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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
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
Conditions
Interventions
Pembrolizumab 200 mg
Pembrolizumab 200 mg Q3W
Pembrolizumab 400 mg
Pembrolizumab 400 mg Q6W
Pembrolizumab placebo (saline)
Pembrolizumab placebo (saline) Q3W
Pembrolizumab placebo (saline)
Pembrolizumab placebo (saline) Q6W
Olaparib 300 mg BID
Olaparib 300 mg twice daily (BID)
Olaparib matching placebo
Olaparib matching placebo BID
Etoposide 100 mg/m^2
Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3
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
Standard Thoracic Radiotherapy
Standard Thoracic Radiotherapy
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