Lung Cancer Clinical Trial
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)
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 220 Locations for this study
Gilbert Arizona, 85234, United States
Goodyear Arizona, 85338, United States
Phoenix Arizona, 85004, United States
Tucson Arizona, 85724, United States
Anaheim California, 92801, United States
Burbank California, 91505, United States
Monterey California, 93940, United States
Santa Monica California, 90404, United States
Santa Rosa California, 95403, United States
Stanford California, 94305, United States
Hartford Connecticut, 06102, United States
Newark Delaware, 19718, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33176, United States
Newnan Georgia, 30265, United States
Elk Grove Village Illinois, 60007, United States
Harvey Illinois, 60426, United States
Fort Wayne Indiana, 46845, United States
Iowa City Iowa, 52242, United States
Ashland Kentucky, 41101, United States
Baltimore Maryland, 21237, United States
Boston Massachusetts, 02118, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48202, United States
Lansing Michigan, 48912, United States
Rochester Minnesota, 55905, United States
Billings Montana, 59102, United States
Omaha Nebraska, 68198, United States
Basking Ridge New Jersey, 07920, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Stony Brook New York, 11794, United States
Uniondale New York, 11553, United States
White Plains New York, 10601, United States
Tulsa Oklahoma, 74133, United States
Portland Oregon, 97239, United States
Harrisburg Pennsylvania, 17109, United States
Philadelphia Pennsylvania, 19124, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Pittsburgh Pennsylvania, 15240, United States
Greenville South Carolina, 29607, United States
Charlottesville Virginia, 22903, United States
Fairfax Virginia, 22031, United States
Fairfax Virginia, 22031, United States
Everett Washington, 98201, United States
Berazategui Buenos Aires, B1884, Argentina
Mar del Plata Buenos Aires, B7602, Argentina
Pilar Buenos Aires, B1629, Argentina
Ciudad de Buenos Aires Caba, C1093, Argentina
Rosario Santa Fe, S2000, Argentina
Rosario Santa Fe, S2000, Argentina
Rosario Santa Fe, S2002, Argentina
Cordoba , 5016, Argentina
Cordoba , X5000, Argentina
San Juan , J5402, Argentina
Orange New South Wales, 2800, Australia
Westmead New South Wales, 2145, Australia
Mechelen Antwerpen, 2800, Belgium
Liège Liege, 4000, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Sint-Niklaas Oost-Vlaanderen, 9100, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Roeselare West-Vlaanderen, 8800, Belgium
Fortaleza Ceara, 60336, Brazil
Fortaleza Ceara, 60430, Brazil
Brasilia Distrito Federal, 70200, Brazil
Natal Rio Grande Do Norte, 59075, Brazil
Ijui Rio Grande Do Sul, 98700, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Florianopolis Santa Catarina, 88020, Brazil
Barretos Sao Paulo, 14784, Brazil
Rio de Janeiro , 20230, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 01327, Brazil
Toronto Ontario, M5G 2, Canada
Chicoutimi Quebec, G7H 5, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A 3, Canada
Tianjin Anhui, 30005, China
Beijing Beijing, 10001, China
Beijing Beijing, 10001, China
Beijing Beijing, 10002, China
Beijing Beijing, 10019, China
Beijing Beijing, 10073, China
Guangzhou Guangdong, 51006, China
Changsha Hunan, 41001, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20043, China
XI An Shanxi, 71003, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Ningbo Zhejiang, 31501, China
Tallinn Harjumaa, 13419, Estonia
Suresnes Ain, 92150, France
Strasbourg Bas-Rhin, 67091, France
Toulouse Haute-Garonne, 31100, France
Limoges Haute-Vienne, 87039, France
Pierre-Benite Rhone-Alpes, 69310, France
Chambery Savoie, 73011, France
Pringy Savoie, 74374, France
Rouen Seine-Maritime, 76031, France
Bobigny Seine-Saint-Denis, 93000, France
Toulon Var, 83800, France
Paris , 75248, France
Esslingen Baden-Wurttemberg, 73730, Germany
Immenhausen Hessen, 34376, Germany
Duesseldorf Nordrhein-Westfalen, 40489, Germany
Hemer Nordrhein-Westfalen, 58675, Germany
Rheine Nordrhein-Westfalen, 48431, Germany
Koblenz Rheinland-Pfalz, 56073, Germany
Dresden Sachsen, 01307, Germany
Leipzig Sachsen, 04103, Germany
Grosshansdorf Schleswig-Holstein, 22927, Germany
Kiel Schleswig-Holstein, 24105, Germany
Bad Berka Thuringen, 99437, Germany
Gera Thuringen, 07548, Germany
Berlin , 13125, Germany
Berlin , 14165, Germany
Hamburg , 21075, Germany
Wilton Cork, , Ireland
Dublin , D08 K, Ireland
Limerick , V98F8, Ireland
Milano Abruzzo, 20133, Italy
Napoli Campania, 80131, Italy
Meldola Forli-Cesena, 47014, Italy
Rozzano Lombardia, 20089, Italy
Milan Milano, 20162, Italy
Monza Monza E Brianza, 20900, Italy
Orbassano Torino, 10043, Italy
Brescia , 25123, Italy
Milano , 20132, Italy
Roma , 00152, Italy
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, Japan
Kitakyushu Fukuoka, 807-8, Japan
Akashi Hyogo, 673-8, Japan
Kawasaki Kanagawa, 216-8, Japan
Yokohama Kanagawa, 241-8, Japan
Yufu Oita, 879-5, Japan
Fukushima , 960-1, Japan
Hiroshima , 734-8, Japan
Tokyo , 104-0, Japan
Tokyo , 113-8, Japan
Tokyo , 160-0, Japan
Gyeonggi-do Kyonggi-do, 10408, Korea, Republic of
Gyeonggi-do Kyonggi-do, 16247, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 07071, Korea, Republic of
Riga , 1002, Latvia
Riga , 1079, Latvia
Kaunas , 50161, Lithuania
Vilnius , 08406, Lithuania
Kuching Sarawak, 93586, Malaysia
Kuala Lumpur , 59100, Malaysia
Bystra Dolnoslaskie, 43-36, Poland
Wroclaw Dolnoslaskie, 53-41, Poland
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Lodz Lodzkie, 93-51, Poland
Prabuty Pomorskie, 82-55, Poland
Poznan Wielkopolskie, 60-56, Poland
Oradea Bihor, 41045, Romania
Bucharest Bucuresti, 01062, Romania
Cluj Napoca Cluj, 40001, Romania
Cluj-Napoca Cluj, 40001, Romania
Comuna Floresti Cluj, 40728, Romania
Craiova Dolj, 20034, Romania
Otopeni Ilfov, 07510, Romania
Timisoara Timis, 30016, Romania
Brasov , 50009, Romania
Bucuresti , 01446, Romania
Bucuresti , 02138, Romania
Constanta , 90059, Romania
Suceava , 72023, Romania
Chelyabinsk Chelyabinskaya Oblast, 45408, Russian Federation
Moscow Moskva, 11547, Russian Federation
Moscow Moskva, 12528, Russian Federation
Moscow Moskva, 12536, Russian Federation
Saint Petersburg Sankt-Peterburg, 19429, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Tomsk Tomskaya Oblast, 63402, Russian Federation
Parktown-Johannesburg Gauteng, 2193, South Africa
Pretoria Gauteng, 0081, South Africa
Durban Kwazulu-Natal, 4001, South Africa
Kraaifontein Western Cape, 7570, South Africa
Badalona Barcelona, 08916, Spain
L Hospitalet De Llobregat Barcelona, 08908, Spain
Girona La Coruna, 17007, Spain
Las Palmas de Gran Canaria Las Palmas, 35001, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Madrid , 28009, Spain
Sevilla , 41013, Spain
Kaohsiung , 83301, Taiwan
Taichung , 40447, Taiwan
Taipei , 10048, Taiwan
Taipei , 112, Taiwan
Taipei , 114, Taiwan
Taoyuan , 333, Taiwan
Cherkasy Cherkaska Oblast, 18009, Ukraine
Dnipro Dnipropetrovska Oblast, 49102, Ukraine
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
Kherson Khersonska Oblast, 73000, Ukraine
Kropyvnytsky Kirovohradska Oblast, 25006, Ukraine
Kyiv Kyivska Oblast, 03022, Ukraine
Kyiv Kyivska Oblast, 03115, Ukraine
Odesa Odeska Oblast, 65055, Ukraine
Zaporizhzhya Zaporizka Oblast, 69040, Ukraine
Leicester Leicestershire, LE1 5, United Kingdom
Wirral Liverpool, CH63 , United Kingdom
London London, City Of, SW3 6, United Kingdom
Sutton London, City Of, SM2 5, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Birmingham , B9 5S, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom
Plymouth , PL6 8, United Kingdom
How clear is this clinincal trial information?