AzTrials
AzTrials

Small Cell Lung CancerPhase 3NCT04624204

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)

A Phase 3 study testing Pembrolizumab 200 mg, Pembrolizumab 400 mg and Olaparib 300 mg BID in people with Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 187 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Pembrolizumab 200 mg, Pembrolizumab 400 mg and Olaparib 300 mg BID
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
672 participants
Where
187 sitesin 25 countries
Study dates
8 Dec 2020to 15 Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

187 sites in 25 countries.

187 sites in 25 countries

United States35 sites

  • VA Ann Arbor Healthcare System ( Site 0050)

    Ann Arbor, Michigan, 48105

  • Harry & Jeanette Weinberg Cancer Institute ( Site 0045)

    Baltimore, Maryland, 21237

  • Memorial Sloan Kettering - Basking Ridge ( Site 0133)

    Basking Ridge, New Jersey, 07920

  • St. Vincent Healthcare Frontier Cancer Center ( Site 0056)

    Billings, Montana, 59102

  • Ironwood Cancer & Research Centers ( Site 0007)

    Chandler, Arizona, 85224

  • University of Chicago Medical Center ( Site 0136)

    Chicago, Illinois, 60637

  • Fairview Hospital-Moll Cancer Center ( Site 0141)

    Cleveland, Ohio, 44111

  • Cleveland Clinic Main ( Site 0139)

    Cleveland, Ohio, 44195

  • Memorial Sloan Kettering- Commack ( Site 0132)

    Commack, New York, 11725

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

    Dallas, Texas, 75231

  • Texas Oncology - Dallas (Sammons) ( Site 0093)

    Dallas, Texas, 75246

  • Providence Regional Cancer Partnership ( Site 0106)

    Everett, Washington, 98201

  • Fort Wayne Medical Oncology and Hematology ( Site 0034)

    Fort Wayne, Indiana, 46804

  • Saint Francis Cancer Center ( Site 0087)

    Greenville, South Carolina, 29607

  • John Theurer Cancer Center ( Site 0064)

    Hackensack, New Jersey, 07601

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

    Harrison, New York, 10604

  • Penn State Hershey Cancer Institute ( Site 0081)

    Hershey, Pennsylvania, 17033

  • MD Anderson Cancer Center ( Site 0100)

    Houston, Texas, 77030

  • Millennium Research & Clinical Development ( Site 0143)

    Houston, Texas, 77090

  • The University of Tennessee Medical Center ( Site 0116)

    Knoxville, Tennessee, 37920

  • University of Kentucky Chandler Medical Center ( Site 0138)

    Lexington, Kentucky, 40536

  • Loma Linda University Cancer Center ( Site 0011)

    Loma Linda, California, 92350

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

    Mayfield Heights, Ohio, 44124

  • Memorial Sloan Kettering - Monmouth ( Site 0135)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering - Bergen ( Site 0130)

    Montvale, New Jersey, 07645

  • Rutgers Cancer Institute of New Jersey ( Site 0123)

    New Brunswick, New Jersey, 08901

  • Memorial Sloan Kettering Cancer Center ( Site 0069)

    New York, New York, 10021

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

    Omaha, Nebraska, 68130

  • Overton Brooks VAMC ( Site 0041)

    Shreveport, Louisiana, 71101

  • Medical Oncology Associates, PS ( Site 0142)

    Spokane, Washington, 99208

  • Multicare Institute For Research And Innovation ( Site 0108)

    Tacoma, Washington, 98405

  • Moffitt Cancer Center ( Site 0137)

    Tampa, Florida, 33612

  • Memorial Sloan Kettering - Nassau ( Site 0131)

    Uniondale, New York, 11553

  • Georgetown University ( Site 0017)

    Washington D.C., District of Columbia, 20007

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

    Yakima, Washington, 98902

Other trials in United States

China28 sites

  • Peking Union Medical College Hospital ( Site 3102)

    Beijing, Beijing Municipality, 100006

  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)

    Beijing, Beijing Municipality, 100142

  • Beijing Cancer Hospital ( Site 3127)

    Beijing, Beijing Municipality, 130021

  • The First Hospital of Jilin University ( Site 3132)

    Changchun, Jilin, 130021

  • Xiangya Hospital of Central South University ( Site 3137)

    Changsha, Hunan, 410008

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

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital ( Site 3133)

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University ( Site 3114)

    Chengdu, Sichuan, 510115

  • Chongqing Cancer Hospital ( Site 3135)

    Chongqing, Chongqing Municipality, 400030

  • Daping Hospital,Third Military Medical University ( Site 3136)

    Chongqing, Chongqing Municipality, 400042

  • Fujian Provincial Cancer Hospital ( Site 3126)

    Fuzhou, Fujian, 350014

  • Hangzhou Cancer Hospital ( Site 3129)

    Hanghzou, Zhejiang, 310002

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

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital ( Site 3108)

    Hangzhou, Zhejiang, 310022

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

    Jinan, Shandong, 250117

  • The Second Affiliated Hospital of Nanchang University ( Site 3106)

    Nanchang, Jiangxi, 330006

  • Jiangsu Cancer Hospital ( Site 3139)

    Nanjing, Jiangsu, 210000

  • Shanghai Chest Hospital ( Site 3107)

    Shanghai, Shanghai Municipality, 200030

  • Shanghai Pulmonary Hospital ( Site 3101)

    Shanghai, Shanghai Municipality, 200443

  • Peking University Shenzhen Hospital ( Site 3118)

    Shenzhen, Guangdong, 518036

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

    Shenzhen, Guangdong, 518116

  • Tianjin Medical University Cancer Institute & Hospital ( Site 3103)

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430030

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

    Wuhan, Hubei, 430048

  • Hubei Cancer Hospital ( Site 3120)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen University ( Site 3121)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital ( Site 3105)

    Zhengzhou, Henan, 450008

Other trials in China

Japan16 sites

  • National Hospital Organization Kyushu Cancer Center ( Site 4000)

    Fukuoka, 811-1395

  • Kansai Medical University Hospital ( Site 4009)

    Hirakata, Osaka, 573-1191

  • Kobe Minimally Invasive Cancer Center ( Site 4003)

    Kobe, Hyōgo, 650-0046

  • Aichi Cancer Center ( Site 4010)

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center ( Site 4014)

    Nakatogari, Shizuoka, 411-8777

  • Niigata Cancer Center Hospital ( Site 4004)

    Niigata, 951-8566

  • Okayama University Hospital ( Site 4012)

    Okayama, 700-8558

  • Osaka International Cancer Institute ( Site 4005)

    Osaka, 541-8567

  • Takarazuka City Hospital ( Site 4013)

    Takarazuka, Hyōgo, 665-0827

  • Osaka Medical and Pharmaceutical University Hospital ( Site 4007)

    Takatsuki, Osaka, 569-8686

  • National Cancer Center Hospital ( Site 4015)

    Tokyo, 104-0045

  • Juntendo University Hospital ( Site 4008)

    Tokyo, 113-0033

  • Tokyo Metropolitan Komagome Hospital ( Site 4011)

    Tokyo, 113-8677

  • Cancer Institute Hospital of JFCR ( Site 4006)

    Tokyo, 135-8550

  • Showa Medical University Hospital ( Site 4002)

    Tokyo, 142-8666

  • Kanagawa Cancer Center ( Site 4001)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

France9 sites

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

    Angers, Maine-et-Loire, 49000

  • Hopital Avicenne ( Site 1106)

    Bobigny, Seine-Saint-Denis, 93000

  • CHU de Bordeaux Hop St ANDRE ( Site 1115)

    Bordeaux, Aquitaine, 33075

  • CHU Grenoble -Hop Michallon ( Site 1102)

    Grenoble, Isere, 38043

  • Clinique Clairval ( Site 1108)

    Marseille, Bouches-du-Rhone, 13009

  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)

    Paris, Île-de-France Region, 75014

  • Institut De Cancerologie De L Ouest ( Site 1110)

    Saint-Herblain, Loire-Atlantique, 44805

  • C.H. de Saint Quentin ( Site 1111)

    Saint-Quentin, Aisne, 02321

  • H.I.A. Sainte-Anne ( Site 1101)

    Toulon, Var, 83800

Other trials in France

Italy9 sites

  • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)

    Brescia, 25123

  • Azienda Ospedaliero Universitaria Careggi ( Site 1509)

    Florence, Firenze, 50134

  • IRCCS Ospedale San Raffaele ( Site 1500)

    Milan, 20132

  • Istituto Nazionale dei Tumori ( Site 1504)

    Milan, 20133

  • Istituto Europeo di Oncologia ( Site 1501)

    Milan, 20141

  • A O U Policlinico di Modena ( Site 1503)

    Modena, Emilia-Romagna, 41125

  • IRCCS Istituto Oncologico Veneto ( Site 1506)

    Padova, 35128

  • Policlinico Universitario Agostino Gemelli ( Site 1505)

    Roma, 00168

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

    Verona, Veneto, 37126

Other trials in Italy

South Korea8 sites

  • Inje University Haeundae Paik Hospital ( Site 3307)

    Busan, Pusan-Kwangyokshi, 48108

  • Keimyung University Dongsan Hospital CRC room 1 ( Site 3302)

    Daegu, Taegu-Kwangyokshi, 42601

  • National Cancer Center ( Site 3306)

    Goyang-si, Kyonggi-do, 10408

  • Seoul National University Bundang Hospital ( Site 3301)

    Seongnam-si, Kyonggi-do, 13620

  • Severance Hospital Yonsei University Health System ( Site 3304)

    Seoul, 03722

  • Samsung Medical Center ( Site 3300)

    Seoul, 06351

  • Asan Medical Center ( Site 3308)

    Songpagu, Seoul, 05505

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

    Suwon, Kyonggi-do, 16247

Other trials in South Korea

Ukraine8 sites

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

    Kapitanivka Village, Kyivska Oblast, 08111

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

    Kharkiv, Kharkiv Oblast, 61024

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

    Khmelnytskyi, Khmelnytskyi Oblast, 29009

  • Clinic of National Cancer Institute ( Site 2101)

    Kyiv, Kyivska Oblast, 03022

  • Medical Center Verum ( Site 2106)

    Kyiv, Kyivska Oblast, 03039

  • Kyiv City Clinical Oncology Center ( Site 2100)

    Kyiv, 03115

  • LISOD. Hospital ( Site 2111)

    Pliuty, Kyiv Oblast, 08720

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

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

Australia7 sites

  • Campbelltown Hospital ( Site 3002)

    Campbelltown, New South Wales, 2560

  • Frankston Hospital-Oncology and Haematology ( Site 3007)

    Frankston, Victoria, 3199

  • Austin Health-Austin Hospital ( Site 3006)

    Heidelberg, Victoria, 3084

  • Nepean Hospital ( Site 3001)

    Kingswood, New South Wales, 2747

  • Gold Coast University Hospital ( Site 3003)

    Southport, Queensland, 4215

  • Western Health-Sunshine Hospital ( Site 3004)

    St Albans, Victoria, 3021

  • Calvary Mater Newcastle ( Site 3000)

    Waratah, New South Wales, 2298

Other trials in Australia

Russia7 sites

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

    Balashikha, Moscow Oblast, 143900

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

    Kazan', Tatarstan, Respublika, 420029

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

    Moscow, Moscow, 105094

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

    Moscow, Moscow, 125284

  • Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603081

  • Omsk Clinical Oncology Dispensary ( Site 1806)

    Omsk, Omsk Oblast, 644013

  • Sverdlovsk Regional Oncology Hospital ( Site 1807)

    Yekaterinburg, Sverdlovsk Oblast, 620036

Other trials in Russia

Belgium6 sites

  • Saint-Luc UCL ( Site 1005)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • Grand Hopital de Charleroi ( Site 1003)

    Gilly, Hainaut, 6060

  • UZ Leuven ( Site 1002)

    Leuven, Vlaams-Brabant, 3000

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

    Mons, Hainaut, 7000

  • AZ Delta ( Site 1000)

    Roeselare, West-Vlaanderen, 8800

  • CHU UCL Namur Site de Godinne ( Site 1004)

    Yvoir, Namur, 5530

Other trials in Belgium

Hungary6 sites

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)

    Budapest, 1121

  • Orszagos Onkologiai Intezet ( Site 1310)

    Budapest, 1122

  • Uzsoki Utcai Korhaz ( Site 1303)

    Budapest, 1145

  • Petz Aladar Megyei Oktato Korhaz ( Site 1312)

    Győr, Győr-Moson-Sopron, 9024

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

    Kecskemét, Bács-Kiskun county, 6000

  • Reformatus Pulmonologiai Centrum ( Site 1304)

    Törökbálint, Pest County, 2045

Other trials in Hungary

Spain6 sites

  • Hospital Universitari Vall d Hebron ( Site 1904)

    Barcelona, 08035

  • Hospital Duran i Reynals ( Site 1903)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario 12 de Octubre ( Site 1902)

    Madrid, 28041

  • Hospital Regional Universitario de Malaga ( Site 1905)

    Málaga, 29010

  • Hospital Universitario Central de Asturias ( Site 1900)

    Oviedo, Principality of Asturias, 33011

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

    Seville, 41009

Other trials in Spain

United Kingdom6 sites

  • Royal Infirmary Aberdeen ( Site 2403)

    Aberdeen, Aberdeen City, AB25 2ZN

  • Ninewells Hospital and Medical School ( Site 2401)

    Dundee, Dundee City, DD1 9SY

  • Barts Health NHS Trust ( Site 2409)

    London, London, City of, EC1A 7BE

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

    London, London, City of, SE1 9RT

  • The Christie NHS Foundation Trust ( Site 2405)

    Manchester, M20 4GJ

  • Taunton and Somerset Hospital ( Site 2404)

    Taunton, England, TA1 5DA

Other trials in United Kingdom

Canada5 sites

  • Cross Cancer Institute ( Site 0206)

    Edmonton, Alberta, T6G 1Z2

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)

    Hamilton, Ontario, L8V 5C2

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

    Montreal, Quebec, H3T 1M5

  • McGill University Health Centre ( Site 0210)

    Montreal, Quebec, H4A 3J1

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

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Greece5 sites

  • Henry Dunant Hospital ( Site 1205)

    Athens, Attica, 115 26

  • Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)

    Athens, Attica, 115 27

  • University General Hospital of Herakleion ( Site 1202)

    Heraklion, Irakleio, 711 10

  • University General Hospital of Larisa ( Site 1201)

    Larissa, Thessaly, 411 10

  • Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)

    Thessaloniki, Central Macedonia, 54007

Other trials in Greece

Romania5 sites

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

    Bucharest, 022548

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

    Cluj-Napoca, Cluj, 400015

  • Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)

    Florești, Cluj, 407280

  • Spitalul Municipal Ploiesti ( Site 2801)

    Ploieşti, Prahova, 100337

  • Cabinet Medical Oncomed ( Site 2802)

    Timișoara, Timiș County, 300239

Other trials in Romania

Turkey (Türkiye)5 sites

  • Ankara Bilkent Sehir Hastanesi ( Site 2007)

    Ankara, 06800

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)

    Istanbul, 34098

  • Medipol Universite Hastanesi ( Site 2005)

    Istanbul, 34214

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

    Istanbul, 34722

  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

    Izmir, 35040

Other trials in Turkey (Türkiye)

Portugal3 sites

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

    Lisbon, Lisbon District, 1769-001

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

    Lisbon, 1099-023

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

    Porto, 4200-072

Other trials in Portugal

Estonia2 sites

  • SA Pohja-Eesti Regionaalhaigla ( Site 2201)

    Tallinn, Harju, 13419

  • SA Tartu Ulikooli Kliinikum ( Site 2200)

    Tartu, Tartu, 50406

Other trials in Estonia

Israel2 sites

  • Rambam Health Care Campus-Oncology Division ( Site 1401)

    Haifa, 3109601

  • Chaim Sheba Medical Center ( Site 1400)

    Ramat Gan, 5262000

Other trials in Israel

Lithuania2 sites

  • LSMUL Kauno Klinikos ( Site 2301)

    Kaunas, 50161

  • Nacionalinis Vezio Institutas ( Site 2300)

    Vilnius, Vilniaus Miestas, 08660

Other trials in Lithuania

Mexico2 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)

    Guadalajara, Jalisco, 44280

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

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Serbia2 sites

  • Institute for Oncology and Radiology of Serbia ( Site 2995)

    Belgrade, Beograd, 11000

  • Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)

    Kamenitz, Sremski Okrug, 21204

Other trials in Serbia

South Africa2 sites

  • Groote Schuur Hospital ( Site 5002)

    Cape Town, Western Cape, 7925

  • Steve Biko Academic Hospital ( Site 5000)

    Pretoria, Gauteng, 0002

Other trials in South Africa

Bulgaria1 site

  • MHAT "Uni Hospital" OOD ( Site 2507)

    Panagyurishte, Pazardzhik, 4500

Other trials in Bulgaria

About this study

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)

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.

Being tested
Pembrolizumab 200 mg, Pembrolizumab 400 mg, Pembrolizumab placebo (saline), Olaparib 300 mg BID, Olaparib matching placebo
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Pembrolizumab, Olaparib
Medical subject headings
Small Cell Lung Carcinoma, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab 200 mgBiological

    Also called MK-3475, KEYTRUDA®

    Pembrolizumab 200 mg Q3W

  • Pembrolizumab 400 mgBiological

    Also called MK-3475, KEYTRUDA®

    Pembrolizumab 400 mg Q6W

  • Pembrolizumab placebo (saline)Drug

    Pembrolizumab placebo (saline) Q3W

  • Pembrolizumab placebo (saline)Drug

    Pembrolizumab placebo (saline) Q6W

  • Olaparib 300 mg BIDDrug

    Also called MK-7339, LYNPARZA®

    Olaparib 300 mg twice daily (BID)

  • Olaparib matching placeboDrug

    Olaparib matching placebo BID

  • Etoposide 100 mg/m^2Drug

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

  • Platinum, investigator's choiceDrug

    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 RadiotherapyRadiation

    Standard Thoracic Radiotherapy

  • Prophylactic Cranial Irradiation (PCI)Radiation

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

Study groups in NCT04624204
Study groupRoleWhat they receive
Group A - Pembrolizumab 200 mgExperimentalParticipants 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.
Receives: Biological: Pembrolizumab 200 mg; Biological: Pembrolizumab 400 mg; Drug: Olaparib matching placebo; Drug: Etoposide 100 mg/m^2; Drug: Platinum, investigator's choice; Radiation: Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)
Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BIDExperimentalParticipants 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.
Receives: Biological: Pembrolizumab 200 mg; Biological: Pembrolizumab 400 mg; Drug: Olaparib 300 mg BID; Drug: Etoposide 100 mg/m^2; Drug: Platinum, investigator's choice; Radiation: Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)
Group C (Pembrolizumab and Olaparib Matching Placebos)Placebo comparatorParticipants 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.
Receives: Drug: Pembrolizumab placebo (saline); Drug: Olaparib matching placebo; Drug: Etoposide 100 mg/m^2; Drug: Platinum, investigator's choice; Radiation: Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival: the time from randomization to death due to any cause

    Overall Survival (OS) is the time from randomization to death due to any cause.

    Measured: Up to approximately 82 months

Secondary outcomes (19)

  1. 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

    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.

    Measured: Up to approximately 59 months

  2. Number of Participants Experiencing an Adverse Events (AEs)

    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.

    Measured: Up to approximately 82 months

  3. Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs)

    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.

    Measured: Up to approximately 82 months

  4. Objective Response (OR): Complete Response (CR) or Partial Response (PR)

    Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1.

    Measured: Up to approximately 82 months

  5. 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

    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.

    Measured: Up to approximately 82 months

  6. 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

    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.

    Measured: Baseline and 82 months post randomization

  7. Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score

    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.

    Measured: Baseline and 82 months post randomization

  8. Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score

    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.

    Measured: Baseline and 82 months post randomization

  9. Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

    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.

    Measured: Baseline and 82 months post randomization

  10. Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score

    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.

    Measured: Baseline and 82 months post randomization

  11. Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score

    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.

    Measured: Up to approximately 82 months post randomization

  12. Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score

    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.

    Measured: Up to approximately 82 months post randomization

  13. Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score

    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.

    Measured: Up to approximately 82 months post randomization

  14. Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

    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.

    Measured: Up to approximately 82 months post randomization

  15. Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score

    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.

    Measured: Up to approximately 82 months post randomization

  16. Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels

    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.

    Measured: Up to approximately 82 months

  17. Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels

    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.

    Measured: Up to approximately 82 months

  18. Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels

    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.

    Measured: Up to approximately 59 months

  19. Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels

    Overall Survival: the time from randomization to death due to any cause, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.

    Measured: Up to approximately 82 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2020
  2. Study start8 Dec 2020
  3. Primary completion28 Oct 2027 (estimated)
  4. Study completion15 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
672 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624204
Sponsor's protocol ID
7339-013
Other IDs
MK-7339-013, jRCT2031200296, 2023-504959-27-00, U1111-1290-4870, 2019-003616-31, 2019, 2023
Status last verified
Sep 2026
First submitted
5 Nov 2020
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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.

    PubMed 35613997

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab 200 mg, Pembrolizumab 400 mg and Olaparib 300 mg BID in people with Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 187 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States, China, Japan, France, Italy and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival: the time from randomization to death due to any cause (time frame: Up to approximately 82 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624204, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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