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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

672

Participants

Timeline

Start Date

December 8, 2020

Primary Completion Date

October 28, 2027

Study Completion Date

October 28, 2027

Conditions
Small Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab 200 mg

Pembrolizumab 200 mg Q3W

BIOLOGICAL

Pembrolizumab 400 mg

Pembrolizumab 400 mg Q6W

DRUG

Pembrolizumab placebo (saline)

Pembrolizumab placebo (saline) Q3W

DRUG

Pembrolizumab placebo (saline)

Pembrolizumab placebo (saline) Q6W

DRUG

Olaparib 300 mg BID

Olaparib 300 mg twice daily (BID)

DRUG

Olaparib matching placebo

Olaparib matching placebo BID

DRUG

Etoposide 100 mg/m^2

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

DRUG

Platinum, investigator's choice

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

RADIATION

Standard Thoracic Radiotherapy

Standard Thoracic Radiotherapy

RADIATION

Prophylactic Cranial Irradiation (PCI)

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

Trial Locations (187)

1121

Orszagos Koranyi Pulmonologiai Intezet ( Site 1301), Budapest

1122

Orszagos Onkologiai Intezet ( Site 1310), Budapest

1145

Uzsoki Utcai Korhaz ( Site 1303), Budapest

1200

Saint-Luc UCL ( Site 1005), Brussels

2045

Reformatus Pulmonologiai Centrum ( Site 1304), Törökbálint

2298

Calvary Mater Newcastle ( Site 3000), Waratah

2560

Campbelltown Hospital ( Site 3002), Campbelltown

2747

Nepean Hospital ( Site 3001), Kingswood

3000

UZ Leuven ( Site 1002), Leuven

3021

Western Health-Sunshine Hospital ( Site 3004), St Albans

3084

Austin Health-Austin Hospital ( Site 3006), Heidelberg

3199

Frankston Hospital-Oncology and Haematology ( Site 3007), Frankston

4215

Gold Coast University Hospital ( Site 3003), Southport

4500

"MHAT Uni Hospital OOD ( Site 2507)", Panagyurishte

5530

CHU UCL Namur Site de Godinne ( Site 1004), Yvoir

6000

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

6060

Grand Hopital de Charleroi ( Site 1003), Gilly

7000

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

7925

Groote Schuur Hospital ( Site 5002), Cape Town

8800

AZ Delta ( Site 1000), Roeselare

9024

Petz Aladar Megyei Oktato Korhaz ( Site 1312), Győr

10021

Memorial Sloan Kettering Cancer Center ( Site 0069), New York

10408

National Cancer Center ( Site 3306), Goyang-si

10604

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

11000

Institute for Oncology and Radiology of Serbia ( Site 2995), Belgrade

11553

Memorial Sloan Kettering - Nassau ( Site 0131), Uniondale

11725

Memorial Sloan Kettering- Commack ( Site 0132), Commack

13009

Clinique Clairval ( Site 1108), Marseille

13419

SA Pohja-Eesti Regionaalhaigla ( Site 2201), Tallinn

13620

Seoul National University Bundang Hospital ( Site 3301), Seongnam-si

16247

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

17033

Penn State Hershey Cancer Institute ( Site 0081), Hershey

20007

Georgetown University ( Site 0017), Washington D.C.

20132

IRCCS Ospedale San Raffaele ( Site 1500), Milan

20133

Istituto Nazionale dei Tumori ( Site 1504), Milan

20141

Istituto Europeo di Oncologia ( Site 1501), Milan

21029

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

21204

Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991), Kamenitz

21237

Harry & Jeanette Weinberg Cancer Institute ( Site 0045), Baltimore

25123

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512), Brescia

28041

Hospital Universitario 12 de Octubre ( Site 1902), Madrid

29009

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

29010

Hospital Regional Universitario de Malaga ( Site 1905), Málaga

29607

Saint Francis Cancer Center ( Site 0087), Greenville

33011

Hospital Universitario Central de Asturias ( Site 1900), Oviedo

33075

CHU de Bordeaux Hop St ANDRE ( Site 1115), Bordeaux

33612

Moffitt Cancer Center ( Site 0137), Tampa

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009), Istanbul

34214

Medipol Universite Hastanesi ( Site 2005), Istanbul

34722

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

35040

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001), Izmir

35128

IRCCS Istituto Oncologico Veneto ( Site 1506), Padua

37126

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

37920

The University of Tennessee Medical Center ( Site 0116), Knoxville

38043

CHU Grenoble -Hop Michallon ( Site 1102), Grenoble

40536

University of Kentucky Chandler Medical Center ( Site 0138), Lexington

41009

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

41125

A O U Policlinico di Modena ( Site 1503), Modena

42601

Keimyung University Dongsan Hospital CRC room 1 ( Site 3302), Daegu

44111

Fairview Hospital-Moll Cancer Center ( Site 0141), Cleveland

44124

Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140), Mayfield Heights

44195

Cleveland Clinic Main ( Site 0139), Cleveland

44280

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

44805

Institut De Cancerologie De L Ouest ( Site 1110), Saint-Herblain

46804

Fort Wayne Medical Oncology and Hematology ( Site 0034), Fort Wayne

48105

VA Ann Arbor Healthcare System ( Site 0050), Ann Arbor

48108

Inje University Haeundae Paik Hospital ( Site 3307), Busan

49000

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

50134

Azienda Ospedaliero Universitaria Careggi ( Site 1509), Florence

50161

LSMUL Kauno Klinikos ( Site 2301), Kaunas

50406

SA Tartu Ulikooli Kliinikum ( Site 2200), Tartu

54007

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

59102

St. Vincent Healthcare Frontier Cancer Center ( Site 0056), Billings

60637

University of Chicago Medical Center ( Site 0136), Chicago

61024

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

64460

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

68130

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

71101

Overton Brooks VAMC ( Site 0041), Shreveport

75014

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

75231

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

75246

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

77030

MD Anderson Cancer Center ( Site 0100), Houston

77090

Millennium Research & Clinical Development ( Site 0143), Houston

83800

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

85224

Ironwood Cancer & Research Centers ( Site 0007), Chandler

92350

Loma Linda University Cancer Center ( Site 0011), Loma Linda

93000

Hopital Avicenne ( Site 1106), Bobigny

98201

Providence Regional Cancer Partnership ( Site 0106), Everett

98405

Multicare Institute For Research And Innovation ( Site 0108), Tacoma

98902

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

99208

Medical Oncology Associates, PS ( Site 0142), Spokane

100006

Peking Union Medical College Hospital ( Site 3102), Beijing

100021

Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104), Beijing

100142

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

100337

Spitalul Municipal Ploiesti ( Site 2801), Ploieşti

105094

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

125284

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

130021

Beijing Cancer Hospital ( Site 3127), Beijing

The First Hospital of Jilin University ( Site 3132), Changchun

143900

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

200030

Shanghai Chest Hospital ( Site 3107), Shanghai

200443

Shanghai Pulmonary Hospital ( Site 3101), Shanghai

210000

Jiangsu Cancer Hospital ( Site 3139), Nanjing

250117

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

300060

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

300239

Cabinet Medical Oncomed ( Site 2802), Timișoara

310002

Hangzhou Cancer Hospital ( Site 3129), Hanghzou

310003

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

310022

Zhejiang Cancer Hospital ( Site 3108), Hangzhou

330006

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

350014

Fujian Provincial Cancer Hospital ( Site 3126), Fuzhou

361003

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

400015

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

400030

Chongqing Cancer Hospital ( Site 3135), Chongqing

400042

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

407280

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805), Florești

410008

Xiangya Hospital of Central South University ( Site 3137), Changsha

410011

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

410013

Hunan Cancer Hospital ( Site 3133), Changsha

420029

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

430030

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

430048

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

430079

Hubei Cancer Hospital ( Site 3120), Wuhan

450008

Henan Cancer Hospital ( Site 3105), Zhengzhou

510115

West China Hospital of Sichuan University ( Site 3114), Chengdu

518036

Peking University Shenzhen Hospital ( Site 3118), Shenzhen

518116

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

603081

Nizhniy Novgorod Region Oncology Dispensary ( Site 1811), Nizhny Novgorod

620036

Sverdlovsk Regional Oncology Hospital ( Site 1807), Yekaterinburg

644013

Omsk Clinical Oncology Dispensary ( Site 1806), Omsk

3109601

Rambam Health Care Campus-Oncology Division ( Site 1401), Haifa

5262000

Chaim Sheba Medical Center ( Site 1400), Ramat Gan

07920

Memorial Sloan Kettering - Basking Ridge ( Site 0133), Basking Ridge

07601

John Theurer Cancer Center ( Site 0064), Hackensack

07748

Memorial Sloan Kettering - Monmouth ( Site 0135), Middletown

07645

Memorial Sloan Kettering - Bergen ( Site 0130), Montvale

08901

Rutgers Cancer Institute of New Jersey ( Site 0123), New Brunswick

T6G 1Z2

Cross Cancer Institute ( Site 0206), Edmonton

L8V 5C2

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

H3T 1M5

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

H4A 3J1

McGill University Health Centre ( Site 0210), Montreal

G8Z 3R9

CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200), Trois-Rivières

02321

C.H. de Saint Quentin ( Site 1111), Saint-Quentin

115 26

Henry Dunant Hospital ( Site 1205), Athens

115 27

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

711 10

University General Hospital of Herakleion ( Site 1202), Heraklion

411 10

University General Hospital of Larisa ( Site 1201), Larissa

00168

Policlinico Universitario Agostino Gemelli ( Site 1505), Roma

464-8681

Aichi Cancer Center ( Site 4010), Nagoya

650-0046

Kobe Minimally Invasive Cancer Center ( Site 4003), Kobe

665-0827

Takarazuka City Hospital ( Site 4013), Takarazuka

241-8515

Kanagawa Cancer Center ( Site 4001), Yokohama

573-1191

Kansai Medical University Hospital ( Site 4009), Hirakata

569-8686

Osaka Medical and Pharmaceutical University Hospital ( Site 4007), Takatsuki

411-8777

Shizuoka Cancer Center ( Site 4014), Nakatogari

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 4000), Fukuoka

951-8566

Niigata Cancer Center Hospital ( Site 4004), Niigata

700-8558

Okayama University Hospital ( Site 4012), Okayama

541-8567

Osaka International Cancer Institute ( Site 4005), Osaka

104-0045

National Cancer Center Hospital ( Site 4015), Tokyo

113-0033

Juntendo University Hospital ( Site 4008), Tokyo

113-8677

Tokyo Metropolitan Komagome Hospital ( Site 4011), Tokyo

135-8550

Cancer Institute Hospital of JFCR ( Site 4006), Tokyo

142-8666

Showa Medical University Hospital ( Site 4002), Tokyo

08660

Nacionalinis Vezio Institutas ( Site 2300), Vilnius

1769-001

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

1099-023

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

4200-072

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

022548

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

0002

Steve Biko Academic Hospital ( Site 5000), Pretoria

05505

Asan Medical Center ( Site 3308), Songpagu

03722

Severance Hospital Yonsei University Health System ( Site 3304), Seoul

06351

Samsung Medical Center ( Site 3300), Seoul

08908

Hospital Duran i Reynals ( Site 1903), L'Hospitalet de Llobregat

08035

Hospital Universitari Vall d Hebron ( Site 1904), Barcelona

06800

Ankara Bilkent Sehir Hastanesi ( Site 2007), Ankara

08720

LISOD. Hospital ( Site 2111), Pliuty

08111

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

03022

Clinic of National Cancer Institute ( Site 2101), Kyiv

03039

Medical Center Verum ( Site 2106), Kyiv

03115

Kyiv City Clinical Oncology Center ( Site 2100), Kyiv

AB25 2ZN

Royal Infirmary Aberdeen ( Site 2403), Aberdeen

DD1 9SY

Ninewells Hospital and Medical School ( Site 2401), Dundee

TA1 5DA

Taunton and Somerset Hospital ( Site 2404), Taunton

EC1A 7BE

Barts Health NHS Trust ( Site 2409), London

SE1 9RT

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

M20 4GJ

The Christie NHS Foundation Trust ( Site 2405), Manchester

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04624204 - 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) | Biotech Hunter | Biotech Hunter