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)

NCT03425643 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 4 other identifiers: 3475-671MK-3475-6711839702017-001832-21
• Study Type: interventional
• Target: 797
• Locations: 24 countries
• Sites: 226

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).

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Up to approximately 5 years

Secondary Outcomes (7)

• Major Pathological Response (mPR) Rate

  Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)

• Pathological Complete Response (pCR) Rate

  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

  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

  Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 71 weeks

Study Arms (2)

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 \[200 mg, IV; given on cycle day 1\].

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 \[normal saline, IV; given on cycle day 1\].

Drug: Placebo; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed

Interventions

Pembrolizumab BIOLOGICAL

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

Also known as: KEYTRUDA®, MK-3475

NAC + Neoadjuvant/Adjuvant Pembrolizumab

Placebo DRUG

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

NAC + Neoadjuvant/Adjuvant Placebo

Cisplatin DRUG

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

Also known as: PLATINOL®

NAC + Neoadjuvant/Adjuvant Pembrolizumab; NAC + Neoadjuvant/Adjuvant Placebo

Gemcitabine DRUG

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

Also known as: GEMZAR®

NAC + Neoadjuvant/Adjuvant Pembrolizumab; NAC + Neoadjuvant/Adjuvant Placebo

Pemetrexed DRUG

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

Also known as: Alimta®

NAC + Neoadjuvant/Adjuvant Pembrolizumab; NAC + Neoadjuvant/Adjuvant Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (227)

Banner MD Anderson Cancer Center ( Site 0028)

Gilbert, Arizona, 85234, United States

Location

Western Regional Medical Center, Inc. ( Site 0050)

Goodyear, Arizona, 85338, United States

Location

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

Phoenix, Arizona, 85004, United States

Location

University of Arizona Cancer Center ( Site 0012)

Tucson, Arizona, 85724, United States

Location

Pacific Cancer Medical Center, Inc. ( Site 0004)

Anaheim, California, 92801, United States

Location

Providence Saint Joseph Medical Center ( Site 0061)

Burbank, California, 91505, United States

Location

Pacific Cancer Care ( Site 0035)

Monterey, California, 93940, United States

Location

John Wayne Cancer Institute ( Site 0049)

Santa Monica, California, 90404, United States

Location

St Joseph Heritage Healthcare ( Site 0040)

Santa Rosa, California, 95403, United States

Location

Stanford University, Stanford Cancer Center ( Site 0046)

Stanford, California, 94305, United States

Location

Hartford Hospital ( Site 0069)

Hartford, Connecticut, 06102, United States

Location

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

Newark, Delaware, 19718, United States

Location

Mayo Clinic Jacksonville ( Site 0022)

Jacksonville, Florida, 32224, United States

Location

Miami Cancer Institute-Baptist Hospital ( Site 0068)

Miami, Florida, 33176, United States

Location

Southeastern Regional Medical Center ( Site 0051)

Newnan, Georgia, 30265, United States

Location

Northwest Oncology and Hematology ( Site 0001)

Elk Grove Village, Illinois, 60007, United States

Location

Ingalls Memorial Hospital ( Site 0044)

Harvey, Illinois, 60426, United States

Location

PPG-Oncology ( Site 0043)

Fort Wayne, Indiana, 46845, United States

Location

University of Iowa Hospital and Clinics ( Site 0010)

Iowa City, Iowa, 52242, United States

Location

Ashland-Bellefonte Cancer Center ( Site 0021)

Ashland, Kentucky, 41101, United States

Location

Harry & Jeanette Weinberg Cancer Institute ( Site 0081)

Baltimore, Maryland, 21237, United States

Location

Boston Medical Center ( Site 0057)

Boston, Massachusetts, 02118, United States

Location

UMass Memorial Medical Center ( Site 0030)

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Health System ( Site 0031)

Detroit, Michigan, 48202, United States

Location

Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)

Lansing, Michigan, 48912, United States

Location

Mayo Clinic ( Site 0026)

Rochester, Minnesota, 55905, United States

Location

St. Vincent Healthcare Frontier Cancer Center ( Site 0005)

Billings, Montana, 59102, United States

Location

University of Nebraska Medical Center ( Site 0047)

Omaha, Nebraska, 68198-7680, United States

Location

Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)

Middletown, New Jersey, 07748, United States

Location

MSKCC-Bergen ( Site 0075)

Montvale, New Jersey, 07645, United States

Location

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

Albany, New York, 12208, United States

Location

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

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 0060)

New York, New York, 10065, United States

Location

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

Stony Brook, New York, 11794-9447, United States

Location

Montefiore Einstein Center ( Site 0016)

The Bronx, New York, 10461, United States

Location

Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)

Uniondale, New York, 11553, United States

Location

White Plains Hospital Center for Cancer Care ( Site 0007)

White Plains, New York, 10601, United States

Location

Southwestern Regional Medical Center, Inc. ( Site 0054)

Tulsa, Oklahoma, 74133, United States

Location

OHSU Center for Health & Healing ( Site 1006)

Portland, Oregon, 97239, United States

Location

UPMC Pinnacle Health System - East Location ( Site 0063)

Harrisburg, Pennsylvania, 17109, United States

Location

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

Philadelphia, Pennsylvania, 19124, United States

Location

Allegheny General Hospital ( Site 0009)

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Hillman Cancer Centers ( Site 0041)

Pittsburgh, Pennsylvania, 15232, United States

Location

VA Pittsburgh Healthcare System ( Site 0052)

Pittsburgh, Pennsylvania, 15240, United States

Location

Saint Francis Cancer Center ( Site 0096)

Greenville, South Carolina, 29607, United States

Location

Emily Couric Clinical Cancer Center ( Site 0013)

Charlottesville, Virginia, 22903, United States

Location

Inova Schar Cancer Institute ( Site 0032)

Fairfax, Virginia, 22031, United States

Location

Virginia Cancer Specialists, PC ( Site 0080)

Fairfax, Virginia, 22031, United States

Location

Providence Regional Cancer Partnership ( Site 0065)

Everett, Washington, 98201, United States

Location

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

Berazategui, Buenos Aires, B1884BBF, Argentina

Location

Hospital Privado de Comunidad. ( Site 0130)

Mar del Plata, Buenos Aires, B7602CBM, Argentina

Location

Hospital Universitario Austral ( Site 0127)

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Fundacion Favaloro ( Site 0128)

Ciudad de Buenos Aires, Buenos Aires F.D., C1093AAS, Argentina

Location

Sanatorio Britanico ( Site 0125)

Rosario, Santa Fe Province, S2000CVB, Argentina

Location

Sanatorio Parque ( Site 0135)

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

Hospital Provincial del Centenario ( Site 0131)

Rosario, Santa Fe Province, S2002KDS, Argentina

Location

Hospital Privado Universitario de Córdoba ( Site 0139)

Córdoba, 5016, Argentina

Location

Sanatorio Allende ( Site 0129)

Córdoba, X5000JHQ, Argentina

Location

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

San Juan, J5402DIL, Argentina

Location

Orange Health Services ( Site 0624)

Orange, New South Wales, 2800, Australia

Location

Westmead Hospital ( Site 0621)

Westmead, New South Wales, 2145, Australia

Location

AZ Sint-Maarten ( Site 0226)

Mechelen, Antwerpen, 2800, Belgium

Location

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

Liège, Liege, 4000, Belgium

Location

UZ Gent ( Site 0224)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Nikolaas ( Site 0225)

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

UZ Leuven ( Site 0221)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Delta ( Site 0222)

Roeselare, West-Vlaanderen, 8800, Belgium

Location

Centro Regional Integrado de Oncologia ( Site 0160)

Fortaleza, Ceará, 60336-232, Brazil

Location

Instituto do Cancer do Ceara ( Site 0152)

Fortaleza, Ceará, 60430-230, Brazil

Location

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

Brasília, Federal District, 70200-730, Brazil

Location

Liga Norte Riograndense Contra o Cancer ( Site 0150)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Hospital de Caridade de Ijui ( Site 0153)

Ijuí, Rio Grande do Sul, 98700 000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Nossa Senhora da Conceicao ( Site 0145)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

YNOVA Pesquisa Clinica ( Site 0823)

Florianópolis, Santa Catarina, 88020-210, Brazil

Location

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

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)

Rio de Janeiro, 20230-130, Brazil

Location

Hospital Paulistano - Amil Clinical Research ( Site 0822)

São Paulo, 01321-001, Brazil

Location

Hospital Alemao Oswaldo Cruz ( Site 0158)

São Paulo, 01327-001, Brazil

Location

Princess Margaret Cancer Centre ( Site 0109)

Toronto, Ontario, M5G 2M9, Canada

Location

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

Chicoutimi, Quebec, G7H 5H6, Canada

Location

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

Montreal, Quebec, H2X 0C1, Canada

Location

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

Montreal, Quebec, H3T 1M5, Canada

Location

McGill University Health Centre ( Site 0111)

Montreal, Quebec, H4A 3J1, Canada

Location

Tianjin Medical University General Hospital ( Site 0806)

Tianjin, Anhui, 300052, China

Location

Beijing Cancer Hospital ( Site 0810)

Beijing, Beijing Municipality, 100010, China

Location

Beijing Cancer Hospital ( Site 0811)

Beijing, Beijing Municipality, 100010, China

Location

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)

Beijing, Beijing Municipality, 100021, China

Location

Peking University Third Hospital ( Site 0812)

Beijing, Beijing Municipality, 100191, China

Location

Peking Union Medical College Hospital ( Site 0809)

Beijing, Beijing Municipality, 100730, China

Location

Sun Yat-Sen University Cancer Center ( Site 0816)

Guangzhou, Guangdong, 510060, China

Location

Hunan Cancer Hospital ( Site 0815)

Changsha, Hunan, 410013, China

Location

Fudan University Shanghai Cancer Center ( Site 0813)

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan Hospital of Fudan University ( Site 0808)

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)

Shanghai, Shanghai Municipality, 200433, China

Location

Tang Du Hospital ( Site 0803)

Xi’an, Shanxi, 710038, China

Location

The First Affiliated Hospital of Zhejiang University ( Site 0804)

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital.... ( Site 0814)

Hangzhou, Zhejiang, 310022, China

Location

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

Ningbo, Zhejiang, 315010, China

Location

SA Pohja-Eesti Regionaalhaigla ( Site 1100)

Tallinn, Harju, 13419, Estonia

Location

Hopital Foch ( Site 0243)

Suresnes, Ain, 92150, France

Location

Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)

Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

Location

Nouvel Hopital Civil ( Site 0255)

Strasbourg, Bas-Rhin, 67091, France

Location

CHU de Toulouse - Hopital Larrey ( Site 0258)

Toulouse, Haute-Garonne, 31100, France

Location

Clinique Francois Chenieux ( Site 0246)

Limoges, Haute-Vienne, 87039, France

Location

Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)

Chambéry, Savoie, 73011, France

Location

Centre Hospitalier Annecy Genevois ( Site 0242)

Pringy, Savoie, 74374, France

Location

CHU de Rouen ( Site 0252)

Rouen, Seine-Maritime, 76031, France

Location

Hôpital Avicenne - Service d oncologie medicale ( Site 0249)

Bobigny, Seine-Saint-Denis, 93000, France

Location

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

Toulon, Var, 83800, France

Location

Institut Curie ( Site 0250)

Paris, 75248, France

Location

Klinikum Esslingen GmbH ( Site 0875)

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

LKI Lungenfachklinik Immenhausen ( Site 0268)

Immenhausen, Hesse, 34376, Germany

Location

Florence Nightingale Krankenhaus ( Site 0874)

Düsseldorf, North Rhine-Westphalia, 40489, Germany

Location

Lungenklinik Hemer ( Site 0269)

Hemer, North Rhine-Westphalia, 58675, Germany

Location

Mathias Spital Rheine ( Site 0261)

Rheine, North Rhine-Westphalia, 48431, Germany

Location

Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)

Koblenz, Rhineland-Palatinate, 56073, Germany

Location

Universitaetsklinikum Carl Gustav Carus ( Site 0273)

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Leipzig AOeR ( Site 0277)

Leipzig, Saxony, 04103, Germany

Location

LungenClinic Grosshansdorf GmbH ( Site 0267)

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

Universitaetsklinikum Schleswig Holstein ( Site 0871)

Kiel, Schleswig-Holstein, 24105, Germany

Location

Zentralklinik Bad Berka GmbH ( Site 0264)

Bad Berka, Thuringia, 99437, Germany

Location

SRH Waldklinikum Gera GmbH ( Site 0272)

Gera, Thuringia, 07548, Germany

Location

Evangelische Lungenklinik Berlin ( Site 0274)

Berlin, 13125, Germany

Location

HELIOS Klinikum Emil von Behring ( Site 0280)

Berlin, 14165, Germany

Location

Asklepios Klinikum Hamburg ( Site 0271)

Hamburg, 21075, Germany

Location

Cork University Hospital ( Site 0452)

Wilton, Cork, Ireland

Location

St James Hospital ( Site 0451)

Dublin, D08 K0Y5, Ireland

Location

Mid Western Cancer Centre ( Site 0450)

Limerick, V98F858, Ireland

Location

Istituto Nazionale Tumori ( Site 0309)

Milano, Abruzzo, 20133, Italy

Location

Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)

Napoli, Campania, 80131, Italy

Location

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

Meldola, Forli-Cesena, 47014, Italy

Location

Istituto Clinico Humanitas Research Hospital ( Site 0314)

Rozzano, Lombardy, 20089, Italy

Location

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

Milan, Milano, 20162, Italy

Location

Azienda Ospedaliera San Gerardo ( Site 0308)

Monza, Monza E Brianza, 20900, Italy

Location

AOU San Luigi Gonzaga di Orbassano ( Site 0313)

Orbassano, Torino, 10043, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)

Brescia, 25123, Italy

Location

IRCCS Ospedale San Raffaele di Milano ( Site 0303)

Milan, 20132, Italy

Location

Azienda Ospedaliera San Camillo Forlanini ( Site 0311)

Roma, 00152, Italy

Location

Aichi Cancer Center Hospital ( Site 0765)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 0761)

Kashiwa, Chiba, 277-8577, Japan

Location

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

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Hyogo Cancer Center ( Site 0764)

Akashi, Hyōgo, 673-8558, Japan

Location

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

Kawasaki, Kanagawa, 216-8511, Japan

Location

Kanagawa Cancer Center ( Site 0763)

Yokohama, Kanagawa, 241-8515, Japan

Location

Oita University Hospital ( Site 0766)

Yufu, Oita Prefecture, 879-5593, Japan

Location

Fukushima Medical University Hospital ( Site 0772)

Fukushima, 960-1295, Japan

Location

Hiroshima University Hospital ( Site 0762)

Hiroshima, 734-8551, Japan

Location

National Cancer Center Hospital ( Site 0767)

Tokyo, 104-0045, Japan

Location

Juntendo University Hospital ( Site 0768)

Tokyo, 113-8431, Japan

Location

Tokyo Medical University Hospital ( Site 0771)

Tokyo, 160-0023, Japan

Location

Pauls Stradins Clinical University Hospital ( Site 0911)

Riga, 1002, Latvia

Location

Riga East Clinical University Hospital ( Site 0912)

Riga, 1079, Latvia

Location

LSMUL Kauno Klinikos ( Site 0932)

Kaunas, 50161, Lithuania

Location

Nacionalinis Vezio Institutas ( Site 0931)

Vilnius, 08406, Lithuania

Location

Sarawak General Hospital ( Site 0782)

Kuching, Sarawak, 93586, Malaysia

Location

University Malaya Medical Centre ( Site 0781)

Kuala Lumpur, 59100, Malaysia

Location

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)

Poznan, Greater Poland Voivodeship, 60-569, Poland

Location

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)

Bystra, Lower Silesian Voivodeship, 43-360, Poland

Location

Dolnoslaskie Centrum Onkologii. ( Site 0491)

Wroclaw, Lower Silesian Voivodeship, 53-413, Poland

Location

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

Prabuty, Pomeranian Voivodeship, 82-550, Poland

Location

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

Lodz, Łódź Voivodeship, 93-513, Poland

Location

S C Pelican Impex SRL ( Site 0506)

Oradea, Bihor County, 410450, Romania

Location

Centrul Medical Medicover Victoria ( Site 0514)

Bucharest, București, 010626, Romania

Location

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

Cluj-Napoca, Cluj, 400015, Romania

Location

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

Cluj-Napoca, Cluj, 400015, Romania

Location

SC Radiotherapy Center Cluj SRL ( Site 0509)

Comuna Floresti, Cluj, 407280, Romania

Location

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

Craiova, Dolj, 200347, Romania

Location

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

Otopeni, Ilfov, 075100, Romania

Location

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

Timișoara, Timiș County, 300166, Romania

Location

Spitalul Sf. Constantin ( Site 0512)

Brasov, 500091, Romania

Location

Euroclinic Hospital Bucharest ( Site 0510)

Bucharest, 014461, Romania

Location

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

Bucharest, 021389, Romania

Location

Spitalul clinic Judetean de urgenta Constanta ( Site 0508)

Constanța, 900591, Romania

Location

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

Suceava, 720237, Romania

Location

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)

Chelyabinsk, Chelyabinsk Oblast, 454087, Russia

Location

N.N. Blokhin NMRCO ( Site 0521)

Moscow, Moscow, 115478, Russia

Location

National Medical Research Radiology Centre ( Site 0535)

Moscow, Moscow, 125284, Russia

Location

Medical Rehabilitation Center ( Site 0534)

Moscow, Moscow, 125367, Russia

Location

SBHI Leningrad Regional Clinical Hospital ( Site 0524)

Saint Petersburg, Sankt-Peterburg, 194291, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Municipal Clinical Oncology Center ( Site 0523)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

Tomsk Scientific Research Institute of Oncology ( Site 0526)

Tomsk, Tomsk Oblast, 634028, Russia

Location

Wits Clinical Research ( Site 0570)

Parktown-Johannesburg, Gauteng, 2193, South Africa

Location

Wilgers Oncology Centre ( Site 0573)

Pretoria, Gauteng, 0081, South Africa

Location

The Oncology Centre ( Site 0571)

Durban, KwaZulu-Natal, 4001, South Africa

Location

Cape Town Oncology Trials Pty Ltd ( Site 0572)

Kraaifontein, Western Cape, 7570, South Africa

Location

National Cancer Center ( Site 0702)

Gyeonggi-do, Kyonggi-do, 10408, South Korea

Location

The Catholic University of Korea St. Vincent s Hospital ( Site 0705)

Gyeonggi-do, Kyonggi-do, 16247, South Korea

Location

Asan Medical Center ( Site 0701)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 0704)

Seoul, 06351, South Korea

Location

SMG-SNU Boramae Medical Center ( Site 0707)

Seoul, 07071, South Korea

Location

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

Badalona, Barcelona, 08916, Spain

Location

Instituto Catalan de Oncologia - ICO ( Site 0388)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)

Girona, La Coruna, 17007, Spain

Location

Hospital Universitario Insular de Gran Canaria ( Site 0383)

Las Palmas de Gran Canaria, Las Palmas, 35001, Spain

Location

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

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d Hebron ( Site 0389)

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 0382)

Madrid, 28009, Spain

Location

Hospital Virgen del Rocio ( Site 0387)

Seville, 41013, Spain

Location

Kaohsiung Chang Gung Memorial Hospital ( Site 0725)

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital ( Site 0724)

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital ( Site 0721)

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital ( Site 0722)

Taipei, 112, Taiwan

Location

Tri-Service General Hospital ( Site 0726)

Taipei, 114, Taiwan

Location

Chang Gung Medical Foundation.Linkou Branch ( Site 0723)

Taoyuan District, 333, Taiwan

Location

Cherkassy Regional Oncological Center ( Site 0613)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

Location

City Clinical Hosp.4 of DCC ( Site 0607)

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

MI Precarpathian Clinical Oncology Center ( Site 0603)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)

Kherson, Kherson Oblast, 73000, Ukraine

Location

PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)

Kropyvnytsky, Kirovohrad Oblast, 25006, Ukraine

Location

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

Kyiv, Kyivska Oblast, 03022, Ukraine

Location

Kyiv City Clinical Oncological Center ( Site 0601)

Kyiv, Kyivska Oblast, 03115, Ukraine

Location

MI Odessa Regional Oncological Centre ( Site 0608)

Odesa, Odesa Oblast, 65055, Ukraine

Location

Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)

Zaporizhzhya, Zaporizhzhia Oblast, 69040, Ukraine

Location

Leicester Royal Infirmary ( Site 0447)

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)

Metropolitan Borough of Wirral, Liverpool, CH63 4JY, United Kingdom

Location

Royal Marsden NHS Foundation Trust ( Site 0458)

London, London, City of, SW3 6JJ, United Kingdom

Location

Royal Marsden Hospital ( Site 0457)

Sutton, London, City of, SM2 5PT, United Kingdom

Location

Nottingham City Hospital Campus ( Site 0441)

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Heartlands Hospital in Birmingham ( Site 0455)

Birmingham, B9 5SS, United Kingdom

Location

Freeman Hospital ( Site 0444)

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Plymouth Hospitals NHS Trust ( Site 0443)

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 39288781 RESULT

• 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.

  PMID: 37272513 RESULT

• Aredo 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.

  PMID: 38717993 DERIVED

• 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.

  PMID: 33661301 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Cisplatin; Gemcitabine; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

clinicaltrialsdisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 7, 2018
• Study Start: April 24, 2018
• Primary Completion: July 10, 2023
• Study Completion (Estimated): June 29, 2026
• Last Updated: December 3, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (8); LA (2); AR (10); RO (13); IT (10); RU (9); CN (15); FR (11); LI (2); TW (6); UA (9); GB (8); BE (6); MY (2); US (51); PL (6); IE (3); KR (5); AU (2); CA (5); DE (15); JP (12); ZA (4); BR (12)