Spots Global Cancer Trial Database for Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)
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Trial Identification
Brief Title: Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)
Official Title: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)
Study ID: NCT03924869
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama ( Site 0099), Birmingham, Alabama, United States
Infirmary Cancer Care ( Site 3044), Mobile, Alabama, United States
Alaska Oncology and Hematology ( Site 3063), Anchorage, Alaska, United States
Banner MD Anderson Cancer Center ( Site 3029), Gilbert, Arizona, United States
CARTI Cancer Center ( Site 3045), Little Rock, Arkansas, United States
USC Norris Comprehensive Cancer Center ( Site 0007), Los Angeles, California, United States
Veterans Affairs Palo Alto Health Care System ( Site 3039), Palo Alto, California, United States
National Jewish Health ( Site 0010), Denver, Colorado, United States
Yale University ( Site 0011), New Haven, Connecticut, United States
Mid Florida Hematology and Oncology Center ( Site 0067), Orange City, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute ( Site 0016), Tampa, Florida, United States
Goshen Center for Cancer Care ( Site 0022), Goshen, Indiana, United States
Franciscan Health Indianapolis ( Site 0024), Indianapolis, Indiana, United States
University of Kentucky School of Medicine & Hospitals ( Site 0026), Lexington, Kentucky, United States
Sinai Hospital of Baltimore ( Site 3011), Baltimore, Maryland, United States
William E. Kahlert Regional Cancer Center ( Site 3031), Westminster, Maryland, United States
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007), Boston, Massachusetts, United States
Mass General / North Shore Center for Outpatient Care ( Site 3040), Danvers, Massachusetts, United States
University of Massachusetts ( Site 0029), Worcester, Massachusetts, United States
Sanford Bemidji ( Site 0080), Bemidji, Minnesota, United States
University of Minnesota ( Site 0069), Minneapolis, Minnesota, United States
University of Missouri Hospital ( Site 3058), Columbia, Missouri, United States
Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060), Springfield, Missouri, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 3012), Billings, Montana, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036), Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0043), New Brunswick, New Jersey, United States
Hematology-Oncology Associates of CNY ( Site 3055), East Syracuse, New York, United States
Mount Sinai Hospital ( Site 0046), New York, New York, United States
Westchester Medical Center ( Site 3057), Valhalla, New York, United States
White Plains Hospital ( Site 3014), White Plains, New York, United States
Sanford Health Roger Maris Cancer Center ( Site 0079), Fargo, North Dakota, United States
Lehigh Valley Hospital- Cedar Crest ( Site 3005), Allentown, Pennsylvania, United States
St. Luke's University Health Network ( Site 3006), Bethlehem, Pennsylvania, United States
Penn State University Milton S. Hershey Medical Center ( Site 0064), Hershey, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0051), Philadelphia, Pennsylvania, United States
Allegheny General Hospital ( Site 3028), Pittsburgh, Pennsylvania, United States
Lankenau Medical Center ( Site 3041), Wynnewood, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 0053), Sioux Falls, South Dakota, United States
Mountain States Health Alliance ( Site 3054), Johnson City, Tennessee, United States
University of Tennessee Medical Center Knoxville ( Site 3010), Knoxville, Tennessee, United States
Vanderbilt University Medical Center ( Site 0075), Nashville, Tennessee, United States
Cancer Care Northwest ( Site 0063), Spokane Valley, Washington, United States
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206), ABB, Caba, Argentina
Hospital Britanico de Buenos Aires ( Site 0204), Buenos Aires, Caba, Argentina
Sanatorio Parque ( Site 0207), Rosario, Santa Fe, Argentina
Hospital Provincial del Centenario ( Site 0205), Rosario, Santa Fe, Argentina
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208), Buenos Aires, , Argentina
Hospital Aleman ( Site 0200), Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming ( Site 0203), Buenos Aires, , Argentina
CEMIC ( Site 0201), Buenos Aires, , Argentina
Port Macquarie Base Hospital ( Site 2500), Port Macquarie, New South Wales, Australia
GenesisCare North Shore ( Site 2508), St Leonards, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 2502), Herston, Queensland, Australia
Icon Cancer Centre Hobart ( Site 2507), Hobart, Tasmania, Australia
Austin Health ( Site 2501), Melbourne, Victoria, Australia
Keppler Universitatsklinikum ( Site 0806), Linz, Oberosterreich, Austria
Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804), Graz, Steiermark, Austria
Universitatsklinik LKH Innsbruck ( Site 0802), Innsbruck, Tirol, Austria
Social Medical Center - Otto Wagner Hospital ( Site 0801), Vienna, Wien, Austria
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318), Porto Alegre, Rio Grande Do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301), Porto Alegre, Rio Grande Do Sul, Brazil
Clínica de Oncologia Reichow ( Site 0319), Blumenau, Santa Catarina, Brazil
Hospital e Maternidade Celso Pierro ( Site 0313), Campinas, Sao Paulo, Brazil
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305), Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300), Sao Paulo, , Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0316), Sao Paulo, , Brazil
A.C. Camargo Cancer Center ( Site 0312), Sao Paulo, , Brazil
Moncton Hospital - Horizon Health Network ( Site 0105), Moncton, New Brunswick, Canada
Kingston Health Sciences Centre ( Site 0100), Kingston, Ontario, Canada
Trillium Health Partners - Credit Valley Hospital ( Site 0102), Mississauga, Ontario, Canada
The Ottawa Hospital ( Site 0104), Ottawa, Ontario, Canada
Sault Area Hospital ( Site 0101), Sault Ste Marie, Ontario, Canada
Health Sciences North Research Institute ( Site 0107), Sudbury, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110), Montreal, Quebec, Canada
McGill University Health Centre ( Site 0113), Montréal, Quebec, Canada
CHUS - Hopital Fleurimont ( Site 0111), Sherbrooke, Quebec, Canada
CHU Poitiers ( Site 1109), Poitiers, Ain, France
CHU de Brest -Site Hopital Morvan ( Site 1100), Brest, Finistere, France
Institut Bergonie ( Site 1102), Bordeaux, Gironde, France
Institut Regional du Cancer de Montpellier - ICM ( Site 1108), Montpellier, Herault, France
CHU de Rouen ( Site 1113), Rouen, Seine-Maritime, France
Hopital Sud du Amiens ( Site 1115), Amiens, Somme, France
Institut Curie ( Site 1112), Paris, , France
Hopital Cochin ( Site 1107), Paris, , France
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114), Paris, , France
Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208), Esslingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg. ( Site 1204), Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen ( Site 1209), Erlangen, Bayern, Germany
UKGM Gießen/Marburg-Medical Clinic V ( Site 1210), Gießen, Hessen, Germany
Pius Hospital Oldenburg ( Site 1202), Oldenburg, Niedersachsen, Germany
Universitaetsklinikum Essen ( Site 1201), Essen, Nordrhein-Westfalen, Germany
Evangelisches Krankenhaus Hamm gGmbH ( Site 1205), Hamm, Nordrhein-Westfalen, Germany
Charite Universitaetsmedizin Berlin ( Site 1207), Berlin, , Germany
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311), Kecskemét, Bacs-Kiskun, Hungary
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314), Pécs, Baranya, Hungary
CRU Hungary KFT ( Site 2309), Miskolc, Borsod-Abauj-Zemplen, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312), Szekesfehervar, Fejer, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 2305), Gyor, Gyor-Moson-Sopron, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 2301), Debrecen, Hajdu-Bihar, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Törökbálinti Tüdőgyógyintézet ( Site 2302), Torokbalint, Pest, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307), Kaposvar, Somogy, Hungary
Farkasgyepui Tudogyogyintezet ( Site 2313), Farkasgyepu, Veszprem, Hungary
Semmelweis University ( Site 2303), Budapest, , Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 2304), Budapest, , Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 2306), Budapest, , Hungary
Orszagos Onkologiai Intezet ( Site 2308), Budapest, , Hungary
Ospedale Santissima Annunziata ( Site 1303), Chieti, , Italy
A.O. Universitaria Careggi ( Site 1301), Firenze, , Italy
Policlinico di Modena ( Site 1306), Modena, , Italy
Policlinico Agostino Gemelli ( Site 1302), Roma, , Italy
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309), Roma, , Italy
Aichi Cancer Center Hospital ( Site 2804), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 2800), Kashiwa, Chiba, Japan
Kurume University Hospital ( Site 2815), Kurume, Fukuoka, Japan
Kobe Minimally Invasive Cancer Center ( Site 2811), Kobe, Hyogo, Japan
University of Tsukuba Hospital ( Site 2809), Tsukuba, Ibaraki, Japan
Sendai Kousei Hospital ( Site 2814), Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 2808), Hirakata, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 2813), Takatsuki, Osaka, Japan
University of Yamanashi Hospital ( Site 2807), Chuo, Yamanashi, Japan
Chiba University Hospital ( Site 2806), Chiba, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 2816), Fukuoka, , Japan
Hiroshima University Hospital ( Site 2810), Hiroshima, , Japan
Niigata Cancer Center Hospital ( Site 2801), Niigata, , Japan
Osaka International Cancer Institute ( Site 2812), Osaka, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 2802), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 2803), Tokyo, , Japan
Showa University Hospital ( Site 2805), Tokyo, , Japan
Chungbuk National University Hospital ( Site 2605), Cheongju-si, Chungbuk, Korea, Republic of
National Cancer Center ( Site 2604), Goyang-si, Kyonggi-do, Korea, Republic of
The Catholic University of Korea St. Vincent s Hospital ( Site 2606), Gyeonggi-do, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 2600), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 2603), Seoul, , Korea, Republic of
Ziekenhuis Rijnstate ( Site 1405), Arnhem, Gelderland, Netherlands
Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407), Hilversum, Noord-Holland, Netherlands
Meander Medisch Centrum-Studie Team Oncologie ( Site 1403), Amersfoort, Utrecht, Netherlands
Auckland City Hospital ( Site 2900), Grafton, Auckland, New Zealand
St Olavs Hospital ( Site 1504), Trondheim, Sor-Trondelag, Norway
Helse Bergen HF Haukeland Universitetssykehus ( Site 1502), Bergen, Vestfold, Norway
Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500), Oslo, , Norway
Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407), Bydgoszcz, Kujawsko-pomorskie, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402), Lodz, Lodzkie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400), Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403), Gliwice, Slaskie, Poland
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404), Olsztyn, Warminsko-mazurskie, Poland
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201), Florești, Cluj, Romania
Institutul Oncologic-Oncologie Medicala ( Site 3202), Cluj, , Romania
Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014), Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
GUZ Lipetsk Regional Oncology Dispensary ( Site 2010), Lipetsk, Lipetskaya Oblast, Russian Federation
N.N.Blokhin Russian Cancer Research center ( Site 2013), Moscow, Moskva, Russian Federation
Russian Scientific Center of Roentgenoradiology ( Site 2011), Moscow, Moskva, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Medical institute named after Berezin Sergey ( Site 2009), St. Petersburg, Sankt-Peterburg, Russian Federation
Sverdlovsk Regional Oncology Hospital ( Site 2012), Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001), Kazan, Tatarstan, Respublika, Russian Federation
Hospital Universitario Quiron Madrid ( Site 1601), Pozuelo de Alarcon, Madrid, Spain
Hospital Universitario La Fe ( Site 1603), Valencia, Valenciana, Comunitat, Spain
Hospital General Universitari Vall d Hebron ( Site 1602), Barcelona, , Spain
Hospital General Universitario Gregorio Maranon ( Site 1604), Madrid, , Spain
Hopitaux Universitaires de Geneve HUG ( Site 1706), Geneva, Geneve, Switzerland
Universitaetsspital Zuerich ( Site 1700), Zuerich, Zurich, Switzerland
Tri-Service General Hospital ( Site 3300), Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304), Kaohsiung, , Taiwan
Taipei Medical University Hospital ( Site 3303), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 3301), Taipei, , Taiwan
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105), Adana, , Turkey
Hacettepe University Medical Faculty ( Site 2100), Ankara, , Turkey
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101), Ankara, , Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116), Istanbul, , Turkey
Kartal Training and Research Hospital ( Site 2102), Istanbul, , Turkey
I.E.U. Medical Point Hastanesi ( Site 2115), Izmir, , Turkey
Erciyes University Medical Faculty ( Site 2109), Kayseri, , Turkey
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114), Sakarya, , Turkey
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207), Dnipro, Dnipropetrovska Oblast, Ukraine
Regional Centre of Oncology-Thoracic organs ( Site 2202), Kharkiv, Kharkivska Oblast, Ukraine
Ukrainian Center of Tomotherapy ( Site 2206), Kropyvnitskiy, Kirovohradska Oblast, Ukraine
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205), Kapitanivka Village, Kyivska Oblast, Ukraine
Medical Center Asklepion LLC ( Site 2208), Khodosivka, Kyivska Oblast, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203), Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2200), Kyiv, , Ukraine
University Hospitals Bristol NHS Foundation Trust ( Site 1802), Bristol, Bristol, City Of, United Kingdom
Royal Free London NHS Foundation Trust ( Site 1813), London, Camden, United Kingdom
Weston Park Hospital ( Site 1801), Sheffield, Derbyshire, United Kingdom
Clatterbridge Cancer Center NHS FT ( Site 1800), Liverpool, England, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809), Preston, Lancashire, United Kingdom
Leicester Royal Infirmary ( Site 1811), Leicester, Leicestershire, United Kingdom
University College London Hospital NHS Foundation Trust ( Site 1806), London, London, City Of, United Kingdom
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808), London, London, City Of, United Kingdom
Norfolk and Norwich University Foundation NHS Trust ( Site 1805), Norwich, Norfolk, United Kingdom
Oxford University Hospitals NHS Foundation Trust ( Site 1812), Oxford, Oxfordshire, United Kingdom
Darlington Memorial Hospital NHS Trust ( Site 1810), Darlington, , United Kingdom
Mount Vernon Hospital ( Site 1803), Northwood, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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