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)

September 7, 2026 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Small Cell Lung Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

672

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Campbelltown, New South Wales, Australia, 2560
    - Campbelltown Hospital ( Site 3002)
  - Kingswood, New South Wales, Australia, 2747
    - Nepean Hospital ( Site 3001)
  - Waratah, New South Wales, Australia, 2298
    - Calvary Mater Newcastle ( Site 3000)
- Queensland
  - Southport, Queensland, Australia, 4215
    - Gold Coast University Hospital ( Site 3003)
- Victoria
  - Frankston, Victoria, Australia, 3199
    - Frankston Hospital-Oncology and Haematology ( Site 3007)
  - Heidelberg, Victoria, Australia, 3084
    - Austin Health-Austin Hospital ( Site 3006)
  - St Albans, Victoria, Australia, 3021
    - Western Health-Sunshine Hospital ( Site 3004)
Belgium
- Bruxelles-Capitale, Region de
  - Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
    - Saint-Luc UCL ( Site 1005)
- Hainaut
  - Gilly, Hainaut, Belgium, 6060
    - Grand Hopital de Charleroi ( Site 1003)
  - Mons, Hainaut, Belgium, 7000
    - C.I.U. Hopital Ambroise Pare ( Site 1001)
- Namur
  - Yvoir, Namur, Belgium, 5530
    - CHU UCL Namur Site de Godinne ( Site 1004)
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - UZ Leuven ( Site 1002)
- West-Vlaanderen
  - Roeselare, West-Vlaanderen, Belgium, 8800
    - AZ Delta ( Site 1000)
Bulgaria
- Pazardzhik
  - Panagyurishte, Pazardzhik, Bulgaria, 4500
    - MHAT "Uni Hospital" OOD ( Site 2507)
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute ( Site 0206)
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre ( Site 0210)
  - Montreal, Quebec, Canada, H3T 1M5
    - CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)
  - Trois-Rivières, Quebec, Canada, G8Z 3R9
    - CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100006
    - Peking Union Medical College Hospital ( Site 3102)
  - Beijing, Beijing Municipality, China, 100021
    - Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)
  - Beijing, Beijing Municipality, China, 100142
    - Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)
  - Beijing, Beijing Municipality, China, 130021
    - Beijing Cancer Hospital ( Site 3127)
- Chongqing Municipality
  - Chongqing, Chongqing Municipality, China, 400030
    - Chongqing Cancer Hospital ( Site 3135)
  - Chongqing, Chongqing Municipality, China, 400042
    - Daping Hospital,Third Military Medical University ( Site 3136)
- Fujian
  - Fuzhou, Fujian, China, 350014
    - Fujian Provincial Cancer Hospital ( Site 3126)
  - Xiamen, Fujian, China, 361003
    - The First Affiliated Hospital of Xiamen University ( Site 3121)
- Guangdong
  - Shenzhen, Guangdong, China, 518036
    - Peking University Shenzhen Hospital ( Site 3118)
  - Shenzhen, Guangdong, China, 518116
    - Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)
- Henan
  - Zhengzhou, Henan, China, 450008
    - Henan Cancer Hospital ( Site 3105)
- Hubei
  - Wuhan, Hubei, China, 430030
    - Tongji Medical College Huazhong University of Science and Technology ( Site 3138)
  - Wuhan, Hubei, China, 430079
    - Hubei Cancer Hospital ( Site 3120)
  - Wuhan, Hubei, China, 430048
    - Union Hospital, Tongji Medical College of HUST ( Site 3123)
- Hunan
  - Changsha, Hunan, China, 410008
    - Xiangya Hospital of Central South University ( Site 3137)
  - Changsha, Hunan, China, 410011
    - Second Xiangya Hospital of Central-South University ( Site 3128)
  - Changsha, Hunan, China, 410013
    - Hunan Cancer Hospital ( Site 3133)
- Jiangsu
  - Nanjing, Jiangsu, China, 210000
    - Jiangsu Cancer Hospital ( Site 3139)
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - The Second Affiliated Hospital of Nanchang University ( Site 3106)
- Jilin
  - Changchun, Jilin, China, 130021
    - The First Hospital of Jilin University ( Site 3132)
- Shandong
  - Jinan, Shandong, China, 250117
    - Affiliated Cancer Hospital of Shandong First Medical University ( Site 3100)
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200030
    - Shanghai Chest Hospital ( Site 3107)
  - Shanghai, Shanghai Municipality, China, 200443
    - Shanghai Pulmonary Hospital ( Site 3101)
- Sichuan
  - Chengdu, Sichuan, China, 510115
    - West China Hospital of Sichuan University ( Site 3114)
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, China, 300060
    - Tianjin Medical University Cancer Institute & Hospital ( Site 3103)
- Zhejiang
  - Hanghzou, Zhejiang, China, 310002
    - Hangzhou Cancer Hospital ( Site 3129)
  - Hangzhou, Zhejiang, China, 310003
    - The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)
  - Hangzhou, Zhejiang, China, 310022
    - Zhejiang Cancer Hospital ( Site 3108)
Estonia
- Harju
  - Tallinn, Harju, Estonia, 13419
    - SA Pohja-Eesti Regionaalhaigla ( Site 2201)
- Tartu
  - Tartu, Tartu, Estonia, 50406
    - SA Tartu Ulikooli Kliinikum ( Site 2200)
France
- Aisne
  - Saint-Quentin, Aisne, France, 02321
    - C.H. de Saint Quentin ( Site 1111)
- Aquitaine
  - Bordeaux, Aquitaine, France, 33075
    - CHU de Bordeaux Hop St ANDRE ( Site 1115)
- Bouches-du-Rhone
  - Marseille, Bouches-du-Rhone, France, 13009
    - Clinique Clairval ( Site 1108)
- Isere
  - Grenoble, Isere, France, 38043
    - CHU Grenoble -Hop Michallon ( Site 1102)
- Loire-Atlantique
  - Saint-Herblain, Loire-Atlantique, France, 44805
    - Institut De Cancerologie De L Ouest ( Site 1110)
- Maine-et-Loire
  - Angers, Maine-et-Loire, France, 49000
    - Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)
- Seine-Saint-Denis
  - Bobigny, Seine-Saint-Denis, France, 93000
    - Hopital Avicenne ( Site 1106)
- Var
  - Toulon, Var, France, 83800
    - H.I.A. Sainte-Anne ( Site 1101)
- Île-de-France Region
  - Paris, Île-de-France Region, France, 75014
    - Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)
Greece
- Attica
  - Athens, Attica, Greece, 115 26
    - Henry Dunant Hospital ( Site 1205)
  - Athens, Attica, Greece, 115 27
    - Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)
- Central Macedonia
  - Thessaloniki, Central Macedonia, Greece, 54007
    - Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)
- Irakleio
  - Heraklion, Irakleio, Greece, 711 10
    - University General Hospital of Herakleion ( Site 1202)
- Thessaly
  - Larissa, Thessaly, Greece, 411 10
    - University General Hospital of Larisa ( Site 1201)
Hungary
- - Budapest, Hungary, 1121
    - Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)
  - Budapest, Hungary, 1122
    - Orszagos Onkologiai Intezet ( Site 1310)
  - Budapest, Hungary, 1145
    - Uzsoki Utcai Korhaz ( Site 1303)
- Bács-Kiskun county
  - Kecskemét, Bács-Kiskun county, Hungary, 6000
    - Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)
- Győr-Moson-Sopron
  - Győr, Győr-Moson-Sopron, Hungary, 9024
    - Petz Aladar Megyei Oktato Korhaz ( Site 1312)
- Pest County
  - Törökbálint, Pest County, Hungary, 2045
    - Reformatus Pulmonologiai Centrum ( Site 1304)
Israel
- - Haifa, Israel, 3109601
    - Rambam Health Care Campus-Oncology Division ( Site 1401)
  - Ramat Gan, Israel, 5262000
    - Chaim Sheba Medical Center ( Site 1400)
Italy
- - Brescia, Italy, 25123
    - Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)
  - Milan, Italy, 20132
    - IRCCS Ospedale San Raffaele ( Site 1500)
  - Milan, Italy, 20133
    - Istituto Nazionale dei Tumori ( Site 1504)
  - Milan, Italy, 20141
    - Istituto Europeo di Oncologia ( Site 1501)
  - Padova, Italy, 35128
    - IRCCS Istituto Oncologico Veneto ( Site 1506)
  - Roma, Italy, 00168
    - Policlinico Universitario Agostino Gemelli ( Site 1505)
- Emilia-Romagna
  - Modena, Emilia-Romagna, Italy, 41125
    - A O U Policlinico di Modena ( Site 1503)
- Firenze
  - Florence, Firenze, Italy, 50134
    - Azienda Ospedaliero Universitaria Careggi ( Site 1509)
- Veneto
  - Verona, Veneto, Italy, 37126
    - Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 1513)
Japan
- - Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center ( Site 4000)
  - Niigata, Japan, 951-8566
    - Niigata Cancer Center Hospital ( Site 4004)
  - Okayama, Japan, 700-8558
    - Okayama University Hospital ( Site 4012)
  - Osaka, Japan, 541-8567
    - Osaka International Cancer Institute ( Site 4005)
  - Tokyo, Japan, 104-0045
    - National Cancer Center Hospital ( Site 4015)
  - Tokyo, Japan, 113-0033
    - Juntendo University Hospital ( Site 4008)
  - Tokyo, Japan, 113-8677
    - Tokyo Metropolitan Komagome Hospital ( Site 4011)
  - Tokyo, Japan, 135-8550
    - Cancer Institute Hospital of JFCR ( Site 4006)
  - Tokyo, Japan, 142-8666
    - Showa Medical University Hospital ( Site 4002)
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 464-8681
    - Aichi Cancer Center ( Site 4010)
- Hyōgo
  - Kobe, Hyōgo, Japan, 650-0046
    - Kobe Minimally Invasive Cancer Center ( Site 4003)
  - Takarazuka, Hyōgo, Japan, 665-0827
    - Takarazuka City Hospital ( Site 4013)
- Kanagawa
  - Yokohama, Kanagawa, Japan, 241-8515
    - Kanagawa Cancer Center ( Site 4001)
- Osaka
  - Hirakata, Osaka, Japan, 573-1191
    - Kansai Medical University Hospital ( Site 4009)
  - Takatsuki, Osaka, Japan, 569-8686
    - Osaka Medical and Pharmaceutical University Hospital ( Site 4007)
- Shizuoka
  - Nakatogari, Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center ( Site 4014)
Lithuania
- - Kaunas, Lithuania, 50161
    - LSMUL Kauno Klinikos ( Site 2301)
- Vilniaus Miestas
  - Vilnius, Vilniaus Miestas, Lithuania, 08660
    - Nacionalinis Vezio Institutas ( Site 2300)
Mexico
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)
Portugal
- - Lisbon, Portugal, 1099-023
    - Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)
  - Porto, Portugal, 4200-072
    - Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)
- Lisbon District
  - Lisbon, Lisbon District, Portugal, 1769-001
    - Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 1704)
Romania
- - Bucharest, Romania, 022548
    - S.C.Focus Lab Plus S.R.L ( Site 2804)
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400015
    - Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)
  - Florești, Cluj, Romania, 407280
    - Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)
- Prahova
  - Ploieşti, Prahova, Romania, 100337
    - Spitalul Municipal Ploiesti ( Site 2801)
- Timiș County
  - Timișoara, Timiș County, Romania, 300239
    - Cabinet Medical Oncomed ( Site 2802)
Russia
- Moscow
  - Moscow, Moscow, Russia, 105094
    - Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)
  - Moscow, Moscow, Russia, 125284
    - MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)
- Moscow Oblast
  - Balashikha, Moscow Oblast, Russia, 143900
    - Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)
- Nizhny Novgorod Oblast
  - Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603081
    - Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)
- Omsk Oblast
  - Omsk, Omsk Oblast, Russia, 644013
    - Omsk Clinical Oncology Dispensary ( Site 1806)
- Sverdlovsk Oblast
  - Yekaterinburg, Sverdlovsk Oblast, Russia, 620036
    - Sverdlovsk Regional Oncology Hospital ( Site 1807)
- Tatarstan, Respublika
  - Kazan', Tatarstan, Respublika, Russia, 420029
    - Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)
Serbia
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Institute for Oncology and Radiology of Serbia ( Site 2995)
- Sremski Okrug
  - Kamenitz, Sremski Okrug, Serbia, 21204
    - Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)
South Africa
- Gauteng
  - Pretoria, Gauteng, South Africa, 0002
    - Steve Biko Academic Hospital ( Site 5000)
- Western Cape
  - Cape Town, Western Cape, South Africa, 7925
    - Groote Schuur Hospital ( Site 5002)
South Korea
- - Seoul, South Korea, 03722
    - Severance Hospital Yonsei University Health System ( Site 3304)
  - Seoul, South Korea, 06351
    - Samsung Medical Center ( Site 3300)
- Kyonggi-do
  - Goyang-si, Kyonggi-do, South Korea, 10408
    - National Cancer Center ( Site 3306)
  - Seongnam-si, Kyonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital ( Site 3301)
  - Suwon, Kyonggi-do, South Korea, 16247
    - The Catholic University of Korea St. Vincent s Hospital ( Site 3303)
- Pusan-Kwangyokshi
  - Busan, Pusan-Kwangyokshi, South Korea, 48108
    - Inje University Haeundae Paik Hospital ( Site 3307)
- Seoul
  - Songpagu, Seoul, South Korea, 05505
    - Asan Medical Center ( Site 3308)
- Taegu-Kwangyokshi
  - Daegu, Taegu-Kwangyokshi, South Korea, 42601
    - Keimyung University Dongsan Hospital CRC room 1 ( Site 3302)
Spain
- - Barcelona, Spain, 08035
    - Hospital Universitari Vall d Hebron ( Site 1904)
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre ( Site 1902)
  - Málaga, Spain, 29010
    - Hospital Regional Universitario de Malaga ( Site 1905)
  - Seville, Spain, 41009
    - Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    - Hospital Duran i Reynals ( Site 1903)
- Principality of Asturias
  - Oviedo, Principality of Asturias, Spain, 33011
    - Hospital Universitario Central de Asturias ( Site 1900)
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06800
    - Ankara Bilkent Sehir Hastanesi ( Site 2007)
  - Istanbul, Turkey (Türkiye), 34098
    - Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)
  - Istanbul, Turkey (Türkiye), 34214
    - Medipol Universite Hastanesi ( Site 2005)
  - Istanbul, Turkey (Türkiye), 34722
    - Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)
  - Izmir, Turkey (Türkiye), 35040
    - Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
Ukraine
- - Kyiv, Ukraine, 03115
    - Kyiv City Clinical Oncology Center ( Site 2100)
- Kharkiv Oblast
  - Kharkiv, Kharkiv Oblast, Ukraine, 61024
    - Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)
- Khmelnytskyi Oblast
  - Khmelnytskyi, Khmelnytskyi Oblast, Ukraine, 29009
    - Municipal non-profit Enterprise "Khmelnytskyi Regional Antitumor Center" ( Site 2115)
- Kyiv Oblast
  - Pliuty, Kyiv Oblast, Ukraine, 08720
    - LISOD. Hospital ( Site 2111)
- Kyivska Oblast
  - Kapitanivka Village, Kyivska Oblast, Ukraine, 08111
    - Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)
  - Kyiv, Kyivska Oblast, Ukraine, 03039
    - Medical Center Verum ( Site 2106)
  - Kyiv, Kyivska Oblast, Ukraine, 03022
    - Clinic of National Cancer Institute ( Site 2101)
- Vinnytsia Oblast
  - Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
    - Communal Noncommercial Enterprise "Podillia Regional Oncolog-Chemotherapy Department ( Site 2114)
United Kingdom
- - Manchester, United Kingdom, M20 4GJ
    - The Christie NHS Foundation Trust ( Site 2405)
- Aberdeen City
  - Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
    - Royal Infirmary Aberdeen ( Site 2403)
- Dundee City
  - Dundee, Dundee City, United Kingdom, DD1 9SY
    - Ninewells Hospital and Medical School ( Site 2401)
- England
  - Taunton, England, United Kingdom, TA1 5DA
    - Taunton and Somerset Hospital ( Site 2404)
- London, City of
  - London, London, City of, United Kingdom, EC1A 7BE
    - Barts Health NHS Trust ( Site 2409)
  - London, London, City of, United Kingdom, SE1 9RT
    - Guy s & St Thomas NHS Foundation Trust ( Site 2408)
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Ironwood Cancer & Research Centers ( Site 0007)
- California
  - Loma Linda, California, United States, 92350
    - Loma Linda University Cancer Center ( Site 0011)
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Georgetown University ( Site 0017)
- Florida
  - Tampa, Florida, United States, 33612
    - Moffitt Cancer Center ( Site 0137)
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center ( Site 0136)
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - Fort Wayne Medical Oncology and Hematology ( Site 0034)
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky Chandler Medical Center ( Site 0138)
- Louisiana
  - Shreveport, Louisiana, United States, 71101
    - Overton Brooks VAMC ( Site 0041)
- Maryland
  - Baltimore, Maryland, United States, 21237
    - Harry & Jeanette Weinberg Cancer Institute ( Site 0045)
- Michigan
  - Ann Arbor, Michigan, United States, 48105
    - VA Ann Arbor Healthcare System ( Site 0050)
- Montana
  - Billings, Montana, United States, 59102
    - St. Vincent Healthcare Frontier Cancer Center ( Site 0056)
- Nebraska
  - Omaha, Nebraska, United States, 68130
    - Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering - Basking Ridge ( Site 0133)
  - Hackensack, New Jersey, United States, 07601
    - John Theurer Cancer Center ( Site 0064)
  - Middletown, New Jersey, United States, 07748
    - Memorial Sloan Kettering - Monmouth ( Site 0135)
  - Montvale, New Jersey, United States, 07645
    - Memorial Sloan Kettering - Bergen ( Site 0130)
  - New Brunswick, New Jersey, United States, 08901
    - Rutgers Cancer Institute of New Jersey ( Site 0123)
- New York
  - Commack, New York, United States, 11725
    - Memorial Sloan Kettering- Commack ( Site 0132)
  - Harrison, New York, United States, 10604
    - Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)
  - New York, New York, United States, 10021
    - Memorial Sloan Kettering Cancer Center ( Site 0069)
  - Uniondale, New York, United States, 11553
    - Memorial Sloan Kettering - Nassau ( Site 0131)
- Ohio
  - Cleveland, Ohio, United States, 44111
    - Fairview Hospital-Moll Cancer Center ( Site 0141)
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Main ( Site 0139)
  - Mayfield Heights, Ohio, United States, 44124
    - Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Hershey Cancer Institute ( Site 0081)
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Saint Francis Cancer Center ( Site 0087)
- Tennessee
  - Knoxville, Tennessee, United States, 37920
    - The University of Tennessee Medical Center ( Site 0116)
- Texas
  - Dallas, Texas, United States, 75231
    - Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)
  - Dallas, Texas, United States, 75246
    - Texas Oncology - Dallas (Sammons) ( Site 0093)
  - Houston, Texas, United States, 77030
    - MD Anderson Cancer Center ( Site 0100)
  - Houston, Texas, United States, 77090
    - Millennium Research & Clinical Development ( Site 0143)
- Washington
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership ( Site 0106)
  - Spokane, Washington, United States, 99208
    - Medical Oncology Associates, PS ( Site 0142)
  - Tacoma, Washington, United States, 98405
    - Multicare Institute For Research And Innovation ( Site 0108)
  - Yakima, Washington, United States, 98902
    - Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).
Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.
Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
Is not expected to require tumor resection during the course of the study.
Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
Has a life expectancy of at least 6 months.
Has adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
Male and female participants who are at least 18 years of age at the time of signing the information consent.
Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:
- Pembrolizumab: 120 days
- Olaparib: 30 days

Exclusion Criteria:

Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access).
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - Pembrolizumab 200 mg Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.	Biological: Pembrolizumab 200 mg Pembrolizumab 200 mg Q3W Other Names: MK-3475 KEYTRUDA® Biological: Pembrolizumab 400 mg Pembrolizumab 400 mg Q6W Other Names: MK-3475 KEYTRUDA® 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.
Experimental: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.	Biological: Pembrolizumab 200 mg Pembrolizumab 200 mg Q3W Other Names: MK-3475 KEYTRUDA® Biological: Pembrolizumab 400 mg Pembrolizumab 400 mg Q6W Other Names: MK-3475 KEYTRUDA® 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. Drug: Olaparib 300 mg BID Olaparib 300 mg twice daily (BID) Other Names: MK-7339 LYNPARZA®
Placebo Comparator: Group C (Pembrolizumab and Olaparib Matching Placebos) Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.	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. Drug: Pembrolizumab placebo (saline) Pembrolizumab placebo (saline) Q3W Drug: Pembrolizumab placebo (saline) Pembrolizumab placebo (saline) Q6W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival: the time from randomization to death due to any cause Time Frame: Up to approximately 82 months	Overall Survival (OS) is the time from randomization to death due to any cause.	Up to approximately 82 months

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

Study Director: Medical Director, MD, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Rimner A, Lai WV, Califano R, Jabbour SK, Rudin CM, Faivre-Finn C, Cho BC, Kato T, Yu J, Chafin W, Yu L, Zhao B, Byers L. Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):e325-e329. doi: 10.1016/j.cllc.2022.04.005. Epub 2022 Apr 29.

Helpful Links

Merck Clinical Trials Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2027

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

7339-013
2019 (U.S. NIH Grant/Contract: Chief Medical Office (CMO) Alberta Health Services)
2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
MK-7339-013 (Other Identifier: MSD Protocol Number)
jRCT2031200296 (Registry Identifier: jRCT)
2019-003616-31 (EudraCT Number)
2023-504959-27-00 (Registry Identifier: EU CT)
U1111-1290-4870 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Outcome Measure	Measure Description	Time Frame
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first Time Frame: Up to approximately 59 months	Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) is the time from randomization to progression or death due to any cause, whichever occurs first.	Up to approximately 59 months
Number of Participants Experiencing an Adverse Events (AEs) Time Frame: Up to approximately 82 months	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to approximately 82 months
Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs) Time Frame: Up to approximately 82 months	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to approximately 82 months
Objective Response (OR): Complete Response (CR) or Partial Response (PR) Time Frame: Up to approximately 82 months	Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1.	Up to approximately 82 months
Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first Time Frame: Up to approximately 82 months	DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first.	Up to approximately 82 months
Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score Time Frame: Baseline and 82 months post randomization	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.	Baseline and 82 months post randomization
Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score Time Frame: Baseline and 82 months post randomization	The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.	Baseline and 82 months post randomization
Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score Time Frame: Baseline and 82 months post randomization	The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4 point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.	Baseline and 82 months post randomization
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score Time Frame: Baseline and 82 months post randomization	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.	Baseline and 82 months post randomization
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score Time Frame: Baseline and 82 months post randomization	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.	Baseline and 82 months post randomization
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score Time Frame: Up to approximately 82 months post randomization	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.	Up to approximately 82 months post randomization
Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score Time Frame: Up to approximately 82 months post randomization	The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQLC13 cough (Item 1) scale score.	Up to approximately 82 months post randomization
Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score Time Frame: Up to approximately 82 months post randomization	The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.	Up to approximately 82 months post randomization
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score Time Frame: Up to approximately 82 months post randomization	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.	Up to approximately 82 months post randomization
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score Time Frame: Up to approximately 82 months post randomization	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.	Up to approximately 82 months post randomization
Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels Time Frame: Up to approximately 82 months	Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.	Up to approximately 82 months
Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels Time Frame: Up to approximately 82 months	DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.	Up to approximately 82 months
Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels Time Frame: Up to approximately 59 months	Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.	Up to approximately 59 months
Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels Time Frame: Up to approximately 82 months	Overall Survival: the time from randomization to death due to any cause, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.	Up to approximately 82 months

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)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product