Spots Global Cancer Trial Database for Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
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Trial Identification
Brief Title: Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
Official Title: A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT04380636
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: 1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) 2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama, Mitchell Cancer Institute ( Site 0003), Mobile, Alabama, United States
St. Bernards Medical Center ( Site 0089), Jonesboro, Arkansas, United States
St Joseph Heritage Healthcare-Oncology ( Site 0088), Fullerton, California, United States
Long Beach Memorial Medical Center ( Site 0006), Long Beach, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0013), Los Angeles, California, United States
St. Joseph Heritage Healthcare Local Lab ( Site 0011), Santa Rosa, California, United States
Torrance Memorial Physician Network / Cancer Center ( Site 0093), Torrance, California, United States
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095), Hollywood, Florida, United States
Miami VA Healthcare System ( Site 0024), Miami, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 0022), Orange City, Florida, United States
Orlando Health, UF Health Cancer Center Inc ( Site 0092), Orlando, Florida, United States
Fort Wayne Medical Oncology and Hematology ( Site 0094), Fort Wayne, Indiana, United States
Parkview Research Center ( Site 0032), Fort Wayne, Indiana, United States
Franciscan Health Lafayette East ( Site 0031), Lafayette, Indiana, United States
University of Kentucky ( Site 0096), Lexington, Kentucky, United States
Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035), Louisville, Kentucky, United States
Pikeville Medical Center ( Site 0036), Pikeville, Kentucky, United States
Massachusetts General Hospital ( Site 0038), Boston, Massachusetts, United States
Henry Ford Hospital ( Site 0045), Detroit, Michigan, United States
VA St. Louis Health Care System ( Site 0047), Saint Louis, Missouri, United States
Washington University Siteman Cancer Center ( Site 0046), Saint Louis, Missouri, United States
CHI Health St. Francis ( Site 0053), Grand Island, Nebraska, United States
Rutgers Cancer Institute of New Jersey ( Site 0054), New Brunswick, New Jersey, United States
The Valley Hospital ( Site 0056), Paramus, New Jersey, United States
Montefiore Einstein Center ( Site 0083), Bronx, New York, United States
Novant Health Presbyterian ( Site 0081), Charlotte, North Carolina, United States
Duke University Medical Center ( Site 0050), Durham, North Carolina, United States
Piedmont Hematology-Oncology Associates ( Site 0080), Winston-Salem, North Carolina, United States
The Lindner Center for Research and Education at The Christ Hospital ( Site 0060), Cincinnati, Ohio, United States
Fox Chase Cancer Center ( Site 0063), Philadelphia, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 0066), Sioux Falls, South Dakota, United States
Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075), Seattle, Washington, United States
Cancer Care Northwest ( Site 0074), Spokane Valley, Washington, United States
Instituto MĂ©dico RĂo Cuarto ( Site 4003), RĂo Cuarto, Cordoba, Argentina
Clinica Adventista Belgrano-Oncology ( Site 4002), Caba, , Argentina
Queen Elizabeth II Health Sciences Centre ( Site 0100), Halifax, Nova Scotia, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102), Montreal, Quebec, Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108), Montreal, Quebec, Canada
McGill University Health Center - Research Institute ( Site 0114), Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, HÎpital de l'Enfant-Jésus ( Site 0, Quebec, , Canada
Centro InvestigaciĂłn del CĂĄncer James Lind ( Site 0202), Temuco, Araucania, Chile
OrlandiOncologia ( Site 0201), Santiago, Region M. De Santiago, Chile
Bradfordhill ( Site 0200), Santiago, Region M. De Santiago, Chile
Oncocentro ( Site 0203), Vina del Mar, Valparaiso, Chile
Bradford Hill Norte ( Site 0204), Antofagasta, , Chile
Beijing Cancer Hospital ( Site 3224), Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 3201), Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 3212), Beijing, Beijing, China
Daping Hospital,Third Military Medical University ( Site 3235), Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital ( Site 3226), Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 3219), Xiamen, Fujian, China
Peking University Shenzhen Hospital ( Site 3216), Shenzhen, Guangdong, China
Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200), Shenzhen, Guangdong, China
Henan Cancer Hospital ( Site 3205), Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 3222), Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 3218), Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 3238), Changsha, Hunan, China
Xiangya Hospital of Central South University ( Site 3637), Changsha, Hunan, China
Second Xiangya Hospital of Central-South University ( Site 3227), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 3225), Changsha, Hunan, China
Jiangsu Cancer Hospital ( Site 3234), Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University ( Site 3206), Nanchang, Jiangxi, China
Jilin Cancer Hospital ( Site 3230), Changchun, Jilin, China
Shanghai Chest Hospital ( Site 3207), Shangai, Shanghai, China
Zhongshan Hospital Fudan University ( Site 3220), Shanghai, Shanghai, China
Shanghai Pulmonary Hospital ( Site 3203), Shanghai, Shanghai, China
West China Hospital of Sichuan University ( Site 3202), Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 3204), Tianjin, Tianjin, China
The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232), Hangzhou, Zhejiang, China
Masarykuv onkologicky ustav ( Site 2206), Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava ( Site 2201), Ostrava, Ostrava Mesto, Czechia
Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200), PRague, Praha 10, Czechia
Fakultni nemocnice v Motole ( Site 2210), Praha, Praha, Hlavni Mesto, Czechia
Nemocnice Na Plesi s.r.o. ( Site 2202), Nova Ves pod Plesi, Pribram, Czechia
Krajska nemocnice Liberec, a.s. ( Site 2209), Liberec, , Czechia
Vseobecna fakultni nemocnice v Praze ( Site 2208), Praha 2, , Czechia
Nemocnice Na Bulovce ( Site 2205), Praha 8, , Czechia
North Estonia Medical Centre Foundation ( Site 1601), Tallin, Harjumaa, Estonia
Tartu University Hospital ( Site 1600), Tartu, Tartumaa, Estonia
Clinique Clairval ( Site 0802), Marseille, Bouches-du-Rhone, France
C.H.R.U. de Brest - Hopital Morvan ( Site 0806), Brest, Bretagne, France
Centre Hospitalier Annecy Genevois ( Site 0811), Epagny Metz Tessy, Haute-Savoie, France
Clinique Teissier Groupe ( Site 0808), Valenciennes, Nord, France
Hopital Avicenne ( Site 0803), Bobigny, Seine-Saint-Denis, France
Clinique de l'Europe-Service de pneumologie ( Site 0816), Amiens, Somme, France
H.I.A. Sainte-Anne ( Site 0815), Toulon, Var, France
CHD Vendee ( Site 0807), La Roche sur Yon, Vendee, France
UniversitÀtsmedizin Göttingen - Georg-August-UniversitÀt ( Site 0917), Göttingen, Niedersachsen, Germany
Johannes Wesling Klinikum Minden ( Site 0908), Minden, Nordrhein-Westfalen, Germany
GEHO Muenster ( Site 0910), Muenster, Nordrhein-Westfalen, Germany
Johanna Etienne Hospital-Klinik fĂŒr Onkologie ( Site 0916), Neuss, Nordrhein-Westfalen, Germany
LungenClinic Grosshansdorf GmbH ( Site 0901), Grosshansdorf, Schleswig-Holstein, Germany
Zentralklinik Bad Berka GmbH ( Site 0905), Bad Berka, Thuringen, Germany
Universitaetsklinikum Jena ( Site 0911), Jena, Thuringen, Germany
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900), Berlin, , Germany
Katholisches Marienkrankenhaus gGmbH ( Site 0902), Hamburg, , Germany
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302), Kecskemét, Bacs-Kiskun, Hungary
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303), Gyula, Bekes, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 2306), Gyor, Gyor-Moson-Sopron, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 2305), Budapest, , Hungary
OrszĂĄgos KorĂĄnyi PulmonolĂłgiai IntĂ©zet-VI. TĂŒdöbelosztĂĄly Ă©s BroncholĂłgia ( Site 2309), Budapest, , Hungary
Azienda Ospedaliera Umberto I- Torrette ( Site 1009), Torrette, Ancona, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1001), Florence, Firenze, Italy
Istituto Clinico Humanitas Research Hospital ( Site 1000), Rozzano, Lombardia, Italy
Azienda Ospedaliera Vito Fazzi ( Site 1003), Lecce, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008), Milano, , Italy
Policlinico di Modena ( Site 1007), Modena, , Italy
Policlinico Agostino Gemelli ( Site 1002), Roma, , Italy
A.O.U. Santa Maria della Misericordia di Udine ( Site 1004), Udine, , Italy
Kurume University Hospital ( Site 3112), Kurume, Fukuoka, Japan
Kobe Minimally Invasive Cancer Center ( Site 3100), Kobe, Hyogo, Japan
Kanagawa Cancer Center ( Site 3101), Yokohama, Kanagawa, Japan
Kansai Medical University Hospital ( Site 3103), Hirakata, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 3110), Takatsuki, Osaka, Japan
National Hospital Organization Kyushu Cancer Center ( Site 3104), Fukuoka, , Japan
Niigata Cancer Center Hospital ( Site 3109), Niigata, , Japan
Osaka International Cancer Institute ( Site 3106), Osaka, , Japan
Juntendo University Hospital ( Site 3111), Tokyo, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 3108), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 3107), Tokyo, , Japan
Showa University Hospital ( Site 3105), Tokyo, , Japan
Chungbuk National University Hospital ( Site 2802), Cheongju-si, Chungbuk, Korea, Republic of
National Cancer Center ( Site 2800), Goyang-si, Kyonggi-do, Korea, Republic of
The Catholic University of Korea St. Vincent s Hospital ( Site 2805), Gyeonggi-do, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 2801), Seongnam-si, Kyonggi-do, Korea, Republic of
Ajou University Hospital ( Site 2803), Suwon-si, Kyonggi-do, Korea, Republic of
Gyeongsang National University Hospital ( Site 2804), Jinju-si, Kyongsangnam-do, Korea, Republic of
Keimyung University Dongsan Hospital ( Site 2807), Daegu, Taegu-Kwangyokshi, Korea, Republic of
Kangbuk Samsung Hospital ( Site 2806), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 2808), Seoul, , Korea, Republic of
Pauls Stradins Clinical University Hospital ( Site 1501), Riga, , Latvia
Riga East Clinical University Hospital ( Site 1500), Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201), Kaunas, Kauno Apskritis, Lithuania
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200), Vilnius, Vilniaus Miestas, Lithuania
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500), Guadalajara, Jalisco, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508), Monterrey, Nuevo Leon, Mexico
CLIMERS Clinical Medical Research ( Site 0506), Orizaba, Veracruz, Mexico
Instituto Nacional de Cancerologia ( Site 0502), Tlalpan, , Mexico
Akershus Universitetssykehus HF ( Site 1106), Lorenskog, Akershus, Norway
Vestre Viken HF Drammen Sykehus ( Site 1101), Drammen, Buskerud, Norway
Sykehuset Oestfold ( Site 1107), Gralum, Ostfold, Norway
Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103), Stavanger, Rogaland, Norway
Oslo Universitetssykehus HF. Ulleval ( Site 1100), Oslo, , Norway
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604), Arequipa, Ariqipa, Peru
Oncosalud ( Site 0605), Lima, Muni Metro De Lima, Peru
Detecta ClĂnica ( Site 0607), Surquillo, Muni Metro De Lima, Peru
IPOR Instituto Peruano de OncologĂa & Radioterapia ( Site 0606), Lima, , Peru
Clinica San Gabriel ( Site 0601), Lima, , Peru
Hospital Nacional Cayetano Heredia ( Site 0602), Lima, , Peru
Mazowiecki Szpital WojewĂłdzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404), Siedlce, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400), Gdynia, Pomorskie, Poland
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401), Olsztyn, Warminsko-mazurskie, Poland
Spitalul Universitar de Urgenta Bucuresti ( Site 2508), Bucharest, Bucuresti, Romania
Gral Medical SRL-Medical Oncology ( Site 2511), BucureÈti, Bucuresti, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506), Cluj Napoca, Cluj, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 2503), Comuna Floresti, Cluj, Romania
Centrul de Oncologie "SfĂąntul Nectarie"-Medical Oncology ( Site 2510), Craiova, Dolj, Romania
Radiology Therapeutic Center-Oncology ( Site 2502), Otopeni, Ilfov, Romania
Policlinica Oncomed SRL ( Site 2504), Timisoara, Timis, Romania
S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509), TimiÈoara, Timis, Romania
S.C.Focus Lab Plus S.R.L ( Site 2500), Bucuresti, , Romania
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501), Constanta, , Romania
Institutul Regional de Oncologie Iasi ( Site 2505), Iasi, , Romania
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913), Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903), Moscow, Moskva, Russian Federation
Nizhniy Novgorod Region Oncology Dispensary ( Site 1914), Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Medical institute named after Berezin Sergey ( Site 1906), St. Petersburg, Sankt-Peterburg, Russian Federation
Sverdlovsk Regional Oncology Hospital ( Site 1909), Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911), Kazan, Tatarstan, Respublika, Russian Federation
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910), Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202), Majadahonda, Madrid, Spain
Hospital Universitario Quiron Madrid ( Site 1200), Pozuelo de Alarcon, Madrid, Spain
H.R.U MĂĄlaga - Hospital General ( Site 1206), MĂĄlaga, Malaga, Spain
H.U. Vall de Hebron ( Site 1201), Barcelona, , Spain
Hospital Clinic de Barcelona ( Site 1204), Barcelona, , Spain
Hospital Universitario Virgen Macarena ( Site 1205), Sevilla, , Spain
Hospital Universitario La Fe ( Site 1203), Valencia, , Spain
Chulalongkorn University ( Site 3003), Bangkok, Krung Thep Maha Nakhon, Thailand
Ramathibodi Hospital. ( Site 3000), Bangkok, Krung Thep Maha Nakhon, Thailand
Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001), Chiang Mai, , Thailand
Srinagarind Hospital. Khon Kaen University ( Site 3002), Khon Kaen, , Thailand
Ankara Bilkent Sehir Hastanesi ( Site 2002), Ankara, Adana, Turkey
Memorial Ankara Hastanesi ( Site 2006), Ankara, , Turkey
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000), Istanbul, , Turkey
Medipol Universite Hastanesi ( Site 2003), Istanbul, , Turkey
Göztepe Prof. Dr. SĂŒleyman Yalçın Ćehir Hastanesi-oncology ( Site 2001), Istanbul, , Turkey
Ege University Medical Faculty ( Site 2005), Izmir, , Turkey
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107), Dnipro, Dnipropetrovska Oblast, Ukraine
SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (, Kharkiv, Kharkivska Oblast, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (, Antonivka Village, Khersonska Oblast, Ukraine
LLC Ukrainian Center of Tomotherapy ( Site 2105), Kropyvnytskyi, Kirovohradska Oblast, Ukraine
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104), Kapitanivka Village, Kyivska Oblast, Ukraine
SNPE National Cancer Institute ( Site 2101), Kyiv, Kyivska Oblast, Ukraine
Medical Center Verum ( Site 2106), Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 2100), Kyiv, , Ukraine
Weston Park Hospital ( Site 1406), Sheffield, Derbyshire, United Kingdom
University College Hospital NHS Foundation Trust ( Site 1403), London-Camden, London, City Of, United Kingdom
Guys and St Thomas NHS Foundation Trust ( Site 1410), London, London, City Of, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 1407), London, Surrey, United Kingdom
Southampton General Hospital ( Site 1400), Southampton, Worcestershire, United Kingdom
Leeds Teaching Hospitals NHS Trust ( Site 1401), Leeds, , United Kingdom
Christie NHS Foundation Trust ( Site 1409), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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