Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)

PHASE3CompletedINTERVENTIONAL
Enrollment

761

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

August 11, 2023

Study Completion Date

August 30, 2024

Conditions
Nonsquamous Non-small Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion Q3W

DRUG

Carboplatin

IV infusion Q3W

DRUG

Cisplatin

IV infusion Q3W

DRUG

Pemetrexed

IV infusion Q3W

DRUG

Lenvatinib

Oral capsule once daily

DRUG

Placebo matching lenvatinib

Oral capsule once daily

Trial Locations (158)

1023

Auckland City Hospital ( Site 0011), Auckland

2050

Chris OBrien Lifehouse ( Site 0006), Sydney

2145

Westmead Hospital ( Site 0009), Sydney

2148

Blacktown Hospital Western Sydney Local Health District ( Site 0008), Blacktown

2444

Port Macquarie Base Hospital ( Site 0001), Port Macquarie

3112

Tauranga Hospital ( Site 0004), Tauranga

3350

Ballarat Health Services ( Site 0003), Ballarat

4032

The Prince Charles Hospital ( Site 0010), Chermside

4870

Cairns Hospital ( Site 0002), Cairns

10408

National Cancer Center ( Site 0061), Goyang-si

13015

Hopital Nord du Marseille ( Site 0147), Marseille

13790

Broome Oncology, LLC ( Site 0562), Johnson City

15006

Complejo Hospitalario Universitario A Coruna ( Site 0239), A Coruña

16247

The Catholic University of Korea St. Vincent s Hospital ( Site 0064), Gyeonggi-do

19090

Abington Hospital - Asplundh Cancer Center ( Site 0575), Willow Grove

19107

Thomas Jefferson University Hospital ( Site 0548), Philadelphia

20251

Hamato-Onkologie Hamburg Prof. Laack und Partner ( Site 0161), Hamburg

22927

LungenClinic Grosshansdorf GmbH ( Site 0171), Großhansdorf

26121

Pius Hospital Oldenburg ( Site 0170), Oldenburg

26506

West Virginia University ( Site 0526), Morgantown

28009

Hospital General Universitario Gregorio Maranon ( Site 0237), Madrid

28040

Hospital Clinico San Carlos ( Site 0235), Madrid

28046

Hospital Universitario La Paz ( Site 0236), Madrid

28644

Chungbuk National University Hospital ( Site 0062), Cheongju-si

29010

Complejo Hospitalario de Malaga ( Site 0238), Málaga

33308

Holy Cross Hospital ( Site 0512), Fort Lauderdale

34070

Centre de Cancerologie du Grand Montpellier ( Site 0142), Montpellier

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0312), Istanbul

34722

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0310), Istanbul

35001

Hospital Universitario Insular de Gran Canaria ( Site 0244), Las Palmas de Gran Canaria

35100

Ege Universitesi Tip Fakultesi ( Site 0313), Izmir

38138

West Cancer Center - East Campus ( Site 0544), Germantown

42003

Mercy Health-Paducah Medical Oncology and Hematology ( Site 0570), Paducah

44093

Hopital Laennec ( Site 0146), Nantes

44280

Inonu Universitesi Medical Fakultesi ( Site 0318), Malatya

46014

Hospital General Universitario de Valencia ( Site 0231), Valencia

46026

Hospital Universitario La Fe ( Site 0233), Valencia

48202

Henry Ford Health System ( Site 0563), Detroit

50009

Hospital Universitario Miguel Servet ( Site 0242), Zaragoza

52074

Uniklinik RWTH Aachen ( Site 0160), Aachen

57070

Hopital Robert Schuman ( Site 0143), Vantoux

58122

Sanford Health Roger Maris Cancer Center ( Site 0533), Fargo

60488

Krankenhaus Nordwest ( Site 0169), Frankfurt am Main

64111

Saint Lukes Cancer Institute ( Site 0541), Kansas City

66421

Universitaetsklinikum des Saarlandes ( Site 0165), Homburg

67065

Centre Paul Strauss ( Site 0144), Strasbourg

69500

Hopital Cardiologique Louis Pradel ( Site 0141), Bron

69655

L'hopital Nord-Ouest - Centre Hospitalier de Villefranche sur Saone ( Site 0149), Villefranche-sur-Saône

70300

Shamir Medical Center-Assaf Harofeh ( Site 0227), Ẕerifin

73104

Stephenson Cancer Center ( Site 0504), Oklahoma City

73730

Klinikum Esslingen GmbH ( Site 0164), Esslingen am Neckar

75014

Hopital Cochin ( Site 0140), Paris

75235

Parkland Health & Hospital System ( Site 0576), Dallas

75390

UT Southwestern Medical Center ( Site 0558), Dallas

84106

Utah Cancer Specialists ( Site 0523), Salt Lake City

92151

Hopital Foch ( Site 0145), Suresnes

94040

El Camino Hospital Cancer Center ( Site 0529), Mountain View

97330

Good Samaritan Hospital Corvallis ( Site 0521), Corvallis

100006

Peking Union Medical College Hospital ( Site 0108), Beijing

100021

Cancer Hospital Chinese Academy of Medical Science ( Site 0117), Beijing

100036

Beijing Cancer Hospital ( Site 0120), Beijing

119049

City Clinical Hospital 1 na. NI. Pirogov ( Site 0270), Moscow

121359

Central Clinical Hospital with outpatient Clinic ( Site 0262), Moscow

125284

National Medical Research Radiology Centre ( Site 0260), Moscow

125367

FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0264), Moscow

130103

Jilin Cancer Hospital ( Site 0115), Changchun

143900

Moscow Regional Oncological Dispensary ( Site 0274), Balashikha

150081

The Third Affiliated Hospital of Harbin Medical University ( Site 0100), Harbin

197022

First Pavlov State Medical University of Saint Petersburg-Department of Oncology ( Site 0273), Saint Petersburg

197758

Leningrad Regional Oncology Center ( Site 0271), Saint Petersburg

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0269), Saint Petersburg

200032

Zhongshan Hospital Fudan University ( Site 0103), Shanghai

200443

Shanghai Pulmonary Hospital ( Site 0101), Shanghai

300060

Tianjin Medical University Cancer Institute & Hospital ( Site 0111), Tianjin

310003

The First Affiliated Hospital Zhejiang University ( Site 0109), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 0113), Hangzhou

325000

The First Affiliated Hospital of Wenzhou Medical University ( Site 0124), Wenzhou

350014

Fujian Provincial Cancer Hospital ( Site 0102), Fuzhou

400037

The Second Hospital Affiliated to AMU ( Site 0119), Chongqing

400038

First Affiliated Hospital of The Third Military Medical University ( Site 0118), Chongqing

420029

SAHI Republican Clinical Oncological Dispensary of the MoH of RT ( Site 0261), Kazan'

430022

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0123), Wuhan

430079

Hubei Cancer Hospital ( Site 0122), Wuhan

450008

Henan Cancer Hospital ( Site 0112), Zhengzhou

510515

Southern Medical University Nanfang Hospital ( Site 0121), Guangzhou

603081

Nizhniy Novgorod Region Oncology Dispensary ( Site 0272), Nizhny Novgorod

644013

Omsk Clinical Oncology Dispensary ( Site 0267), Omsk

830000

Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110), Urumuqi

1240000

Centro Oncologico Antofagasta ( Site 0386), Antofagasta

1641101

Holy Family Hospital ( Site 0228), Nazareth

2520598

Oncocentro ( Site 0384), Viña del Mar

3109601

Rambam Medical Center ( Site 0223), Haifa

3465584

Clinica Universidad Catolica del Maule ( Site 0385), Talca

4428164

Meir Medical Center ( Site 0221), Kfar Saba

4810218

Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0380), Temuco

4941492

Rabin Medical Center ( Site 0224), Petah Tikva

5262000

Sheba Medical Center ( Site 0220), Ramat Gan

6423906

Sourasky Medical Center ( Site 0225), Tel Aviv

7500713

OrlandiOncologia ( Site 0381), Santiago

7500921

Fundacion Arturo Lopez Perez FALP ( Site 0383), Santiago

8330032

Pontificia Universidad Catolica de Chile ( Site 0382), Santiago

8410101

Soroka Medical Center ( Site 0222), Beersheba

8420383

Bradford Hill Centro de Investigaciones Clinicas ( Site 0387), Santiago

9013102

Shaare Zedek Medical Center-Oncology ( Site 0229), Jerusalem

06520-8028

Yale University ( Site 0519), New Haven

B1884BBF

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0367), Berazategui

B7600FZO

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0371), Mar del Plata

C1431FWO

CEMIC ( Site 0370), Buenos Aires

S2000DSV

Sanatorio Parque ( Site 0365), Rosario

C1118AAT

Hospital Aleman ( Site 0368), Buenos Aires

C1426ANZ

Instituto Medico Especializado Alexander Fleming ( Site 0369), Buenos Aires

X5008HHW

CEMAIC ( Site 0374), Córdoba

J5402DIL

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0372), San Juan

E1C 6Z8

Moncton Hospital - Horizon Health Network ( Site 0410), Moncton

L8V 1C3

Juravinski Cancer Centre ( Site 0407), Hamilton

K7L 2V7

Kingston Health Sciences Centre ( Site 0414), Kingston

L1G 2B9

Lakeridge Health ( Site 0406), Oshawa

P6B 0A8

Sault Area Hospital ( Site 0413), Sault Ste. Marie

H7M 3L9

Hopital Cite de la Sante de Laval ( Site 0400), Laval

H3T 1M5

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0412), Montreal

G1R 2J6

CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0403), Québec

G8Z 3R9

CIUSSS de la Mauricie et du Centre du Quebec ( Site 0408), Trois-Rivières

06120

Krankenhaus Martha Maria Halle-Doelau ( Site 0166), Halle

460-0001

National Hospital Organization Nagoya Medical Center ( Site 0017), Nagoya

470-1192

Fujita Health University Hospital ( Site 0016), Toyoake

277-8577

National Cancer Center Hospital East ( Site 0024), Kashiwa

920-8641

Kanazawa University Hospital ( Site 0018), Kanazawa

583-8588

Osaka Habikino Medical Center ( Site 0020), Habikino

573-1191

Kansai Medical University Hospital ( Site 0022), Hirakata

951-8566

Niigata Cancer Center Hospital ( Site 0019), Niigata

104-0045

National Cancer Center Hospital ( Site 0026), Tokyo

113-8677

Tokyo Metropolitan Komagome Hospital ( Site 0015), Tokyo

135-8550

The Cancer Institute Hospital of JFCR ( Site 0021), Tokyo

641-8510

Wakayama Medical University Hospital ( Site 0025), Wakayama

63-300

Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 0615), Pleszew

60-693

MED-POLONIA Sp. z o.o. ( Site 0609), Poznan

85-796

Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0601), Bydgoszcz

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0603), Warsaw

75-581

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0602), Koszalin

93-513

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 0613), Lodz

03722

Severance Hospital Yonsei University Health System ( Site 0063), Seoul

08907

ICO L Hospitalet ( Site 0234), L'Hospitalet de Llobregat

03010

Hospital General Universitario de Alicante ( Site 0240), Alicante

08025

Hospital Santa Creu i Sant Pau ( Site 0241), Barcelona

01330

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0314), Adana

06100

Hacettepe Universitesi Tıp Fakultesi ( Site 0316), Ankara

06620

Ankara Universitesi Tip Fakultesi. ( Site 0317), Ankara

06800

Ankara Sehir Hastanesi ( Site 0323), Ankara

CB2 0QQ

Cambridge University Hospitals NHS Trust ( Site 0293), Cambridge

N18 1QX

North Middlesex University Hospital NHS Trust ( Site 0291), London

SE1 9RT

Guys and St Thomas NHS Foundation Trust ( Site 0280), London

SW17 0QT

St Georges University Hospitals NHS Foundation Trust. ( Site 0292), London

AB25 2ZN

Aberdeen Royal Infirmary ( Site 0288), Aberdeen

LS9 7TF

Leeds Teaching Hospital NHS Trust. St. James University Hospital ( Site 0276), Leeds

LE1 5WW

Leicester Royal Infirmary ( Site 0284), Leicester

M20 4BX

Christie NHS Foundation Trust ( Site 0275), Manchester

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0286), Metropolitan Borough of Wirral

NG5 1PB

Nottingham City Hospital Campus ( Site 0287), Nottingham

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03829319 - Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006) | Biotech Hunter | Biotech Hunter