Clinical trial NCT03425643: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 797
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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) 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Event Free Survival (EFS)
timeFrame: Up to approximately 5 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Major Pathological Response (mPR) Rate
timeFrame: Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
measure: Pathological Complete Response (pCR) Rate
timeFrame: Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
measure: 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
timeFrame: Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11
measure: 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
timeFrame: Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 71 weeks
measure: Number of Participants Who Experience Perioperative Complications
timeFrame: Up to approximately 51 weeks following surgery
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 57 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center ( Site 0028)
state: Arizona
city: Goodyear
country: United States
facility: Western Regional Medical Center, Inc. ( Site 0050)
state: Arizona
city: Phoenix
country: United States
facility: University of Arizona Cancer Center - Dignity Health ( Site 0062)
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center ( Site 0012)
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc. ( Site 0004)
state: California
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center ( Site 0061)
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care ( Site 0035)
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute ( Site 0049)
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare ( Site 0040)
state: California
city: Stanford
country: United States
facility: Stanford University, Stanford Cancer Center ( Site 0046)
state: California
city: Hartford
country: United States
facility: Hartford Hospital ( Site 0069)
state: Connecticut
city: Newark
country: United States
facility: Helen F. Graham Cancer Center & Research Institute ( Site 0015)
state: Delaware
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville ( Site 0022)
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute-Baptist Hospital ( Site 0068)
state: Florida
city: Newnan
country: United States
facility: Southeastern Regional Medical Center ( Site 0051)
state: Georgia
city: Elk Grove Village
country: United States
facility: Northwest Oncology and Hematology ( Site 0001)
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital ( Site 0044)
state: Illinois
city: Fort Wayne
country: United States
facility: PPG-Oncology ( Site 0043)
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 0010)
state: Iowa
city: Ashland
country: United States
facility: Ashland-Bellefonte Cancer Center ( Site 0021)
state: Kentucky
city: Baltimore
country: United States
facility: Harry & Jeanette Weinberg Cancer Institute ( Site 0081)
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center ( Site 0057)
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center ( Site 0030)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 0031)
state: Michigan
city: Lansing
country: United States
facility: Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic ( Site 0026)
state: Minnesota
city: Billings
country: United States
facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0005)
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center ( Site 0047)
state: Nebraska
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)
state: New Jersey
city: Montvale
country: United States
facility: MSKCC-Bergen ( Site 0075)
state: New Jersey
city: Albany
country: United States
facility: St. Peter's Hospital Cancer Care Center ( Site 0039)
state: New York
city: Bronx
country: United States
facility: Montefiore Einstein Center ( Site 0016)
state: New York
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0060)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center - Cancer Center ( Site 0019)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)
state: New York
city: White Plains
country: United States
facility: White Plains Hospital Center for Cancer Care ( Site 0007)
state: New York
city: Tulsa
country: United States
facility: Southwestern Regional Medical Center, Inc. ( Site 0054)
state: Oklahoma
city: Portland
country: United States
facility: OHSU Center for Health & Healing ( Site 1006)
state: Oregon
city: Harrisburg
country: United States
facility: UPMC Pinnacle Health System - East Location ( Site 0063)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital ( Site 0009)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Centers ( Site 0041)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System ( Site 0052)
state: Pennsylvania
city: Greenville
country: United States
facility: Saint Francis Cancer Center ( Site 0096)
state: South Carolina
city: Charlottesville
country: United States
facility: Emily Couric Clinical Cancer Center ( Site 0013)
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0032)
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC ( Site 0080)
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership ( Site 0065)
state: Washington
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad. ( Site 0130)
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral ( Site 0127)
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Fundacion Favaloro ( Site 0128)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Britanico ( Site 0125)
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0135)
state: Santa Fe
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 0131)
state: Santa Fe
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario de Córdoba ( Site 0139)
city: Cordoba
country: Argentina
facility: Sanatorio Allende ( Site 0129)
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)
city: Orange
country: Australia
facility: Orange Health Services ( Site 0624)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0621)
state: New South Wales
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten ( Site 0226)
state: Antwerpen
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)
state: Liege
city: Gent
country: Belgium
facility: UZ Gent ( Site 0224)
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas ( Site 0225)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0221)
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta ( Site 0222)
state: West-Vlaanderen
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia ( Site 0160)
state: Ceara
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara ( Site 0152)
state: Ceara
city: Brasilia
country: Brazil
facility: Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)
state: Distrito Federal
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 0150)
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 0153)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 0145)
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: YNOVA Pesquisa Clinica ( Site 0823)
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano - Amil Clinical Research ( Site 0822)
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz ( Site 0158)
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0109)
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0111)
state: Quebec
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital ( Site 0806)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0810)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0811)
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital ( Site 0812)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 0809)
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center ( Site 0816)
state: Guangdong
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0815)
state: Hunan
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 0813)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University ( Site 0808)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)
state: Shanghai
city: XI An
country: China
facility: Tang Du Hospital ( Site 0803)
state: Shanxi
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University ( Site 0804)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital.... ( Site 0814)
state: Zhejiang
city: Ningbo
country: China
facility: Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)
state: Zhejiang
city: Tallinn
country: Estonia
facility: SA Pohja-Eesti Regionaalhaigla ( Site 1100)
state: Harjumaa
city: Suresnes
country: France
facility: Hopital Foch ( Site 0243)
state: Ain
city: Strasbourg
country: France
facility: Nouvel Hopital Civil ( Site 0255)
state: Bas-Rhin
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Larrey ( Site 0258)
state: Haute-Garonne
city: Limoges
country: France
facility: Clinique Francois Chenieux ( Site 0246)
state: Haute-Vienne
city: Pierre-Benite
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)
state: Rhone-Alpes
city: Chambery
country: France
facility: Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)
state: Savoie
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois ( Site 0242)
state: Savoie
city: Rouen
country: France
facility: CHU de Rouen ( Site 0252)
state: Seine-Maritime
city: Bobigny
country: France
facility: Hôpital Avicenne - Service d oncologie medicale ( Site 0249)
state: Seine-Saint-Denis
city: Toulon
country: France
facility: H.I.A. Sainte-Anne ( Site 0251)
state: Var
city: Paris
country: France
facility: Institut Curie ( Site 0250)
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH ( Site 0875)
state: Baden-Wurttemberg
city: Immenhausen
country: Germany
facility: LKI Lungenfachklinik Immenhausen ( Site 0268)
state: Hessen
city: Duesseldorf
country: Germany
facility: Florence Nightingale Krankenhaus ( Site 0874)
state: Nordrhein-Westfalen
city: Hemer
country: Germany
facility: Lungenklinik Hemer ( Site 0269)
state: Nordrhein-Westfalen
city: Rheine
country: Germany
facility: Mathias Spital Rheine ( Site 0261)
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus ( Site 0273)
state: Sachsen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AOeR ( Site 0277)
state: Sachsen
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH ( Site 0267)
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig Holstein ( Site 0871)
state: Schleswig-Holstein
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH ( Site 0264)
state: Thuringen
city: Gera
country: Germany
facility: SRH Waldklinikum Gera GmbH ( Site 0272)
state: Thuringen
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin ( Site 0274)
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring ( Site 0280)
city: Hamburg
country: Germany
facility: Asklepios Klinikum Hamburg ( Site 0271)
city: Wilton
country: Ireland
facility: Cork University Hospital ( Site 0452)
state: Cork
city: Dublin
country: Ireland
facility: St James Hospital ( Site 0451)
city: Limerick
country: Ireland
facility: Mid Western Cancer Centre ( Site 0450)
city: Milano
country: Italy
facility: Istituto Nazionale Tumori ( Site 0309)
state: Abruzzo
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)
state: Campania
city: Meldola
country: Italy
facility: IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)
state: Forli-Cesena
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Research Hospital ( Site 0314)
state: Lombardia
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)
state: Milano
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo ( Site 0308)
state: Monza E Brianza
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga di Orbassano ( Site 0313)
state: Torino
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele di Milano ( Site 0303)
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0311)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0765)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0761)
state: Chiba
city: Kitakyushu
country: Japan
facility: HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)
state: Fukuoka
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 0764)
state: Hyogo
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital ( Site 0769)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0763)
state: Kanagawa
city: Yufu
country: Japan
facility: Oita University Hospital ( Site 0766)
state: Oita
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 0772)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 0762)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0767)
city: Tokyo
country: Japan
facility: Juntendo University Hospital ( Site 0768)
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital ( Site 0771)
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center ( Site 0702)
state: Kyonggi-do
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0705)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0701)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0704)
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center ( Site 0707)
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital ( Site 0911)
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital ( Site 0912)
city: Kaunas
country: Lithuania
facility: LSMUL Kauno Klinikos ( Site 0932)
city: Vilnius
country: Lithuania
facility: Nacionalinis Vezio Institutas ( Site 0931)
city: Kuching
country: Malaysia
facility: Sarawak General Hospital ( Site 0782)
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre ( Site 0781)
city: Bystra
country: Poland
facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii. ( Site 0491)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)
state: Lodzkie
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)
state: Pomorskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)
state: Wielkopolskie
city: Oradea
country: Romania
facility: S C Pelican Impex SRL ( Site 0506)
state: Bihor
city: Bucharest
country: Romania
facility: Centrul Medical Medicover Victoria ( Site 0514)
state: Bucuresti
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)
state: Cluj
city: Comuna Floresti
country: Romania
facility: SC Radiotherapy Center Cluj SRL ( Site 0509)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)
state: Dolj
city: Otopeni
country: Romania
facility: S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)
state: Ilfov
city: Timisoara
country: Romania
facility: S C Oncocenter Oncologie Medicala S R L ( Site 0505)
state: Timis
city: Brasov
country: Romania
facility: Spitalul Sf. Constantin ( Site 0512)
city: Bucuresti
country: Romania
facility: Euroclinic Hospital Bucharest ( Site 0510)
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 0513)
city: Constanta
country: Romania
facility: Spitalul clinic Judetean de urgenta Constanta ( Site 0508)
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)
state: Chelyabinskaya Oblast
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 0521)
state: Moskva
city: Moscow
country: Russian Federation
facility: National Medical Research Radiology Centre ( Site 0535)
state: Moskva
city: Moscow
country: Russian Federation
facility: Medical Rehabilitation Center ( Site 0534)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Clinical Hospital ( Site 0524)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Municipal Clinical Oncology Center ( Site 0523)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)
state: Tatarstan, Respublika
city: Tomsk
country: Russian Federation
facility: Tomsk Scientific Research Institute of Oncology ( Site 0526)
state: Tomskaya Oblast
city: Parktown-Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 0570)
state: Gauteng
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre ( Site 0573)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 0571)
state: Kwazulu-Natal
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials Pty Ltd ( Site 0572)
state: Western Cape
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)
state: Barcelona
city: L Hospitalet De Llobregat
country: Spain
facility: Instituto Catalan de Oncologia - ICO ( Site 0388)
state: Barcelona
city: Girona
country: Spain
facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)
state: La Coruna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria ( Site 0383)
state: Las Palmas
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau ( Site 0385)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 0389)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 0382)
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio ( Site 0387)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0725)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0724)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0721)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0722)
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital ( Site 0726)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0723)
city: Cherkasy
country: Ukraine
facility: Cherkassy Regional Oncological Center ( Site 0613)
state: Cherkaska Oblast
city: Dnipro
country: Ukraine
facility: City Clinical Hosp.4 of DCC ( Site 0607)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 0603)
state: Ivano-Frankivska Oblast
city: Kherson
country: Ukraine
facility: MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)
state: Khersonska Oblast
city: Kropyvnytsky
country: Ukraine
facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)
state: Kirovohradska Oblast
city: Kyiv
country: Ukraine
facility: National Cancer Institute of the MoH of Ukraine ( Site 0605)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncological Center ( Site 0601)
state: Kyivska Oblast
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 0608)
state: Odeska Oblast
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)
state: Zaporizka Oblast
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary ( Site 0447)
state: Leicestershire
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)
state: Liverpool
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 0458)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital ( Site 0457)
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital Campus ( Site 0441)
state: Nottinghamshire
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital in Birmingham ( Site 0455)
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital ( Site 0444)
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust ( Site 0443)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Wakelee 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.
citation: Romero 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.