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ACTIVE NOT RECRUITING
NCT04380636
PHASE3

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

View on ClinicalTrials.gov

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

BIOLOGICAL

Pembrolizumab

intravenous (IV) infusion

DRUG

Olaparib

oral tablets

DRUG

Placebo for olaparib

oral tablets

DRUG

Etoposide

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Cisplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Pemetrexed

IV infusion

RADIATION

Thoracic Radiotherapy

external beam radiation

DRUG

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