer Center ( Site 0508), Billings

61070

Regional Centre of Oncology-Thoracic organs ( Site 0337), Kharkiv

61615

Illinois Cancer Care, PC ( Site 0557), Peoria

62250

Institut Kanser Negara - National Cancer Institute ( Site 0063), Putrajaya

64109

Centre Hospitalier de la Cote Basque ( Site 0173), Bayonne

65055

MI Odessa Regional Oncological Centre ( Site 0333), Odesa

65212

University of Missouri Health Care ( Site 0555), Columbia

68000

Oaxaca Site Management Organization SC ( Site 0389), Oaxaca City

70457

National Cheng Kung University Hospital ( Site 0086), Tainan City

75248

Institut Curie ( Site 0166), Paris

76000

CHU de Rouen ( Site 0174), Rouen

76018

MI Precarpathian Clinical Oncology Center ( Site 0346), Ivano-Frankivsk

76504

Central Texas Veterans Healthcare System ( Site 0533), Temple

79031

Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341), Lviv

80054

CHU Amiens Sud ( Site 0182), Amiens

83056

Centre hospitalier Toulon Sainte-Musse ( Site 0172), Toulon

83100

Azienda Ospedaliera San Giuseppe Moscati ( Site 0234), Avellino

85224

Ironwood Cancer & Research Centers ( Site 0541), Chandler

88100

Universita Magna Grecia ( Site 0230), Catanzaro

89440

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381), Madero

92037

Scripps Cancer Center ( Site 0521), La Jolla

92210

Institut Curie - Centre Rene Huguenin ( Site 0181), Saint-Cloud

93309

CBCC Global Research, Inc. ( Site 0532), Bakersfield

93586

Sarawak General Hospital ( Site 0064), Kuching

97239

Oregon Health Sciences University ( Site 0544), Portland

98039

Presidio Ospedaliero San Vincenzo ( Site 0231), Taormina

99503

Alaska Clinical Research Center ( Site 0511), Anchorage

100006

Peking Union Medical College Hospital ( Site 0105), Beijing

100036

Beijing Cancer Hospital ( Site 0102), Beijing

101149

Beijing Chest Hospital Capital Medical University ( Site 0111), Beijing

130021

The First Hospital of Jilin University ( Site 0110), Changchun

194291

SBHI Leningrad Regional Clinical Hospital ( Site 0263), Saint Petersburg

195271

Railway Hospital of OJSC ( Site 0268), Saint Petersburg

198255

City Clinical Oncology Center ( Site 0260), Saint Petersburg

200001

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374), Valledupar

200433

Zhongshan Hospital Fudan University ( Site 0100), Shanghai

210009

Jiangsu Cancer Hospital ( Site 0101), Nanjing

230000

Shanghai Chest Hospital ( Site 0112), Shanghai

230001

Anhui Provincial Hospital ( Site 0108), Hefei

230002

Oncomedica S.A. ( Site 0372), Montería

230088

The First Affiliated Hospital of Anhui Medical University ( Site 0113), Hefei

310003

The First Affiliated Hospital Zhejiang University ( Site 0106), Hangzhou

310006

Hangzhou First People's Hospital ( Site 0109), Hangzhou

310009

2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 0116), Hangzhou

410008

Xiangya Hospital of Central South University ( Site 0115), Changsha

410013

Hunan Cancer Hospital ( Site 0104), Changsha

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269), Kazan'

443031

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265), Samara

450054

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262), Ufa

510115

West China Hospital of Sichuan University ( Site 0117), Chengdu

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266), Krasnoyarsk

710061

1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103), XiAn

760023

Centro Medico Imbanaco de Cali S.A ( Site 0369), Santiago de Cali

3109601

Rambam Medical Center ( Site 0223), Haifa

3339419

Bnei Zion Medical Center ( Site 0227), Haifa

4428132

Meir Medical Center ( Site 0221), Kfar Saba

4941492

Rabin Medical Center ( Site 0224), Petah Tikva

5266202

Sheba Medical Center ( Site 0220), Ramat Gan

6423906

Sourasky Medical Center ( Site 0225), Tel Aviv

7830604

Barzilai Medical Center ( Site 0226), Ashkelon

8457108

Soroka Medical Center ( Site 0222), Beersheba

T6G 1Z2

Cross Cancer Institute ( Site 0400), Edmonton

V7L 2L7

Lions Gate Hospital ( Site 0407), North Vancouver

L6R 3J7

William Osler Health System (Brampton Civic Hospital) ( Site 0402), Brampton

N8W 2X3

Windsor Regional Cancer Program ( Site 0404), Windsor

H4A 3J1

McGill University Health Centre ( Site 0418), Montreal

050015

Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368), Medellín

050021

Fundacion Centro de Investigacion Clinica CIC ( Site 0366), Medellín

080002

Biomelab S A S ( Site 0365), Barranquilla

00185

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233), Rome

00168

Policlinico Gemelli di Roma ( Site 0237), Roma

464-8681

Aichi Cancer Center Hospital ( Site 0018), Nagoya

830-0011

Kurume University Hospital ( Site 0025), Kurume

673-8558

Hyogo Cancer Center ( Site 0021), Akashi

236-0051

Kanagawa Cardiovascular and Respiratory Center ( Site 0026), Yokohama

241-8515

Kanagawa Cancer Center ( Site 0023), Yokohama

981-1293

Miyagi Cancer Center ( Site 0028), Natori-shi

980-0873

Sendai Kousei Hospital ( Site 0022), Sendai

591-8555

National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027), Sakai

589-8511

Kindai University Hospital ( Site 0017), Sayama

810-8563

National Hospital Organization Kyushu Medical Center ( Site 0015), Fukuoka

812-8582

Kyushu University Hospital ( Site 0030), Fukuoka

700-8558

Okayama University Hospital ( Site 0020), Okayama

541-8567

Osaka International Cancer Institute ( Site 0019), Osaka

105-8470

Toranomon Hospital ( Site 0016), Tokyo

113-8431

Juntendo University Hospital ( Site 0029), Tokyo

113-8603

Nippon Medical School Hospital ( Site 0024), Tokyo

64-920

Ars Medical Sp. z o.o. ( Site 0254), Piła

31-202

Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253), Krakow

31-826

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243), Krakow

65-046

Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247), Zielona Góra

07-410

Centrum Medyczne Pratia Ostroleka ( Site 0242), Ostrołęka

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252), Warsaw

37-700

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250), Przemyśl

99-153

SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256), Lodz

05505

Asan Medical Center ( Site 0076), Seoul

07061

SMG-SNU Boramae Medical Center ( Site 0078), Seoul

06010

Gulhane Egitim ve Arastirma Hastanesi ( Site 0316), Ankara

06200

Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318), Ankara

06490

Baskent Universitesi Ankara Hastanesi ( Site 0319), Ankara

07020

Antalya Memorial Hospital Department of Medical Oncology ( Site 0324), Antalya

07070

Akdeniz Universitesi Tip Fakultesi ( Site 0322), Antalya

03039

Medical Center Verum ( Site 0334), Kyiv

03115

Kyiv City Clinical Oncology Centre ( Site 0339), Kyiv

03126

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331), Kyiv

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03829332 - Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007) | Biotech Hunter | Biotech Hunter