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ACTIVE NOT RECRUITING
NCT04624204
PHASE3

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.

Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

672

Start Date

2020-12-08

Completion Date

2027-10-28

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pembrolizumab 200 mg

Pembrolizumab 200 mg Q3W

BIOLOGICAL

Pembrolizumab 400 mg

Pembrolizumab 400 mg Q6W

DRUG

Pembrolizumab placebo (saline)

Pembrolizumab placebo (saline) Q3W

DRUG

Pembrolizumab placebo (saline)

Pembrolizumab placebo (saline) Q6W

DRUG

Olaparib 300 mg BID

Olaparib 300 mg twice daily (BID)

DRUG

Olaparib matching placebo

Olaparib matching placebo BID

DRUG

Etoposide 100 mg/m^2

Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3

DRUG

Platinum, investigator's choice

Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m\^2 IV Q3W on Day 1 of each cycle

RADIATION

Standard Thoracic Radiotherapy

Standard Thoracic Radiotherapy

RADIATION

Prophylactic Cranial Irradiation (PCI)

PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Locations (187)

Ironwood Cancer & Research Centers ( Site 0007)

Chandler, Arizona, United States

Loma Linda University Cancer Center ( Site 0011)

Loma Linda, California, United States

Georgetown University ( Site 0017)

Washington D.C., District of Columbia, United States

Moffitt Cancer Center ( Site 0137)

Tampa, Florida, United States

University of Chicago Medical Center ( Site 0136)

Chicago, Illinois, United States

Fort Wayne Medical Oncology and Hematology ( Site 0034)

Fort Wayne, Indiana, United States

University of Kentucky Chandler Medical Center ( Site 0138)

Lexington, Kentucky, United States

Overton Brooks VAMC ( Site 0041)

Shreveport, Louisiana, United States

Harry & Jeanette Weinberg Cancer Institute ( Site 0045)

Baltimore, Maryland, United States

VA Ann Arbor Healthcare System ( Site 0050)

Ann Arbor, Michigan, United States

St. Vincent Healthcare Frontier Cancer Center ( Site 0056)

Billings, Montana, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)

Omaha, Nebraska, United States

Memorial Sloan Kettering - Basking Ridge ( Site 0133)

Basking Ridge, New Jersey, United States

John Theurer Cancer Center ( Site 0064)

Hackensack, New Jersey, United States

Memorial Sloan Kettering - Monmouth ( Site 0135)

Middletown, New Jersey, United States

Memorial Sloan Kettering - Bergen ( Site 0130)

Montvale, New Jersey, United States

Rutgers Cancer Institute of New Jersey ( Site 0123)

New Brunswick, New Jersey, United States

Memorial Sloan Kettering- Commack ( Site 0132)

Commack, New York, United States

Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0069)

New York, New York, United States

Memorial Sloan Kettering - Nassau ( Site 0131)

Uniondale, New York, United States

Fairview Hospital-Moll Cancer Center ( Site 0141)

Cleveland, Ohio, United States

Cleveland Clinic Main ( Site 0139)

Cleveland, Ohio, United States

Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)

Mayfield Heights, Ohio, United States

Penn State Hershey Cancer Institute ( Site 0081)

Hershey, Pennsylvania, United States

Saint Francis Cancer Center ( Site 0087)

Greenville, South Carolina, United States

The University of Tennessee Medical Center ( Site 0116)

Knoxville, Tennessee, United States

Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)

Dallas, Texas, United States

Texas Oncology - Dallas (Sammons) ( Site 0093)

Dallas, Texas, United States

MD Anderson Cancer Center ( Site 0100)

Houston, Texas, United States

Millennium Research & Clinical Development ( Site 0143)

Houston, Texas, United States

Providence Regional Cancer Partnership ( Site 0106)

Everett, Washington, United States

Medical Oncology Associates, PS ( Site 0142)

Spokane, Washington, United States

Multicare Institute For Research And Innovation ( Site 0108)

Tacoma, Washington, United States

Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)

Yakima, Washington, United States

Campbelltown Hospital ( Site 3002)

Campbelltown, New South Wales, Australia

Nepean Hospital ( Site 3001)

Kingswood, New South Wales, Australia

Calvary Mater Newcastle ( Site 3000)

Waratah, New South Wales, Australia

Gold Coast University Hospital ( Site 3003)

Southport, Queensland, Australia

Frankston Hospital-Oncology and Haematology ( Site 3007)

Frankston, Victoria, Australia

Austin Health-Austin Hospital ( Site 3006)

Heidelberg, Victoria, Australia

Western Health-Sunshine Hospital ( Site 3004)

St Albans, Victoria, Australia

Saint-Luc UCL ( Site 1005)

Brussels, Bruxelles-Capitale, Region de, Belgium

Grand Hopital de Charleroi ( Site 1003)

Gilly, Hainaut, Belgium

C.I.U. Hopital Ambroise Pare ( Site 1001)

Mons, Hainaut, Belgium

CHU UCL Namur Site de Godinne ( Site 1004)

Yvoir, Namur, Belgium

UZ Leuven ( Site 1002)

Leuven, Vlaams-Brabant, Belgium

AZ Delta ( Site 1000)

Roeselare, West-Vlaanderen, Belgium

MHAT "Uni Hospital" OOD ( Site 2507)

Panagyurishte, Pazardzhik, Bulgaria

Cross Cancer Institute ( Site 0206)

Edmonton, Alberta, Canada

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)

Hamilton, Ontario, Canada

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0210)

Montreal, Quebec, Canada

CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)

Trois-Rivières, Quebec, Canada

Peking Union Medical College Hospital ( Site 3102)

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)

Beijing, Beijing Municipality, China

Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)

Beijing, Beijing Municipality, China

Beijing Cancer Hospital ( Site 3127)

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital ( Site 3135)

Chongqing, Chongqing Municipality, China

Daping Hospital,Third Military Medical University ( Site 3136)

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital ( Site 3126)

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University ( Site 3121)

Xiamen, Fujian, China

Peking University Shenzhen Hospital ( Site 3118)

Shenzhen, Guangdong, China

Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)

Shenzhen, Guangdong, China

Henan Cancer Hospital ( Site 3105)

Zhengzhou, Henan, China

Tongji Medical College Huazhong University of Science and Technology ( Site 3138)

Wuhan, Hubei, China

Union Hospital, Tongji Medical College of HUST ( Site 3123)

Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 3120)

Wuhan, Hubei, China

Xiangya Hospital of Central South University ( Site 3137)

Changsha, Hunan, China

Second Xiangya Hospital of Central-South University ( Site 3128)

Changsha, Hunan, China

Hunan Cancer Hospital ( Site 3133)

Changsha, Hunan, China

Jiangsu Cancer Hospital ( Site 3139)

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University ( Site 3106)

Nanchang, Jiangxi, China

The First Hospital of Jilin University ( Site 3132)

Changchun, Jilin, China

Affiliated Cancer Hospital of Shandong First Medical University ( Site 3100)

Jinan, Shandong, China

Shanghai Chest Hospital ( Site 3107)

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital ( Site 3101)

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University ( Site 3114)

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital ( Site 3103)

Tianjin, Tianjin Municipality, China

Hangzhou Cancer Hospital ( Site 3129)

Hanghzou, Zhejiang, China

The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 3108)

Hangzhou, Zhejiang, China

SA Pohja-Eesti Regionaalhaigla ( Site 2201)

Tallinn, Harju, Estonia

SA Tartu Ulikooli Kliinikum ( Site 2200)

Tartu, Tartu, Estonia

C.H. de Saint Quentin ( Site 1111)

Saint-Quentin, Aisne, France

CHU de Bordeaux Hop St ANDRE ( Site 1115)

Bordeaux, Aquitaine, France

Clinique Clairval ( Site 1108)

Marseille, Bouches-du-Rhone, France

CHU Grenoble -Hop Michallon ( Site 1102)

Grenoble, Isere, France

Institut De Cancerologie De L Ouest ( Site 1110)

Saint-Herblain, Loire-Atlantique, France

Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)

Angers, Maine-et-Loire, France

Hopital Avicenne ( Site 1106)

Bobigny, Seine-Saint-Denis, France

H.I.A. Sainte-Anne ( Site 1101)

Toulon, Var, France

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)

Paris, Île-de-France Region, France

Henry Dunant Hospital ( Site 1205)

Athens, Attica, Greece

Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)

Athens, Attica, Greece

Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)

Thessaloniki, Central Macedonia, Greece

University General Hospital of Herakleion ( Site 1202)

Heraklion, Irakleio, Greece

University General Hospital of Larisa ( Site 1201)

Larissa, Thessaly, Greece

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)

Kecskemét, Bács-Kiskun county, Hungary

Petz Aladar Megyei Oktato Korhaz ( Site 1312)

Győr, Győr-Moson-Sopron, Hungary

Reformatus Pulmonologiai Centrum ( Site 1304)

Törökbálint, Pest County, Hungary

Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)

Budapest, Hungary

Orszagos Onkologiai Intezet ( Site 1310)

Budapest, Hungary

Uzsoki Utcai Korhaz ( Site 1303)

Budapest, Hungary

Rambam Health Care Campus-Oncology Division ( Site 1401)

Haifa, Israel

Chaim Sheba Medical Center ( Site 1400)

Ramat Gan, Israel

A O U Policlinico di Modena ( Site 1503)

Modena, Emilia-Romagna, Italy

Azienda Ospedaliero Universitaria Careggi ( Site 1509)

Florence, Firenze, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 1513)

Verona, Veneto, Italy

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)

Brescia, Italy

IRCCS Ospedale San Raffaele ( Site 1500)

Milan, Italy

Istituto Nazionale dei Tumori ( Site 1504)

Milan, Italy

Istituto Europeo di Oncologia ( Site 1501)

Milan, Italy

IRCCS Istituto Oncologico Veneto ( Site 1506)

Padova, Italy

Policlinico Universitario Agostino Gemelli ( Site 1505)

Roma, Italy

Aichi Cancer Center ( Site 4010)

Nagoya, Aichi-ken, Japan

Kobe Minimally Invasive Cancer Center ( Site 4003)

Kobe, Hyōgo, Japan

Takarazuka City Hospital ( Site 4013)

Takarazuka, Hyōgo, Japan

Kanagawa Cancer Center ( Site 4001)

Yokohama, Kanagawa, Japan

Kansai Medical University Hospital ( Site 4009)

Hirakata, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital ( Site 4007)

Takatsuki, Osaka, Japan

Shizuoka Cancer Center ( Site 4014)

Nakatogari, Shizuoka, Japan

National Hospital Organization Kyushu Cancer Center ( Site 4000)

Fukuoka, Japan

Niigata Cancer Center Hospital ( Site 4004)

Niigata, Japan

Okayama University Hospital ( Site 4012)

Okayama, Japan

Osaka International Cancer Institute ( Site 4005)

Osaka, Japan

National Cancer Center Hospital ( Site 4015)

Tokyo, Japan

Juntendo University Hospital ( Site 4008)

Tokyo, Japan

Tokyo Metropolitan Komagome Hospital ( Site 4011)

Tokyo, Japan

Cancer Institute Hospital of JFCR ( Site 4006)

Tokyo, Japan

Showa Medical University Hospital ( Site 4002)

Tokyo, Japan

Nacionalinis Vezio Institutas ( Site 2300)

Vilnius, Vilniaus Miestas, Lithuania

LSMUL Kauno Klinikos ( Site 2301)

Kaunas, Lithuania

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)

Guadalajara, Jalisco, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)

Monterrey, Nuevo León, Mexico

Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 1704)

Lisbon, Lisbon District, Portugal

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)

Lisbon, Portugal

Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)

Porto, Portugal

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)

Cluj-Napoca, Cluj, Romania

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)

Florești, Cluj, Romania

Spitalul Municipal Ploiesti ( Site 2801)

Ploieşti, Prahova, Romania

Cabinet Medical Oncomed ( Site 2802)

Timișoara, Timiș County, Romania

S.C.Focus Lab Plus S.R.L ( Site 2804)

Bucharest, Romania

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)

Moscow, Moscow, Russia

MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)

Moscow, Moscow, Russia

Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)

Balashikha, Moscow Oblast, Russia

Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Omsk Clinical Oncology Dispensary ( Site 1806)

Omsk, Omsk Oblast, Russia

Sverdlovsk Regional Oncology Hospital ( Site 1807)

Yekaterinburg, Sverdlovsk Oblast, Russia

Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)

Kazan', Tatarstan, Respublika, Russia

Institute for Oncology and Radiology of Serbia ( Site 2995)

Belgrade, Beograd, Serbia

Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)

Kamenitz, Sremski Okrug, Serbia

Steve Biko Academic Hospital ( Site 5000)

Pretoria, Gauteng, South Africa

Groote Schuur Hospital ( Site 5002)

Cape Town, Western Cape, South Africa

National Cancer Center ( Site 3306)

Goyang-si, Kyonggi-do, South Korea

Seoul National University Bundang Hospital ( Site 3301)

Seongnam-si, Kyonggi-do, South Korea

The Catholic University of Korea St. Vincent s Hospital ( Site 3303)

Suwon, Kyonggi-do, South Korea

Inje University Haeundae Paik Hospital ( Site 3307)

Busan, Pusan-Kwangyokshi, South Korea

Asan Medical Center ( Site 3308)

Songpagu, Seoul, South Korea

Keimyung University Dongsan Hospital CRC room 1 ( Site 3302)

Daegu, Taegu-Kwangyokshi, South Korea

Severance Hospital Yonsei University Health System ( Site 3304)

Seoul, South Korea

Samsung Medical Center ( Site 3300)

Seoul, South Korea

Hospital Duran i Reynals ( Site 1903)

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Central de Asturias ( Site 1900)

Oviedo, Principality of Asturias, Spain

Hospital Universitari Vall d Hebron ( Site 1904)

Barcelona, Spain

Hospital Universitario 12 de Octubre ( Site 1902)

Madrid, Spain

Hospital Regional Universitario de Malaga ( Site 1905)

Málaga, Spain

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)

Seville, Spain

Ankara Bilkent Sehir Hastanesi ( Site 2007)

Ankara, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)

Istanbul, Turkey (Türkiye)

Medipol Universite Hastanesi ( Site 2005)

Istanbul, Turkey (Türkiye)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)

Istanbul, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

Izmir, Turkey (Türkiye)

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Municipal non-profit Enterprise "Khmelnytskyi Regional Antitumor Center" ( Site 2115)

Khmelnytskyi, Khmelnytskyi Oblast, Ukraine

LISOD. Hospital ( Site 2111)

Pliuty, Kyiv Oblast, Ukraine

Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

Kapitanivka Village, Kyivska Oblast, Ukraine

Clinic of National Cancer Institute ( Site 2101)

Kyiv, Kyivska Oblast, Ukraine

Medical Center Verum ( Site 2106)

Kyiv, Kyivska Oblast, Ukraine

Communal Noncommercial Enterprise "Podillia Regional Oncolog-Chemotherapy Department ( Site 2114)

Vinnytsia, Vinnytsia Oblast, Ukraine

Kyiv City Clinical Oncology Center ( Site 2100)

Kyiv, Ukraine

Royal Infirmary Aberdeen ( Site 2403)

Aberdeen, Aberdeen City, United Kingdom

Ninewells Hospital and Medical School ( Site 2401)

Dundee, Dundee City, United Kingdom

Taunton and Somerset Hospital ( Site 2404)

Taunton, England, United Kingdom

Barts Health NHS Trust ( Site 2409)

London, London, City of, United Kingdom

Guy s & St Thomas NHS Foundation Trust ( Site 2408)

London, London, City of, United Kingdom

The Christie NHS Foundation Trust ( Site 2405)

Manchester, United Kingdom