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)

November 14, 2024 updated by: Merck Sharp & Dohme LLC

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

797

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5016
        • Hospital Privado Universitario de Córdoba ( Site 0139)
      • Cordoba, Argentina, X5000JHQ
        • Sanatorio Allende ( Site 0129)
      • San Juan, Argentina, J5402DIL
        • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, B1884BBF
        • Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
      • Mar del Plata, Buenos Aires, Argentina, B7602CBM
        • Hospital Privado de Comunidad. ( Site 0130)
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Hospital Universitario Austral ( Site 0127)
    • Caba
      • Ciudad de Buenos Aires, Caba, Argentina, C1093AAS
        • Fundacion Favaloro ( Site 0128)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CVB
        • Sanatorio Britanico ( Site 0125)
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Sanatorio Parque ( Site 0135)
      • Rosario, Santa Fe, Argentina, S2002KDS
        • Hospital Provincial del Centenario ( Site 0131)
  • Australia
    • New South Wales
      • Orange, New South Wales, Australia, 2800
        • Orange Health Services ( Site 0624)
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital ( Site 0621)
  • Belgium
    • Antwerpen
      • Mechelen, Antwerpen, Belgium, 2800
        • AZ Sint-Maarten ( Site 0226)
    • Liege
      • Liège, Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 0224)
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • AZ Nikolaas ( Site 0225)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven ( Site 0221)
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ Delta ( Site 0222)
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)
      • Sao Paulo, Brazil, 01321-001
        • Hospital Paulistano - Amil Clinical Research ( Site 0822)
      • Sao Paulo, Brazil, 01327-001
        • Hospital Alemao Oswaldo Cruz ( Site 0158)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60336-232
        • Centro Regional Integrado de Oncologia ( Site 0160)
      • Fortaleza, Ceara, Brazil, 60430-230
        • Instituto do Cancer do Ceara ( Site 0152)
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70200-730
        • Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra o Cancer ( Site 0150)
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700 000
        • Hospital de Caridade de Ijui ( Site 0153)
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao ( Site 0145)
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil, 88020-210
        • YNOVA Pesquisa Clinica ( Site 0823)
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 0109)
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)
      • Montreal, Quebec, Canada, H3T 1M5
        • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 0111)
  • China
    • Anhui
      • Tianjin, Anhui, China, 300052
        • Tianjin Medical University General Hospital ( Site 0806)
    • Beijing
      • Beijing, Beijing, China, 100010
        • Beijing Cancer Hospital ( Site 0810)
      • Beijing, Beijing, China, 100010
        • Beijing Cancer Hospital ( Site 0811)
      • Beijing, Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital ( Site 0812)
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital ( Site 0809)
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center ( Site 0816)
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital ( Site 0815)
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center ( Site 0813)
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital of Fudan University ( Site 0808)
      • Shanghai, Shanghai, China, 200433
        • Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)
    • Shanxi
      • XI An, Shanxi, China, 710038
        • Tang Du Hospital ( Site 0803)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital of Zhejiang University ( Site 0804)
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital.... ( Site 0814)
      • Ningbo, Zhejiang, China, 315010
        • Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)
  • Estonia
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 13419
        • SA Pohja-Eesti Regionaalhaigla ( Site 1100)
  • France
      • Paris, France, 75248
        • Institut Curie ( Site 0250)
    • Ain
      • Suresnes, Ain, France, 92150
        • Hopital Foch ( Site 0243)
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67091
        • Nouvel Hopital Civil ( Site 0255)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31100
        • CHU de Toulouse - Hopital Larrey ( Site 0258)
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87039
        • Clinique Francois Chenieux ( Site 0246)
    • Rhone-Alpes
      • Pierre-Benite, Rhone-Alpes, France, 69310
        • Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)
    • Savoie
      • Chambery, Savoie, France, 73011
        • Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)
      • Pringy, Savoie, France, 74374
        • Centre Hospitalier Annecy Genevois ( Site 0242)
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76031
        • CHU de Rouen ( Site 0252)
    • Seine-Saint-Denis
      • Bobigny, Seine-Saint-Denis, France, 93000
        • Hôpital Avicenne - Service d oncologie medicale ( Site 0249)
    • Var
      • Toulon, Var, France, 83800
        • H.I.A. Sainte-Anne ( Site 0251)
  • Germany
      • Berlin, Germany, 13125
        • Evangelische Lungenklinik Berlin ( Site 0274)
      • Berlin, Germany, 14165
        • HELIOS Klinikum Emil von Behring ( Site 0280)
      • Hamburg, Germany, 21075
        • Asklepios Klinikum Hamburg ( Site 0271)
    • Baden-Wurttemberg
      • Esslingen, Baden-Wurttemberg, Germany, 73730
        • Klinikum Esslingen GmbH ( Site 0875)
    • Hessen
      • Immenhausen, Hessen, Germany, 34376
        • LKI Lungenfachklinik Immenhausen ( Site 0268)
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, Germany, 40489
        • Florence Nightingale Krankenhaus ( Site 0874)
      • Hemer, Nordrhein-Westfalen, Germany, 58675
        • Lungenklinik Hemer ( Site 0269)
      • Rheine, Nordrhein-Westfalen, Germany, 48431
        • Mathias Spital Rheine ( Site 0261)
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56073
        • Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus ( Site 0273)
      • Leipzig, Sachsen, Germany, 04103
        • Universitaetsklinikum Leipzig AOeR ( Site 0277)
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Germany, 22927
        • LungenClinic Grosshansdorf GmbH ( Site 0267)
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig Holstein ( Site 0871)
    • Thuringen
      • Bad Berka, Thuringen, Germany, 99437
        • Zentralklinik Bad Berka GmbH ( Site 0264)
      • Gera, Thuringen, Germany, 07548
        • SRH Waldklinikum Gera GmbH ( Site 0272)
  • Ireland
      • Dublin, Ireland, D08 K0Y5
        • St James Hospital ( Site 0451)
      • Limerick, Ireland, V98F858
        • Mid Western Cancer Centre ( Site 0450)
    • Cork
      • Wilton, Cork, Ireland
        • Cork University Hospital ( Site 0452)
  • Italy
      • Brescia, Italy, 25123
        • Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele di Milano ( Site 0303)
      • Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini ( Site 0311)
    • Abruzzo
      • Milano, Abruzzo, Italy, 20133
        • Istituto Nazionale Tumori ( Site 0309)
    • Campania
      • Napoli, Campania, Italy, 80131
        • Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)
    • Lombardia
      • Rozzano, Lombardia, Italy, 20089
        • Istituto Clinico Humanitas Research Hospital ( Site 0314)
    • Milano
      • Milan, Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)
    • Monza E Brianza
      • Monza, Monza E Brianza, Italy, 20900
        • Azienda Ospedaliera San Gerardo ( Site 0308)
    • Torino
      • Orbassano, Torino, Italy, 10043
        • AOU San Luigi Gonzaga di Orbassano ( Site 0313)
  • Japan
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital ( Site 0772)
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital ( Site 0762)
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 0767)
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital ( Site 0768)
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital ( Site 0771)
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital ( Site 0765)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 0761)
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Hyogo Cancer Center ( Site 0764)
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital ( Site 0769)
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center ( Site 0763)
    • Oita
      • Yufu, Oita, Japan, 879-5593
        • Oita University Hospital ( Site 0766)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 0701)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 0704)
      • Seoul, Korea, Republic of, 07071
        • SMG-SNU Boramae Medical Center ( Site 0707)
    • Kyonggi-do
      • Gyeonggi-do, Kyonggi-do, Korea, Republic of, 10408
        • National Cancer Center ( Site 0702)
      • Gyeonggi-do, Kyonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea St. Vincent s Hospital ( Site 0705)
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital ( Site 0911)
      • Riga, Latvia, 1079
        • Riga East Clinical University Hospital ( Site 0912)
  • Lithuania
      • Kaunas, Lithuania, 50161
        • LSMUL Kauno Klinikos ( Site 0932)
      • Vilnius, Lithuania, 08406
        • Nacionalinis Vezio Institutas ( Site 0931)
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre ( Site 0781)
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital ( Site 0782)
  • Poland
    • Dolnoslaskie
      • Bystra, Dolnoslaskie, Poland, 43-360
        • Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)
      • Wroclaw, Dolnoslaskie, Poland, 53-413
        • Dolnoslaskie Centrum Onkologii. ( Site 0491)
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-513
        • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)
    • Pomorskie
      • Prabuty, Pomorskie, Poland, 82-550
        • Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)
  • Romania
      • Brasov, Romania, 500091
        • Spitalul Sf. Constantin ( Site 0512)
      • Bucuresti, Romania, 014461
        • Euroclinic Hospital Bucharest ( Site 0510)
      • Bucuresti, Romania, 021389
        • S.C.Focus Lab Plus S.R.L ( Site 0513)
      • Constanta, Romania, 900591
        • Spitalul clinic Judetean de urgenta Constanta ( Site 0508)
      • Suceava, Romania, 720237
        • Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)
    • Bihor
      • Oradea, Bihor, Romania, 410450
        • S C Pelican Impex SRL ( Site 0506)
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 010626
        • Centrul Medical Medicover Victoria ( Site 0514)
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)
      • Comuna Floresti, Cluj, Romania, 407280
        • SC Radiotherapy Center Cluj SRL ( Site 0509)
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)
    • Ilfov
      • Otopeni, Ilfov, Romania, 075100
        • S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)
    • Timis
      • Timisoara, Timis, Romania, 300166
        • S C Oncocenter Oncologie Medicala S R L ( Site 0505)
  • Russian Federation
    • Chelyabinskaya Oblast
      • Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • N.N. Blokhin NMRCO ( Site 0521)
      • Moscow, Moskva, Russian Federation, 125284
        • National Medical Research Radiology Centre ( Site 0535)
      • Moscow, Moskva, Russian Federation, 125367
        • Medical Rehabilitation Center ( Site 0534)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194291
        • SBHI Leningrad Regional Clinical Hospital ( Site 0524)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 198255
        • Municipal Clinical Oncology Center ( Site 0523)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)
    • Tomskaya Oblast
      • Tomsk, Tomskaya Oblast, Russian Federation, 634028
        • Tomsk Scientific Research Institute of Oncology ( Site 0526)
  • South Africa
    • Gauteng
      • Parktown-Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research ( Site 0570)
      • Pretoria, Gauteng, South Africa, 0081
        • Wilgers Oncology Centre ( Site 0573)
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4001
        • The Oncology Centre ( Site 0571)
    • Western Cape
      • Kraaifontein, Western Cape, South Africa, 7570
        • Cape Town Oncology Trials Pty Ltd ( Site 0572)
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau ( Site 0385)
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d Hebron ( Site 0389)
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Maranon ( Site 0382)
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocio ( Site 0387)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)
      • L Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Instituto Catalan de Oncologia - ICO ( Site 0388)
    • La Coruna
      • Girona, La Coruna, Spain, 17007
        • Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35001
        • Hospital Universitario Insular de Gran Canaria ( Site 0383)
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital ( Site 0725)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 0724)
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital ( Site 0721)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 0722)
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital ( Site 0726)
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation.Linkou Branch ( Site 0723)
  • Ukraine
    • Cherkaska Oblast
      • Cherkasy, Cherkaska Oblast, Ukraine, 18009
        • Cherkassy Regional Oncological Center ( Site 0613)
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
        • City Clinical Hosp.4 of DCC ( Site 0607)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
        • MI Precarpathian Clinical Oncology Center ( Site 0603)
    • Khersonska Oblast
      • Kherson, Khersonska Oblast, Ukraine, 73000
        • MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)
    • Kirovohradska Oblast
      • Kropyvnytsky, Kirovohradska Oblast, Ukraine, 25006
        • PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03022
        • National Cancer Institute of the MoH of Ukraine ( Site 0605)
      • Kyiv, Kyivska Oblast, Ukraine, 03115
        • Kyiv City Clinical Oncological Center ( Site 0601)
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65055
        • MI Odessa Regional Oncological Centre ( Site 0608)
    • Zaporizka Oblast
      • Zaporizhzhya, Zaporizka Oblast, Ukraine, 69040
        • Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital in Birmingham ( Site 0455)
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital ( Site 0444)
      • Plymouth, United Kingdom, PL6 8DH
        • Plymouth Hospitals NHS Trust ( Site 0443)
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary ( Site 0447)
    • Liverpool
      • Wirral, Liverpool, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)
    • London, City Of
      • London, London, City Of, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Foundation Trust ( Site 0458)
      • Sutton, London, City Of, United Kingdom, SM2 5PT
        • Royal Marsden Hospital ( Site 0457)
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham City Hospital Campus ( Site 0441)
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center ( Site 0028)
      • Goodyear, Arizona, United States, 85338
        • Western Regional Medical Center, Inc. ( Site 0050)
      • Phoenix, Arizona, United States, 85004
        • University of Arizona Cancer Center - Dignity Health ( Site 0062)
      • Tucson, Arizona, United States, 85724
        • University of Arizona Cancer Center ( Site 0012)
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc. ( Site 0004)
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center ( Site 0061)
      • Monterey, California, United States, 93940
        • Pacific Cancer Care ( Site 0035)
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute ( Site 0049)
      • Santa Rosa, California, United States, 95403
        • St Joseph Heritage Healthcare ( Site 0040)
      • Stanford, California, United States, 94305
        • Stanford University, Stanford Cancer Center ( Site 0046)
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital ( Site 0069)
    • Delaware
      • Newark, Delaware, United States, 19718
        • Helen F. Graham Cancer Center & Research Institute ( Site 0015)
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville ( Site 0022)
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute-Baptist Hospital ( Site 0068)
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Southeastern Regional Medical Center ( Site 0051)
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Northwest Oncology and Hematology ( Site 0001)
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital ( Site 0044)
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • PPG-Oncology ( Site 0043)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics ( Site 0010)
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Ashland-Bellefonte Cancer Center ( Site 0021)
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Harry & Jeanette Weinberg Cancer Institute ( Site 0081)
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center ( Site 0057)
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center ( Site 0030)
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System ( Site 0031)
      • Lansing, Michigan, United States, 48912
        • Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic ( Site 0026)
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Healthcare Frontier Cancer Center ( Site 0005)
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • University of Nebraska Medical Center ( Site 0047)
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)
      • Montvale, New Jersey, United States, 07645
        • MSKCC-Bergen ( Site 0075)
    • New York
      • Albany, New York, United States, 12208
        • St. Peter's Hospital Cancer Care Center ( Site 0039)
      • Bronx, New York, United States, 10461
        • Montefiore Einstein Center ( Site 0016)
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center ( Site 0060)
      • Stony Brook, New York, United States, 11794-9447
        • Stony Brook University Medical Center - Cancer Center ( Site 0019)
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)
      • White Plains, New York, United States, 10601
        • White Plains Hospital Center for Cancer Care ( Site 0007)
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Southwestern Regional Medical Center, Inc. ( Site 0054)
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Center for Health & Healing ( Site 1006)
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17109
        • UPMC Pinnacle Health System - East Location ( Site 0063)
      • Philadelphia, Pennsylvania, United States, 19124
        • Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital ( Site 0009)
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Centers ( Site 0041)
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System ( Site 0052)
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Cancer Center ( Site 0096)
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Emily Couric Clinical Cancer Center ( Site 0013)
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute ( Site 0032)
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC ( Site 0080)
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership ( Site 0065)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC.
  • If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention.
  • If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
  • Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization.
  • Have adequate organ function.

Exclusion Criteria:

  • Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.
  • Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
  • Has an active infection requiring systemic therapy.
  • Has had an allogenic tissue/sold organ transplant.
  • Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients.
  • Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of Hepatitis B or Hepatitis C.
  • Has a known history of active tuberculosis.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.
  • Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
  • Has received prior radiotherapy within 2 weeks of start of trial treatment.
  • Has received a live vaccine within 30 days prior to the first dose of trial drug.
  • Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
  • Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
  • Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAC + Neoadjuvant/Adjuvant Pembrolizumab

Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1].

Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].
Biological: Pembrolizumab
200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Cisplatin
75 mg/m^2 by IV infusion Q3W, given on cycle day 1.
Other Names:
  • PLATINOL®
Drug: Gemcitabine
1000 mg/m^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.
Other Names:
  • GEMZAR®
Drug: Pemetrexed
500 mg/m^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.
Other Names:
  • Alimta®
Placebo Comparator: NAC + Neoadjuvant/Adjuvant Placebo

Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1].

Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].
Drug: Cisplatin
75 mg/m^2 by IV infusion Q3W, given on cycle day 1.
Other Names:
  • PLATINOL®
Drug: Gemcitabine
1000 mg/m^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.
Other Names:
  • GEMZAR®
Drug: Pemetrexed
500 mg/m^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.
Other Names:
  • Alimta®
Drug: Placebo
Normal saline by IV infusion Q3W, given on cycle day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival (EFS)
Time Frame: Up to approximately 5 years
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The EFS for all participants is presented (through database cut-off date of 10-Jul-2023).
Up to approximately 5 years
Overall Survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as the time from randomization until death from any cause. The OS for all participants is presented (through database cut-off date of 10-Jul-2023).
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Pathological Response (mPR) Rate
Time Frame: Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. The mPR rates as assessed by blinded independent pathologist are presented.
Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
Pathological Complete Response (pCR) Rate
Time Frame: Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. The pCR rates as assessed by blinded independent pathologist are presented.
Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
Change From Baseline in Neoadjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score
Time Frame: Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11
Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.
Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11
Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score
Time Frame: Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)
Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.
Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 71 weeks
Up to approximately 71 weeks
Number of Participants Who Experience Perioperative Complications
Time Frame: Up to approximately 51 weeks following surgery
Perioperative complications are a discrete set of both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy. The number of participants experiencing perioperative complications will be assessed.
Up to approximately 51 weeks following surgery
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Time Frame: Up to approximately 57 weeks
Up to approximately 57 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

July 10, 2023

Study Completion (Estimated)

June 29, 2026

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-671
  • MK-3475-671 (Other Identifier: MSD)
  • 183970 (Other Identifier: JAPIC-CTI)
  • 2017-001832-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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