Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

797

Participants

Timeline

Start Date

April 24, 2018

Primary Completion Date

July 10, 2023

Study Completion Date

June 29, 2026

Conditions
Non-small Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab

200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.

DRUG

Placebo

Normal saline by IV infusion Q3W, given on cycle day 1.

DRUG

Cisplatin

75 mg/m\^2 by IV infusion Q3W, given on cycle day 1.

DRUG

Gemcitabine

1000 mg/m\^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.

DRUG

Pemetrexed

500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.

Trial Locations (227)

112

Taipei Veterans General Hospital ( Site 0722), Taipei

114

Tri-Service General Hospital ( Site 0726), Taipei

333

Chang Gung Medical Foundation.Linkou Branch ( Site 0723), Taoyuan District

1002

Pauls Stradins Clinical University Hospital ( Site 0911), Riga

1079

Riga East Clinical University Hospital ( Site 0912), Riga

2145

Westmead Hospital ( Site 0621), Westmead

2193

Wits Clinical Research ( Site 0570), Parktown-Johannesburg

2800

Orange Health Services ( Site 0624), Orange

AZ Sint-Maarten ( Site 0226), Mechelen

3000

UZ Leuven ( Site 0221), Leuven

4000

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223), Liège

4001

The Oncology Centre ( Site 0571), Durban

5016

Hospital Privado Universitario de Córdoba ( Site 0139), Córdoba

7570

Cape Town Oncology Trials Pty Ltd ( Site 0572), Kraaifontein

8800

AZ Delta ( Site 0222), Roeselare

9000

UZ Gent ( Site 0224), Ghent

9100

AZ Nikolaas ( Site 0225), Sint-Niklaas

10043

AOU San Luigi Gonzaga di Orbassano ( Site 0313), Orbassano

10048

National Taiwan University Hospital ( Site 0721), Taipei

10065

Memorial Sloan Kettering Cancer Center ( Site 0060), New York

10408

National Cancer Center ( Site 0702), Gyeonggi-do

10461

Montefiore Einstein Center ( Site 0016), The Bronx

10601

White Plains Hospital Center for Cancer Care ( Site 0007), White Plains

10604

Memorial Sloan Kettering Cancer Center Westchester ( Site 0079), Harrison

11553

Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078), Uniondale

11725

Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076), Commack

12208

St. Peter's Hospital Cancer Care Center ( Site 0039), Albany

13125

Evangelische Lungenklinik Berlin ( Site 0274), Berlin

13419

SA Pohja-Eesti Regionaalhaigla ( Site 1100), Tallinn

14165

HELIOS Klinikum Emil von Behring ( Site 0280), Berlin

15212

Allegheny General Hospital ( Site 0009), Pittsburgh

15232

UPMC Hillman Cancer Centers ( Site 0041), Pittsburgh

15240

VA Pittsburgh Healthcare System ( Site 0052), Pittsburgh

16247

The Catholic University of Korea St. Vincent s Hospital ( Site 0705), Gyeonggi-do

17007

Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386), Girona

17109

UPMC Pinnacle Health System - East Location ( Site 0063), Harrisburg

18009

Cherkassy Regional Oncological Center ( Site 0613), Cherkasy

19124

Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053), Philadelphia

19718

Helen F. Graham Cancer Center & Research Institute ( Site 0015), Newark

20089

Istituto Clinico Humanitas Research Hospital ( Site 0314), Rozzano

20132

IRCCS Ospedale San Raffaele di Milano ( Site 0303), Milan

20133

Istituto Nazionale Tumori ( Site 0309), Milano

20162

ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315), Milan

20900

Azienda Ospedaliera San Gerardo ( Site 0308), Monza

21075

Asklepios Klinikum Hamburg ( Site 0271), Hamburg

21237

Harry & Jeanette Weinberg Cancer Institute ( Site 0081), Baltimore

22031

Inova Schar Cancer Institute ( Site 0032), Fairfax

Virginia Cancer Specialists, PC ( Site 0080), Fairfax

22903

Emily Couric Clinical Cancer Center ( Site 0013), Charlottesville

22927

LungenClinic Grosshansdorf GmbH ( Site 0267), Großhansdorf

24105

Universitaetsklinikum Schleswig Holstein ( Site 0871), Kiel

25006

PP PPC Acinus Medical and Diagnostic Centre ( Site 0609), Kropyvnytsky

25123

Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307), Brescia

28009

Hospital General Universitario Gregorio Maranon ( Site 0382), Madrid

29607

Saint Francis Cancer Center ( Site 0096), Greenville

30265

Southeastern Regional Medical Center ( Site 0051), Newnan

31100

CHU de Toulouse - Hopital Larrey ( Site 0258), Toulouse

32224

Mayo Clinic Jacksonville ( Site 0022), Jacksonville

33176

Miami Cancer Institute-Baptist Hospital ( Site 0068), Miami

34376

LKI Lungenfachklinik Immenhausen ( Site 0268), Immenhausen

35001

Hospital Universitario Insular de Gran Canaria ( Site 0383), Las Palmas de Gran Canaria

40447

China Medical University Hospital ( Site 0724), Taichung

40489

Florence Nightingale Krankenhaus ( Site 0874), Düsseldorf

41013

Hospital Virgen del Rocio ( Site 0387), Seville

41101

Ashland-Bellefonte Cancer Center ( Site 0021), Ashland

46845

PPG-Oncology ( Site 0043), Fort Wayne

47014

IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300), Meldola

48202

Henry Ford Health System ( Site 0031), Detroit

48431

Mathias Spital Rheine ( Site 0261), Rheine

48912

Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034), Lansing

49102

City Clinical Hosp.4 of DCC ( Site 0607), Dnipro

50161

LSMUL Kauno Klinikos ( Site 0932), Kaunas

52242

University of Iowa Hospital and Clinics ( Site 0010), Iowa City

55905

Mayo Clinic ( Site 0026), Rochester

56073

Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873), Koblenz

58675

Lungenklinik Hemer ( Site 0269), Hemer

59100

University Malaya Medical Centre ( Site 0781), Kuala Lumpur

59102

St. Vincent Healthcare Frontier Cancer Center ( Site 0005), Billings

60007

Northwest Oncology and Hematology ( Site 0001), Elk Grove Village

60426

Ingalls Memorial Hospital ( Site 0044), Harvey

65055

MI Odessa Regional Oncological Centre ( Site 0608), Odesa

67091

Nouvel Hopital Civil ( Site 0255), Strasbourg

69040

Zaporizhzhya Regional Clinical Oncology Center ( Site 0606), Zaporizhzhya

69310

Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241), Pierre-Bénite

73000

MI KhRC Kherson Regional Oncology Dispensary ( Site 0614), Kherson

73011

Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245), Chambéry

73730

Klinikum Esslingen GmbH ( Site 0875), Esslingen am Neckar

74133

Southwestern Regional Medical Center, Inc. ( Site 0054), Tulsa

74374

Centre Hospitalier Annecy Genevois ( Site 0242), Pringy

75248

Institut Curie ( Site 0250), Paris

76018

MI Precarpathian Clinical Oncology Center ( Site 0603), Ivano-Frankivsk

76031

CHU de Rouen ( Site 0252), Rouen

80131

Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301), Napoli

83301

Kaohsiung Chang Gung Memorial Hospital ( Site 0725), Kaohsiung City

83800

H.I.A. Sainte-Anne ( Site 0251), Toulon

85004

University of Arizona Cancer Center - Dignity Health ( Site 0062), Phoenix

85234

Banner MD Anderson Cancer Center ( Site 0028), Gilbert

85338

Western Regional Medical Center, Inc. ( Site 0050), Goodyear

85724

University of Arizona Cancer Center ( Site 0012), Tucson

87039

Clinique Francois Chenieux ( Site 0246), Limoges

90404

John Wayne Cancer Institute ( Site 0049), Santa Monica

91505

Providence Saint Joseph Medical Center ( Site 0061), Burbank

92150

Hopital Foch ( Site 0243), Suresnes

92801

Pacific Cancer Medical Center, Inc. ( Site 0004), Anaheim

93000

Hôpital Avicenne - Service d oncologie medicale ( Site 0249), Bobigny

93586

Sarawak General Hospital ( Site 0782), Kuching

93940

Pacific Cancer Care ( Site 0035), Monterey

94305

Stanford University, Stanford Cancer Center ( Site 0046), Stanford

95403

St Joseph Heritage Healthcare ( Site 0040), Santa Rosa

97239

OHSU Center for Health & Healing ( Site 1006), Portland

98201

Providence Regional Cancer Partnership ( Site 0065), Everett

99437

Zentralklinik Bad Berka GmbH ( Site 0264), Bad Berka

100010

Beijing Cancer Hospital ( Site 0810), Beijing

Beijing Cancer Hospital ( Site 0811), Beijing

100021

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801), Beijing

100191

Peking University Third Hospital ( Site 0812), Beijing

100730

Peking Union Medical College Hospital ( Site 0809), Beijing

115478

N.N. Blokhin NMRCO ( Site 0521), Moscow

125284

National Medical Research Radiology Centre ( Site 0535), Moscow

125367

Medical Rehabilitation Center ( Site 0534), Moscow

194291

SBHI Leningrad Regional Clinical Hospital ( Site 0524), Saint Petersburg

197758

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533), Saint Petersburg

198255

Municipal Clinical Oncology Center ( Site 0523), Saint Petersburg

200032

Fudan University Shanghai Cancer Center ( Site 0813), Shanghai

Zhongshan Hospital of Fudan University ( Site 0808), Shanghai

200347

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504), Craiova

200433

Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817), Shanghai

300052

Tianjin Medical University General Hospital ( Site 0806), Tianjin

300166

S C Oncocenter Oncologie Medicala S R L ( Site 0505), Timișoara

310003

The First Affiliated Hospital of Zhejiang University ( Site 0804), Hangzhou

310022

Zhejiang Cancer Hospital.... ( Site 0814), Hangzhou

315010

Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802), Ningbo

400015

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501), Cluj-Napoca

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515), Cluj-Napoca

407280

SC Radiotherapy Center Cluj SRL ( Site 0509), Comuna Floresti

410013

Hunan Cancer Hospital ( Site 0815), Changsha

410450

S C Pelican Impex SRL ( Site 0506), Oradea

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529), Kazan'

454087

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530), Chelyabinsk

500091

Spitalul Sf. Constantin ( Site 0512), Brasov

510060

Sun Yat-Sen University Cancer Center ( Site 0816), Guangzhou

634028

Tomsk Scientific Research Institute of Oncology ( Site 0526), Tomsk

710038

Tang Du Hospital ( Site 0803), Xi’an

720237

Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503), Suceava

900591

Spitalul clinic Judetean de urgenta Constanta ( Site 0508), Constanța

06102

Hartford Hospital ( Site 0069), Hartford

02118

Boston Medical Center ( Site 0057), Boston

01655

UMass Memorial Medical Center ( Site 0030), Worcester

68198-7680

University of Nebraska Medical Center ( Site 0047), Omaha

07920

Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074), Basking Ridge

07748

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077), Middletown

07645

MSKCC-Bergen ( Site 0075), Montvale

11794-9447

Stony Brook University Medical Center - Cancer Center ( Site 0019), Stony Brook

B1884BBF

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136), Berazategui

B7602CBM

Hospital Privado de Comunidad. ( Site 0130), Mar del Plata

B1629ODT

Hospital Universitario Austral ( Site 0127), Pilar

C1093AAS

Fundacion Favaloro ( Site 0128), Ciudad de Buenos Aires

S2000CVB

Sanatorio Britanico ( Site 0125), Rosario

S2000DSV

Sanatorio Parque ( Site 0135), Rosario

S2002KDS

Hospital Provincial del Centenario ( Site 0131), Rosario

X5000JHQ

Sanatorio Allende ( Site 0129), Córdoba

J5402DIL

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133), San Juan

60336-232

Centro Regional Integrado de Oncologia ( Site 0160), Fortaleza

60430-230

Instituto do Cancer do Ceara ( Site 0152), Fortaleza

70200-730

Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159), Brasília

59075-740

Liga Norte Riograndense Contra o Cancer ( Site 0150), Natal

98700 000

Hospital de Caridade de Ijui ( Site 0153), Ijuí

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146), Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao ( Site 0145), Porto Alegre

88020-210

YNOVA Pesquisa Clinica ( Site 0823), Florianópolis

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144), Barretos

20230-130

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149), Rio de Janeiro

01321-001

Hospital Paulistano - Amil Clinical Research ( Site 0822), São Paulo

01327-001

Hospital Alemao Oswaldo Cruz ( Site 0158), São Paulo

M5G 2M9

Princess Margaret Cancer Centre ( Site 0109), Toronto

G7H 5H6

CIUSSS du Saguenay-Lac-St-Jean ( Site 0101), Chicoutimi

H2X 0C1

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110), Montreal

H3T 1M5

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104), Montreal

H4A 3J1

McGill University Health Centre ( Site 0111), Montreal

01307

Universitaetsklinikum Carl Gustav Carus ( Site 0273), Dresden

04103

Universitaetsklinikum Leipzig AOeR ( Site 0277), Leipzig

07548

SRH Waldklinikum Gera GmbH ( Site 0272), Gera

Unknown

Cork University Hospital ( Site 0452), Wilton

D08 K0Y5

St James Hospital ( Site 0451), Dublin

V98F858

Mid Western Cancer Centre ( Site 0450), Limerick

00152

Azienda Ospedaliera San Camillo Forlanini ( Site 0311), Roma

464-8681

Aichi Cancer Center Hospital ( Site 0765), Nagoya

277-8577

National Cancer Center Hospital East ( Site 0761), Kashiwa

807-8556

HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770), Kitakyushu

673-8558

Hyogo Cancer Center ( Site 0764), Akashi

216-8511

St. Marianna University School of Medicine Hospital ( Site 0769), Kawasaki

241-8515

Kanagawa Cancer Center ( Site 0763), Yokohama

879-5593

Oita University Hospital ( Site 0766), Yufu

960-1295

Fukushima Medical University Hospital ( Site 0772), Fukushima

734-8551

Hiroshima University Hospital ( Site 0762), Hiroshima

104-0045

National Cancer Center Hospital ( Site 0767), Tokyo

113-8431

Juntendo University Hospital ( Site 0768), Tokyo

160-0023

Tokyo Medical University Hospital ( Site 0771), Tokyo

08406

Nacionalinis Vezio Institutas ( Site 0931), Vilnius

60-569

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487), Poznan

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488), Bydgoszcz

43-360

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484), Bystra

53-413

Dolnoslaskie Centrum Onkologii. ( Site 0491), Wroclaw

82-550

Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483), Prabuty

93-513

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493), Lodz

010626

Centrul Medical Medicover Victoria ( Site 0514), Bucharest

075100

S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511), Otopeni

014461

Euroclinic Hospital Bucharest ( Site 0510), Bucharest

021389

S.C.Focus Lab Plus S.R.L ( Site 0513), Bucharest

0081

Wilgers Oncology Centre ( Site 0573), Pretoria

05505

Asan Medical Center ( Site 0701), Seoul

06351

Samsung Medical Center ( Site 0704), Seoul

07071

SMG-SNU Boramae Medical Center ( Site 0707), Seoul

08916

Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381), Badalona

08908

Instituto Catalan de Oncologia - ICO ( Site 0388), L'Hospitalet de Llobregat

08025

Hospital de la Santa Creu i Sant Pau ( Site 0385), Barcelona

08035

Hospital Universitari Vall d Hebron ( Site 0389), Barcelona

03022

National Cancer Institute of the MoH of Ukraine ( Site 0605), Kyiv

03115

Kyiv City Clinical Oncological Center ( Site 0601), Kyiv

LE1 5WW

Leicester Royal Infirmary ( Site 0447), Leicester

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456), Metropolitan Borough of Wirral

SW3 6JJ

Royal Marsden NHS Foundation Trust ( Site 0458), London

SM2 5PT

Royal Marsden Hospital ( Site 0457), Sutton

NG5 1PB

Nottingham City Hospital Campus ( Site 0441), Nottingham

B9 5SS

Heartlands Hospital in Birmingham ( Site 0455), Birmingham

NE7 7DN

Freeman Hospital ( Site 0444), Newcastle upon Tyne

PL6 8DH

Plymouth Hospitals NHS Trust ( Site 0443), Plymouth

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY