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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)
Sponsor: Merck Sharp & Dohme LLC
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
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
870
Start Date
2020-07-06
Completion Date
2027-02-15
Last Updated
2025-08-17
Healthy Volunteers
No
Interventions
Pembrolizumab
intravenous (IV) infusion
Olaparib
oral tablets
Placebo for olaparib
oral tablets
Etoposide
IV infusion
Carboplatin
IV infusion
Cisplatin
IV infusion
Paclitaxel
IV infusion
Pemetrexed
IV infusion
Thoracic Radiotherapy
external beam radiation
Durvalumab
IV infusion
Locations (205)
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)
St Louis, Missouri, United States
Washington University Siteman Cancer Center ( Site 0046)
St 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
Valley Health Systems - Ridgewood Campus ( Site 0056)
Paramus, New Jersey, United States
Montefiore Einstein Center ( Site 0083)
The 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
Clinica Adventista Belgrano-Oncology ( Site 4002)
Caba., Buenos Aires, Argentina
Instituto Médico Río Cuarto ( Site 4003)
Río Cuarto, Córdoba Province, 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, Hôpital de l'Enfant-Jésus ( Site 0110)
Québec, Quebec, Canada
OrlandiOncologia ( Site 0201)
Providencia, Region M. de Santiago, Chile
Bradfordhill ( Site 0200)
Santiago, Region M. de Santiago, Chile
Centro Investigación del Cáncer James Lind ( Site 0202)
Temuco, Región de la Araucanía, Chile
Oncocentro ( Site 0203)
Viña del Mar, Región de Valparaíso, Chile
Bradford Hill Norte ( Site 0204)
Antofagasta, Chile
Peking Union Medical College Hospital ( Site 3201)
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)
Beijing, Beijing Municipality, China
Beijing Cancer Hospital ( Site 3212)
Beijing, Beijing Municipality, China
Beijing Cancer Hospital ( Site 3224)
Beijing, Beijing Municipality, China
Daping Hospital,Third Military Medical University ( Site 3235)
Chongqing, Chongqing Municipality, 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 Cancer Center ( Site 3222)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 3218)
Wuhan, Hubei, 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
Hunan Cancer Hospital ( Site 3238)
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)
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University ( Site 3220)
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital ( Site 3203)
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University ( Site 3202)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 3204)
Tianjin, Tianjin Municipality, 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)
Prague, Praha 5, Czechia
Nemocnice Na Plesi s.r.o. ( Site 2202)
Nová Ves pod Pleší, Pribram, Czechia
Krajska nemocnice Liberec, a.s. ( Site 2209)
Liberec, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 2208)
Prague, Czechia
Nemocnice Na Bulovce ( Site 2205)
Prague, Czechia
North Estonia Medical Centre Foundation ( Site 1601)
Tallinn, Harju, Estonia
Tartu University Hospital ( Site 1600)
Tartu, Tartu, Estonia
Clinique Clairval ( Site 0802)
Marseille, Bouches-du-Rhone, France
C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 0806)
Brest, Brittany Region, 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
Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917)
Göttingen, Lower Saxony, Germany
Johannes Wesling Klinikum Minden ( Site 0908)
Minden, North Rhine-Westphalia, Germany
GEHO Muenster ( Site 0910)
Münster, North Rhine-Westphalia, Germany
Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)
Neuss, North Rhine-Westphalia, Germany
LungenClinic Grosshansdorf GmbH ( Site 0901)
Großhansdorf, Schleswig-Holstein, Germany
Zentralklinik Bad Berka GmbH ( Site 0905)
Bad Berka, Thuringia, Germany
Universitaetsklinikum Jena ( Site 0911)
Jena, Thuringia, Germany
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)
Berlin, Germany
Katholisches Marienkrankenhaus gGmbH ( Site 0902)
Hamburg, Germany
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)
Gyula, Bekes County, Hungary
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)
Kecskemét, Bács-Kiskun county, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 2306)
Győr, Győr-Moson-Sopron, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)
Budapest, Hungary
Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)
Budapest, Hungary
Azienda Ospedaliera Umberto I- Torrette ( Site 1009)
Torrette, Ancona, Italy
Policlinico Agostino Gemelli ( Site 1002)
Rome, Lazio, Italy
Istituto Clinico Humanitas Research Hospital ( Site 1000)
Rozzano, Lombardy, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1001)
Florence, Italy
Azienda Ospedaliera Vito Fazzi ( Site 1003)
Lecce, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)
Milan, Italy
Policlinico di Modena ( Site 1007)
Modena, 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, Hyōgo, 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
Cancer Institute Hospital of JFCR ( Site 3107)
Tokyo, Japan
Showa Medical University Hospital ( Site 3105)
Tokyo, Japan
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, Kaunas County, 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 León, 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
Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)
Stavanger, Rogaland, Norway
Oslo Universitetssykehus HF. Ulleval ( Site 1100)
Oslo, Norway
Sykehuset Oestfold ( Site 1107)
Grålum, Østfold fylke, Norway
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)
Arequipa, Ariqipa, Peru
Detecta Clínica ( Site 0607)
Surquillo, Muni Metro de Lima, Peru
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606)
Lima, Peru
Oncosalud ( Site 0605)
Lima, Peru
Clinica San Gabriel ( Site 0601)
Lima, Peru
Hospital Nacional Cayetano Heredia ( Site 0602)
Lima, Peru
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404)
Siedlce, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2402)
Warsaw, Masovian Voivodeship, Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)
Gdynia, Pomeranian Voivodeship, Poland
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)
Olsztyn, Warmian-Masurian Voivodeship, Poland
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2500)
Bucharest, București, Romania
Gral Medical SRL-Medical Oncology ( Site 2511)
Bucharest, București, Romania
Spitalul Universitar de Urgenta Bucuresti ( Site 2508)
Bucharest, București, 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 Sfantul Nectarie-Medical ( Site 2510)
Craiova, Dolj, Romania
Radiology Therapeutic Center-Oncology ( Site 2502)
Otopeni, Ilfov, Romania
S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)
Timișoara, Timiș County, Romania
Policlinica Oncomed SRL ( Site 2504)
Timișoara, Timiș County, Romania
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)
Constanța, Romania
Institutul Regional de Oncologie Iasi ( Site 2505)
Iași, Romania
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)
Chelyabinsk, Chelyabinsk Oblast, Russia
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)
Moscow, Moscow, Russia
Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Medical institute named after Berezin Sergey ( Site 1906)
Saint Petersburg, Sankt-Peterburg, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)
Saint Petersburg, Sankt-Peterburg, Russia
Sverdlovsk Regional Oncology Hospital ( Site 1909)
Yekaterinburg, Sverdlovsk Oblast, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1911)
Kazan', Tatarstan, Respublika, Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)
Yaroslavl, Yaroslavl Oblast, Russia
National Cancer Center ( Site 2800)
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 2801)
Seongnam-si, Kyonggi-do, South Korea
The Catholic University of Korea St. Vincent s Hospital ( Site 2805)
Suwon, Kyonggi-do, South Korea
Ajou University Hospital ( Site 2803)
Suwon, Kyonggi-do, South Korea
Gyeongsang National University Hospital ( Site 2804)
Jinju, Kyongsangnam-do, South Korea
Chungbuk National University Hospital ( Site 2802)
Cheongju-si, North Chungcheong, South Korea
Keimyung University Dongsan Hospital CRC room 1 ( Site 2807)
Daegu, Taegu-Kwangyokshi, South Korea
Kangbuk Samsung Hospital ( Site 2806)
Seoul, South Korea
Severance Hospital Yonsei University Health System ( Site 2808)
Seoul, South Korea
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)
Majadahonda, Madrid, Spain
Hospital Universitario Quiron Madrid ( Site 1200)
Pozuelo de Alarcón, Madrid, Spain
H.R.U Malaga - Hospital General ( Site 1206)
Málaga, 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)
Seville, Spain
Hospital Universitario La Fe ( Site 1203)
Valencia, Spain
Chulalongkorn University ( Site 3003)
Bangkok, Bangkok, Thailand
Ramathibodi Hospital. ( Site 3000)
Bangkok, Bangkok, 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 (Türkiye)
Memorial Ankara Hastanesi ( Site 2006)
Ankara, Turkey (Türkiye)
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)
Istanbul, Turkey (Türkiye)
Medipol Universite Hastanesi ( Site 2003)
Istanbul, Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)
Istanbul, Turkey (Türkiye)
Ege University Medical Faculty ( Site 2005)
Izmir, Turkey (Türkiye)
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
Dnipro, Dnipropetrovsk Oblast, Ukraine
SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology ( Site 2110)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council ( Site 2109)
Antonivka Village, Kherson Oblast, Ukraine
LLC Ukrainian Center of Tomotherapy ( Site 2105)
Kropyvnytskyi, Kirovohrad 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
Guys and St Thomas NHS Foundation Trust ( Site 1410)
London, London, City of, United Kingdom
University College Hospital NHS Foundation Trust ( Site 1403)
London-Camden, 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