Non-small Cell Lung CancerPhase 3NCT03425643
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)
A Phase 3 study testing Pembrolizumab, Cisplatin and Gemcitabine in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 227 sites in 25 countries.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Pembrolizumab, Cisplatin and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 797 participants
- Where
- 227 sitesin 25 countries
- Study dates
- 24 Apr 2018to 15 Oct 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
227 sites in 25 countries.
227 sites in 25 countries
United States51 sites
St. Peter's Hospital Cancer Care Center ( Site 0039)
Albany, New York, 12208
Pacific Cancer Medical Center, Inc. ( Site 0004)
Anaheim, California, 92801
Ashland-Bellefonte Cancer Center ( Site 0021)
Ashland, Kentucky, 41101
Harry & Jeanette Weinberg Cancer Institute ( Site 0081)
Baltimore, Maryland, 21237
Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)
Basking Ridge, New Jersey, 07920
St. Vincent Healthcare Frontier Cancer Center ( Site 0005)
Billings, Montana, 59102
Boston Medical Center ( Site 0057)
Boston, Massachusetts, 02118
Providence Saint Joseph Medical Center ( Site 0061)
Burbank, California, 91505
Emily Couric Clinical Cancer Center ( Site 0013)
Charlottesville, Virginia, 22903
Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)
Commack, New York, 11725
Henry Ford Health System ( Site 0031)
Detroit, Michigan, 48202
Northwest Oncology and Hematology ( Site 0001)
Elk Grove Village, Illinois, 60007
Providence Regional Cancer Partnership ( Site 0065)
Everett, Washington, 98201
Inova Schar Cancer Institute ( Site 0032)
Fairfax, Virginia, 22031
Virginia Cancer Specialists, PC ( Site 0080)
Fairfax, Virginia, 22031
PPG-Oncology ( Site 0043)
Fort Wayne, Indiana, 46845
Banner MD Anderson Cancer Center ( Site 0028)
Gilbert, Arizona, 85234
Western Regional Medical Center, Inc. ( Site 0050)
Goodyear, Arizona, 85338
Saint Francis Cancer Center ( Site 0096)
Greenville, South Carolina, 29607
UPMC Pinnacle Health System - East Location ( Site 0063)
Harrisburg, Pennsylvania, 17109
Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)
Harrison, New York, 10604
Hartford Hospital ( Site 0069)
Hartford, Connecticut, 06102
Ingalls Memorial Hospital ( Site 0044)
Harvey, Illinois, 60426
University of Iowa Hospital and Clinics ( Site 0010)
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville ( Site 0022)
Jacksonville, Florida, 32224
Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)
Lansing, Michigan, 48912
Miami Cancer Institute-Baptist Hospital ( Site 0068)
Miami, Florida, 33176
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)
Middletown, New Jersey, 07748
Pacific Cancer Care ( Site 0035)
Monterey, California, 93940
MSKCC-Bergen ( Site 0075)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center ( Site 0060)
New York, New York, 10065
Helen F. Graham Cancer Center & Research Institute ( Site 0015)
Newark, Delaware, 19718
Southeastern Regional Medical Center ( Site 0051)
Newnan, Georgia, 30265
University of Nebraska Medical Center ( Site 0047)
Omaha, Nebraska, 68198-7680
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)
Philadelphia, Pennsylvania, 19124
University of Arizona Cancer Center - Dignity Health ( Site 0062)
Phoenix, Arizona, 85004
Allegheny General Hospital ( Site 0009)
Pittsburgh, Pennsylvania, 15212
UPMC Hillman Cancer Centers ( Site 0041)
Pittsburgh, Pennsylvania, 15232
VA Pittsburgh Healthcare System ( Site 0052)
Pittsburgh, Pennsylvania, 15240
OHSU Center for Health & Healing ( Site 1006)
Portland, Oregon, 97239
Mayo Clinic ( Site 0026)
Rochester, Minnesota, 55905
John Wayne Cancer Institute ( Site 0049)
Santa Monica, California, 90404
St Joseph Heritage Healthcare ( Site 0040)
Santa Rosa, California, 95403
Stanford University, Stanford Cancer Center ( Site 0046)
Stanford, California, 94305
Stony Brook University Medical Center - Cancer Center ( Site 0019)
Stony Brook, New York, 11794-9447
Montefiore Einstein Center ( Site 0016)
The Bronx, New York, 10461
University of Arizona Cancer Center ( Site 0012)
Tucson, Arizona, 85724
Southwestern Regional Medical Center, Inc. ( Site 0054)
Tulsa, Oklahoma, 74133
Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)
Uniondale, New York, 11553
White Plains Hospital Center for Cancer Care ( Site 0007)
White Plains, New York, 10601
UMass Memorial Medical Center ( Site 0030)
Worcester, Massachusetts, 01655
China15 sites
Beijing Cancer Hospital ( Site 0810)
Beijing, Beijing Municipality, 100010
Beijing Cancer Hospital ( Site 0811)
Beijing, Beijing Municipality, 100010
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)
Beijing, Beijing Municipality, 100021
Peking University Third Hospital ( Site 0812)
Beijing, Beijing Municipality, 100191
Peking Union Medical College Hospital ( Site 0809)
Beijing, Beijing Municipality, 100730
Hunan Cancer Hospital ( Site 0815)
Changsha, Hunan, 410013
Sun Yat-Sen University Cancer Center ( Site 0816)
Guangzhou, Guangdong, 510060
The First Affiliated Hospital of Zhejiang University ( Site 0804)
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital.... ( Site 0814)
Hangzhou, Zhejiang, 310022
Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)
Ningbo, Zhejiang, 315010
Fudan University Shanghai Cancer Center ( Site 0813)
Shanghai, Shanghai Municipality, 200032
Zhongshan Hospital of Fudan University ( Site 0808)
Shanghai, Shanghai Municipality, 200032
Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)
Shanghai, Shanghai Municipality, 200433
Tianjin Medical University General Hospital ( Site 0806)
Tianjin, Anhui, 300052
Tang Du Hospital ( Site 0803)
Xi’an, Shanxi, 710038
Germany15 sites
Zentralklinik Bad Berka GmbH ( Site 0264)
Bad Berka, Thuringia, 99437
Evangelische Lungenklinik Berlin ( Site 0274)
Berlin, 13125
HELIOS Klinikum Emil von Behring ( Site 0280)
Berlin, 14165
Universitaetsklinikum Carl Gustav Carus ( Site 0273)
Dresden, Saxony, 01307
Florence Nightingale Krankenhaus ( Site 0874)
Düsseldorf, North Rhine-Westphalia, 40489
Klinikum Esslingen GmbH ( Site 0875)
Esslingen am Neckar, Baden-Wurttemberg, 73730
SRH Waldklinikum Gera GmbH ( Site 0272)
Gera, Thuringia, 07548
LungenClinic Grosshansdorf GmbH ( Site 0267)
Großhansdorf, Schleswig-Holstein, 22927
Asklepios Klinikum Hamburg ( Site 0271)
Hamburg, 21075
Lungenklinik Hemer ( Site 0269)
Hemer, North Rhine-Westphalia, 58675
LKI Lungenfachklinik Immenhausen ( Site 0268)
Immenhausen, Hesse, 34376
Universitaetsklinikum Schleswig Holstein ( Site 0871)
Kiel, Schleswig-Holstein, 24105
Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)
Koblenz, Rhineland-Palatinate, 56073
Universitaetsklinikum Leipzig AOeR ( Site 0277)
Leipzig, Saxony, 04103
Mathias Spital Rheine ( Site 0261)
Rheine, North Rhine-Westphalia, 48431
Romania13 sites
Spitalul Sf. Constantin ( Site 0512)
Brasov, 500091
Centrul Medical Medicover Victoria ( Site 0514)
Bucharest, Bucharest, 010626
Euroclinic Hospital Bucharest ( Site 0510)
Bucharest, 014461
S.C.Focus Lab Plus S.R.L ( Site 0513)
Bucharest, 021389
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)
Cluj-Napoca, Cluj, 400015
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)
Cluj-Napoca, Cluj, 400015
SC Radiotherapy Center Cluj SRL ( Site 0509)
Comuna Floresti, Cluj, 407280
Spitalul clinic Judetean de urgenta Constanta ( Site 0508)
Constanța, 900591
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)
Craiova, Dolj, 200347
S C Pelican Impex SRL ( Site 0506)
Oradea, Bihor County, 410450
S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)
Otopeni, Ilfov, 075100
Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)
Suceava, 720237
S C Oncocenter Oncologie Medicala S R L ( Site 0505)
Timișoara, Timiș County, 300166
Brazil12 sites
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)
Barretos, São Paulo, 14784-400
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)
Brasília, Federal District, 70200-730
YNOVA Pesquisa Clinica ( Site 0823)
Florianópolis, Santa Catarina, 88020-210
Centro Regional Integrado de Oncologia ( Site 0160)
Fortaleza, Ceará, 60336-232
Instituto do Cancer do Ceara ( Site 0152)
Fortaleza, Ceará, 60430-230
Hospital de Caridade de Ijui ( Site 0153)
Ijuí, Rio Grande do Sul, 98700 000
Liga Norte Riograndense Contra o Cancer ( Site 0150)
Natal, Rio Grande do Norte, 59075-740
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital Nossa Senhora da Conceicao ( Site 0145)
Porto Alegre, Rio Grande do Sul, 91350-200
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)
Rio de Janeiro, 20230-130
Hospital Paulistano - Amil Clinical Research ( Site 0822)
São Paulo, 01321-001
Hospital Alemao Oswaldo Cruz ( Site 0158)
São Paulo, 01327-001
Japan12 sites
Hyogo Cancer Center ( Site 0764)
Akashi, Hyōgo, 673-8558
Fukushima Medical University Hospital ( Site 0772)
Fukushima, 960-1295
Hiroshima University Hospital ( Site 0762)
Hiroshima, 734-8551
National Cancer Center Hospital East ( Site 0761)
Kashiwa, Chiba, 277-8577
St. Marianna University School of Medicine Hospital ( Site 0769)
Kawasaki, Kanagawa, 216-8511
HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)
Kitakyushu, Fukuoka, 807-8556
Aichi Cancer Center Hospital ( Site 0765)
Nagoya, Aichi-ken, 464-8681
National Cancer Center Hospital ( Site 0767)
Tokyo, 104-0045
Juntendo University Hospital ( Site 0768)
Tokyo, 113-8431
Tokyo Medical University Hospital ( Site 0771)
Tokyo, 160-0023
Kanagawa Cancer Center ( Site 0763)
Yokohama, Kanagawa, 241-8515
Oita University Hospital ( Site 0766)
Yufu, Oita Prefecture, 879-5593
France11 sites
Hôpital Avicenne - Service d oncologie medicale ( Site 0249)
Bobigny, Seine-Saint-Denis, 93000
Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)
Chambéry, Savoie, 73011
Clinique Francois Chenieux ( Site 0246)
Limoges, Haute-Vienne, 87039
Institut Curie ( Site 0250)
Paris, 75248
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310
Centre Hospitalier Annecy Genevois ( Site 0242)
Pringy, Savoie, 74374
CHU de Rouen ( Site 0252)
Rouen, Seine-Maritime, 76031
Nouvel Hopital Civil ( Site 0255)
Strasbourg, Bas-Rhin, 67091
Hopital Foch ( Site 0243)
Suresnes, Ain, 92150
H.I.A. Sainte-Anne ( Site 0251)
Toulon, Var, 83800
CHU de Toulouse - Hopital Larrey ( Site 0258)
Toulouse, Haute-Garonne, 31100
Argentina10 sites
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
Berazategui, Buenos Aires, B1884BBF
Fundacion Favaloro ( Site 0128)
Ciudad de Buenos Aires, Buenos Aires F.D., C1093AAS
Hospital Privado Universitario de Córdoba ( Site 0139)
Córdoba, 5016
Sanatorio Allende ( Site 0129)
Córdoba, X5000JHQ
Hospital Privado de Comunidad. ( Site 0130)
Mar del Plata, Buenos Aires, B7602CBM
Hospital Universitario Austral ( Site 0127)
Pilar, Buenos Aires, B1629ODT
Sanatorio Britanico ( Site 0125)
Rosario, Santa Fe Province, S2000CVB
Sanatorio Parque ( Site 0135)
Rosario, Santa Fe Province, S2000DSV
Hospital Provincial del Centenario ( Site 0131)
Rosario, Santa Fe Province, S2002KDS
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)
San Juan, J5402DIL
Italy10 sites
Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)
Brescia, 25123
IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)
Meldola, Forli-Cesena, 47014
ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)
Milan, Milano, 20162
IRCCS Ospedale San Raffaele di Milano ( Site 0303)
Milan, 20132
Istituto Nazionale Tumori ( Site 0309)
Milano, Abruzzo, 20133
Azienda Ospedaliera San Gerardo ( Site 0308)
Monza, Monza E Brianza, 20900
Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)
Naples, Campania, 80131
AOU San Luigi Gonzaga di Orbassano ( Site 0313)
Orbassano, Torino, 10043
Azienda Ospedaliera San Camillo Forlanini ( Site 0311)
Roma, 00152
Istituto Clinico Humanitas Research Hospital ( Site 0314)
Rozzano, Lombardy, 20089
Russia9 sites
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)
Chelyabinsk, Chelyabinsk Oblast, 454087
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)
Kazan', Tatarstan, Respublika, 420029
N.N. Blokhin NMRCO ( Site 0521)
Moscow, Moscow, 115478
National Medical Research Radiology Centre ( Site 0535)
Moscow, Moscow, 125284
Medical Rehabilitation Center ( Site 0534)
Moscow, Moscow, 125367
SBHI Leningrad Regional Clinical Hospital ( Site 0524)
Saint Petersburg, Sankt-Peterburg, 194291
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)
Saint Petersburg, Sankt-Peterburg, 197758
Municipal Clinical Oncology Center ( Site 0523)
Saint Petersburg, Sankt-Peterburg, 198255
Tomsk Scientific Research Institute of Oncology ( Site 0526)
Tomsk, Tomsk Oblast, 634028
Ukraine9 sites
Cherkassy Regional Oncological Center ( Site 0613)
Cherkasy, Cherkasy Oblast, 18009
City Clinical Hosp.4 of DCC ( Site 0607)
Dnipro, Dnipropetrovsk Oblast, 49102
MI Precarpathian Clinical Oncology Center ( Site 0603)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)
Kherson, Kherson Oblast, 73000
PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)
Kropyvnytsky, Kirovohrad Oblast, 25006
National Cancer Institute of the MoH of Ukraine ( Site 0605)
Kyiv, Kyivska Oblast, 03022
Kyiv City Clinical Oncological Center ( Site 0601)
Kyiv, Kyivska Oblast, 03115
MI Odessa Regional Oncological Centre ( Site 0608)
Odesa, Odesa Oblast, 65055
Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)
Zaporizhzhya, Zaporizhzhia Oblast, 69040
Spain8 sites
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau ( Site 0385)
Barcelona, 08025
Hospital Universitari Vall d Hebron ( Site 0389)
Barcelona, 08035
Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)
Girona, La Coruna, 17007
Instituto Catalan de Oncologia - ICO ( Site 0388)
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Insular de Gran Canaria ( Site 0383)
Las Palmas de Gran Canaria, Las Palmas, 35001
Hospital General Universitario Gregorio Maranon ( Site 0382)
Madrid, 28009
Hospital Virgen del Rocio ( Site 0387)
Seville, 41013
United Kingdom8 sites
Heartlands Hospital in Birmingham ( Site 0455)
Birmingham, B9 5SS
Leicester Royal Infirmary ( Site 0447)
Leicester, Leicestershire, LE1 5WW
Royal Marsden NHS Foundation Trust ( Site 0458)
London, London, City of, SW3 6JJ
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)
Metropolitan Borough of Wirral, Liverpool, CH63 4JY
Freeman Hospital ( Site 0444)
Newcastle upon Tyne, NE7 7DN
Nottingham City Hospital Campus ( Site 0441)
Nottingham, Nottinghamshire, NG5 1PB
Plymouth Hospitals NHS Trust ( Site 0443)
Plymouth, PL6 8DH
Royal Marsden Hospital ( Site 0457)
Sutton, London, City of, SM2 5PT
Belgium6 sites
UZ Gent ( Site 0224)
Ghent, Oost-Vlaanderen, 9000
UZ Leuven ( Site 0221)
Leuven, Vlaams-Brabant, 3000
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)
Liège, Liege, 4000
AZ Sint-Maarten ( Site 0226)
Mechelen, Antwerpen, 2800
AZ Delta ( Site 0222)
Roeselare, West-Vlaanderen, 8800
AZ Nikolaas ( Site 0225)
Sint-Niklaas, Oost-Vlaanderen, 9100
Poland6 sites
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)
Bystra, Lower Silesian Voivodeship, 43-360
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)
Lodz, Łódź Voivodeship, 93-513
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)
Poznan, Greater Poland Voivodeship, 60-569
Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)
Prabuty, Pomeranian Voivodeship, 82-550
Dolnoslaskie Centrum Onkologii. ( Site 0491)
Wroclaw, Lower Silesian Voivodeship, 53-413
Taiwan6 sites
Kaohsiung Chang Gung Memorial Hospital ( Site 0725)
Kaohsiung City, 83301
China Medical University Hospital ( Site 0724)
Taichung, 40447
National Taiwan University Hospital ( Site 0721)
Taipei, 10048
Taipei Veterans General Hospital ( Site 0722)
Taipei, 112
Tri-Service General Hospital ( Site 0726)
Taipei, 114
Chang Gung Medical Foundation.Linkou Branch ( Site 0723)
Taoyuan, 333
Canada5 sites
CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)
Chicoutimi, Quebec, G7H 5H6
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)
Montreal, Quebec, H2X 0C1
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)
Montreal, Quebec, H3T 1M5
McGill University Health Centre ( Site 0111)
Montreal, Quebec, H4A 3J1
Princess Margaret Cancer Centre ( Site 0109)
Toronto, Ontario, M5G 2M9
South Korea5 sites
National Cancer Center ( Site 0702)
Gyeonggi-do, Kyonggi-do, 10408
The Catholic University of Korea St. Vincent s Hospital ( Site 0705)
Gyeonggi-do, Kyonggi-do, 16247
Asan Medical Center ( Site 0701)
Seoul, 05505
Samsung Medical Center ( Site 0704)
Seoul, 06351
SMG-SNU Boramae Medical Center ( Site 0707)
Seoul, 07071
South Africa4 sites
The Oncology Centre ( Site 0571)
Durban, KwaZulu-Natal, 4001
Cape Town Oncology Trials Pty Ltd ( Site 0572)
Kraaifontein, Western Cape, 7570
Wits Clinical Research ( Site 0570)
Parktown-Johannesburg, Gauteng, 2193
Wilgers Oncology Centre ( Site 0573)
Pretoria, Gauteng, 0081
Ireland3 sites
St James Hospital ( Site 0451)
Dublin, D08 K0Y5
Mid Western Cancer Centre ( Site 0450)
Limerick, V98F858
Cork University Hospital ( Site 0452)
Wilton, Cork
Australia2 sites
Orange Health Services ( Site 0624)
Orange, New South Wales, 2800
Westmead Hospital ( Site 0621)
Westmead, New South Wales, 2145
Latvia2 sites
Pauls Stradins Clinical University Hospital ( Site 0911)
Riga, 1002
Riga East Clinical University Hospital ( Site 0912)
Riga, 1079
Lithuania2 sites
LSMUL Kauno Klinikos ( Site 0932)
Kaunas, 50161
Nacionalinis Vezio Institutas ( Site 0931)
Vilnius, 08406
Malaysia2 sites
University Malaya Medical Centre ( Site 0781)
Kuala Lumpur, 59100
Sarawak General Hospital ( Site 0782)
Kuching, Sarawak, 93586
Estonia1 site
SA Pohja-Eesti Regionaalhaigla ( Site 1100)
Tallinn, Harju, 13419
About this study
Official title: 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).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Pembrolizumab, Placebo, Cisplatin, Gemcitabine, Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called KEYTRUDA®, MK-3475
200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
PlaceboDrug
Normal saline by IV infusion Q3W, given on cycle day 1.
CisplatinDrug
Also called PLATINOL®
75 mg/m^2 by IV infusion Q3W, given on cycle day 1.
GemcitabineDrug
Also called GEMZAR®
1000 mg/m^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.
PemetrexedDrug
Also called Alimta®
500 mg/m^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.
| Study group | Role | What they receive |
|---|---|---|
| NAC + Neoadjuvant/Adjuvant Pembrolizumab | Experimental | 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]. Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed |
| NAC + Neoadjuvant/Adjuvant Placebo | Placebo comparator | 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]. Receives: Drug: Placebo; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival (EFS)
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).
Measured: Up to approximately 5 years
Overall Survival (OS)
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).
Measured: Up to approximately 5 years
Secondary outcomes (7)
Major Pathological Response (mPR) Rate
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.
Measured: Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
Pathological Complete Response (pCR) Rate
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)
Number of Participants Who Experience an Adverse Event (AE)
Measured: Up to approximately 71 weeks
Number of Participants Who Experience Perioperative Complications
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.
Measured: Up to approximately 51 weeks following surgery
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Measured: Up to approximately 57 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start24 Apr 2018
- Primary completion10 Jul 2023
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425643
- Sponsor's protocol ID
- 3475-671
- Other IDs
- MK-3475-671, 183970, 2023-504820-24-00, U1111-1289-8426, 2017-001832-21, 2017, 2023
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2018
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Spicer JD, Garassino MC, Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Arunachalam A, Keller SM, Samkari A, Gao S; KEYNOTE-671 Investigators. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Sep 28;404(10459):1240-1252. doi: 10.1016/S0140-6736(24)01756-2. Epub 2024 Sep 14.
PubMed 39288781Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3.
PubMed 37272513Tsuboi M, Saji H, Okada M, Ikeda N, Takamochi K, Sugio K, Horio Y, Tanaka F, Nishio W, Muto S, Horinouchi H, Wakelee H, Han S, Mori T, Keller SM, Kato T. Perioperative Pembrolizumab in Japanese Participants With Early-Stage NSCLC: Subgroup Analysis From KEYNOTE-671. JTO Clin Res Rep. 2026 May 2;7(10):101009. doi: 10.1016/j.jtocrr.2026.101009. eCollection 2026 Oct.
PubMed 42774586Wakelee H, Spicer JD, Gao S, Liberman M, Tsuboi M, Kato T, Chen KN, Dooms C, Majem M, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Halmos B, Jones DR, Chaft JE, Reck M, Jensen E, Keller SM, Samkari A, Garassino MC. Five-Year Outcomes of Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer From the Randomized KEYNOTE-671 Study. Ann Oncol. 2026 Aug 21:S0923-7534(26)01462-6. doi: 10.1016/j.annonc.2026.08.005. Online ahead of print.
PubMed 42628840Tsuboi M, Wakelee H, Garassino MC, Gao S, Luft A, Chen KN, Spicer JD, Zhu Y, Saji H, Okada M, Vanakesa T, Chen H, Zhao G, Ikeda N, Jones DR, Weksler B, Huang CS, Jensen E, Keller SM, Samkari A, Liberman M. A Subgroup Analysis of Perioperative Pembrolizumab in Clinical Stage II Non-Small-Cell Lung Cancer from the Randomized KEYNOTE-671 Study. Eur J Cardiothorac Surg. 2026 Mar 10;68(3):ezag028. doi: 10.1093/ejcts/ezag028.
PubMed 41875364Aredo JV, Wakelee HA. Top advances of the year: Perioperative therapy for lung cancer. Cancer. 2024 Sep 1;130(17):2897-2903. doi: 10.1002/cncr.35357. Epub 2024 May 8.
PubMed 38717993Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.
PubMed 33661301