Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

870

Participants

Timeline

Start Date

July 6, 2020

Primary Completion Date

July 6, 2026

Study Completion Date

February 15, 2027

Conditions
Lung NeoplasmsCarcinoma, Non-Small-Cell Lung
Interventions
BIOLOGICAL

Pembrolizumab

intravenous (IV) infusion

DRUG

Olaparib

oral tablets

DRUG

Placebo for olaparib

oral tablets

DRUG

Etoposide

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Cisplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Pemetrexed

IV infusion

RADIATION

Thoracic Radiotherapy

external beam radiation

DRUG

Durvalumab

IV infusion

Trial Locations (205)

1002

Pauls Stradins Clinical University Hospital ( Site 1501), Riga

1079

Riga East Clinical University Hospital ( Site 1500), Riga

1121

Orszagos Koranyi Pulmonologiai Intezet ( Site 2305), Budapest

Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309), Budapest

1478

Akershus Universitetssykehus HF ( Site 1106), Lorenskog

1714

Sykehuset Oestfold ( Site 1107), Grålum

3004

Vestre Viken HF Drammen Sykehus ( Site 1101), Drammen

4011

Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103), Stavanger

5700

Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303), Gyula

6000

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302), Kecskemét

9024

Petz Aladar Megyei Oktato Korhaz ( Site 2306), Győr

10330

Chulalongkorn University ( Site 3003), Bangkok

10400

Ramathibodi Hospital. ( Site 3000), Bangkok

10408

National Cancer Center ( Site 2800), Goyang-si

10467

Montefiore Einstein Center ( Site 0083), The Bronx

13009

Clinique Clairval ( Site 0802), Marseille

13353

Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900), Berlin

13419

North Estonia Medical Centre Foundation ( Site 1601), Tallinn

13620

Seoul National University Bundang Hospital ( Site 2801), Seongnam-si

14080

Instituto Nacional de Cancerologia ( Site 0502), Tlalpan

15036

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606), Lima

Oncosalud ( Site 0605), Lima

15038

Detecta Clínica ( Site 0607), Surquillo

15088

Clinica San Gabriel ( Site 0601), Lima

15102

Hospital Nacional Cayetano Heredia ( Site 0602), Lima

16247

The Catholic University of Korea St. Vincent s Hospital ( Site 2805), Suwon

16499

Ajou University Hospital ( Site 2803), Suwon

19111

Fox Chase Cancer Center ( Site 0063), Philadelphia

20089

Istituto Clinico Humanitas Research Hospital ( Site 1000), Rozzano

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008), Milan

22087

Katholisches Marienkrankenhaus gGmbH ( Site 0902), Hamburg

22927

LungenClinic Grosshansdorf GmbH ( Site 0901), Großhansdorf

25011

LLC Ukrainian Center of Tomotherapy ( Site 2105), Kropyvnytskyi

27103

Piedmont Hematology-Oncology Associates ( Site 0080), Winston-Salem

27710

Duke University Medical Center ( Site 0050), Durham

28204

Novant Health Presbyterian ( Site 0081), Charlotte

28222

Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202), Majadahonda

28223

Hospital Universitario Quiron Madrid ( Site 1200), Pozuelo de Alarcón

28644

Chungbuk National University Hospital ( Site 2802), Cheongju-si

29011

H.R.U Malaga - Hospital General ( Site 1206), Málaga

29200

C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 0806), Brest

32429

Johannes Wesling Klinikum Minden ( Site 0908), Minden

32763

Mid Florida Hematology and Oncology Center ( Site 0022), Orange City

32806

Orlando Health, UF Health Cancer Center Inc ( Site 0092), Orlando

33021

Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095), Hollywood

33100

A.O.U. Santa Maria della Misericordia di Udine ( Site 1004), Udine

33125

Miami VA Healthcare System ( Site 0024), Miami

34098

Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000), Istanbul

34214

Medipol Universite Hastanesi ( Site 2003), Istanbul

34722

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001), Istanbul

35100

Ege University Medical Faculty ( Site 2005), Izmir

36604

University of South Alabama, Mitchell Cancer Institute ( Site 0003), Mobile

37075

Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917), Göttingen

40002

Srinagarind Hospital. Khon Kaen University ( Site 3002), Khon Kaen

40241

Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035), Louisville

40536

University of Kentucky ( Site 0096), Lexington

41009

Hospital Universitario Virgen Macarena ( Site 1205), Seville

41124

Policlinico di Modena ( Site 1007), Modena

41462

Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916), Neuss

41501

Pikeville Medical Center ( Site 0036), Pikeville

42601

Keimyung University Dongsan Hospital CRC room 1 ( Site 2807), Daegu

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500), Guadalajara

45219

The Lindner Center for Research and Education at The Christ Hospital ( Site 0060), Cincinnati

46026

Hospital Universitario La Fe ( Site 1203), Valencia

46804

Fort Wayne Medical Oncology and Hematology ( Site 0094), Fort Wayne

46845

Parkview Research Center ( Site 0032), Fort Wayne

47905

Franciscan Health Lafayette East ( Site 0031), Lafayette

48153

GEHO Muenster ( Site 0910), Münster

48202

Henry Ford Hospital ( Site 0045), Detroit

49055

Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107), Dnipro

50134

Azienda Ospedaliero Universitaria Careggi ( Site 1001), Florence

50161

Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201), Kaunas

50200

Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001), Chiang Mai

50406

Tartu University Hospital ( Site 1600), Tartu

52727

Gyeongsang National University Hospital ( Site 2804), Jinju

57104

Sanford Cancer Center Oncology Clinic ( Site 0066), Sioux Falls

59304

Clinique Teissier Groupe ( Site 0808), Valenciennes

60126

Azienda Ospedaliera Umberto I- Torrette ( Site 1009), Torrette

61024

SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology ( Site 2110), Kharkiv

63106

VA St. Louis Health Care System ( Site 0047), St Louis

63110

Washington University Siteman Cancer Center ( Site 0046), St Louis

64460

"Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0508)", Monterrey

68803

CHI Health St. Francis ( Site 0053), Grand Island

72401

St. Bernards Medical Center ( Site 0089), Jonesboro

73000

"Communal nonprofit enterprise Kherson Regional Oncology Dispensary of Kherson Regional Council ( Site 2109)", Antonivka Village

73100

Azienda Ospedaliera Vito Fazzi ( Site 1003), Lecce

74730

Centre Hospitalier Annecy Genevois ( Site 0811), Epagny Metz Tessy

80000

Clinique de l'Europe-Service de pneumologie ( Site 0816), Amiens

83800

H.I.A. Sainte-Anne ( Site 0815), Toulon

85925

CHD Vendee ( Site 0807), La Roche-sur-Yon

90404

UCLA Hematology/Oncology - Santa Monica ( Site 0013), Los Angeles

90505

Torrance Memorial Physician Network / Cancer Center ( Site 0093), Torrance

90806

Long Beach Memorial Medical Center ( Site 0006), Long Beach

92835

St Joseph Heritage Healthcare-Oncology ( Site 0088), Fullerton

93000

Hopital Avicenne ( Site 0803), Bobigny

94300

CLIMERS Clinical Medical Research ( Site 0506), Orizaba

95403

St. Joseph Heritage Healthcare Local Lab ( Site 0011), Santa Rosa

98108

Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075), Seattle

99216

Cancer Care Northwest ( Site 0074), Spokane Valley

99437

Zentralklinik Bad Berka GmbH ( Site 0905), Bad Berka

100006

Peking Union Medical College Hospital ( Site 3201), Beijing

100021

Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213), Beijing

100089

Beijing Cancer Hospital ( Site 3212), Beijing

125284

MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903), Moscow

130012

Jilin Cancer Hospital ( Site 3230), Changchun

130021

Beijing Cancer Hospital ( Site 3224), Beijing

150054

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910), Yaroslavl

197758

Medical institute named after Berezin Sergey ( Site 1906), Saint Petersburg

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905), Saint Petersburg

200030

Shanghai Chest Hospital ( Site 3207), Shanghai

200032

Zhongshan Hospital Fudan University ( Site 3220), Shanghai

200443

Shanghai Pulmonary Hospital ( Site 3203), Shanghai

200746

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2510), Craiova

210000

Jiangsu Cancer Hospital ( Site 3234), Nanjing

300060

Tianjin Medical University Cancer Institute & Hospital ( Site 3204), Tianjin

300166

S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509), Timișoara

300239

Policlinica Oncomed SRL ( Site 2504), Timișoara

310003

The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232), Hangzhou

330006

The Second Affiliated Hospital of Nanchang University ( Site 3206), Nanchang

350014

Fujian Provincial Cancer Hospital ( Site 3226), Fuzhou

361003

The First Affiliated Hospital of Xiamen University ( Site 3219), Xiamen

400015

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506), Cluj-Napoca

400042

Daping Hospital,Third Military Medical University ( Site 3235), Chongqing

407280

S.C. Radiotherapy Center Cluj S.R.L ( Site 2503), Comuna Floresti

410008

Xiangya Hospital of Central South University ( Site 3637), Changsha

410011

Second Xiangya Hospital of Central-South University ( Site 3227), Changsha

410013

Hunan Cancer Hospital ( Site 3225), Changsha

Hunan Cancer Hospital ( Site 3238), Changsha

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1911), Kazan'

430022

Wuhan Union Hospital Cancer Center ( Site 3222), Wuhan

430079

Hubei Cancer Hospital ( Site 3218), Wuhan

450008

Henan Cancer Hospital ( Site 3205), Zhengzhou

454087

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913), Chelyabinsk

510115

West China Hospital of Sichuan University ( Site 3202), Chengdu

518036

Peking University Shenzhen Hospital ( Site 3216), Shenzhen

518116

Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200), Shenzhen

603081

Nizhniy Novgorod Region Oncology Dispensary ( Site 1914), Nizhny Novgorod

620036

Sverdlovsk Regional Oncology Hospital ( Site 1909), Yekaterinburg

700483

Institutul Regional de Oncologie Iasi ( Site 2505), Iași

900591

Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501), Constanța

1240000

Bradford Hill Norte ( Site 0204), Antofagasta

2520598

Oncocentro ( Site 0203), Viña del Mar

4800827

Centro Investigación del Cáncer James Lind ( Site 0202), Temuco

7500713

OrlandiOncologia ( Site 0201), Providencia

8420383

Bradfordhill ( Site 0200), Santiago

02114

Massachusetts General Hospital ( Site 0038), Boston

08901

Rutgers Cancer Institute of New Jersey ( Site 0054), New Brunswick

07652

Valley Health Systems - Ridgewood Campus ( Site 0056), Paramus

C1430EGF

Clinica Adventista Belgrano-Oncology ( Site 4002), Caba.

X5800AEV

Instituto Médico Río Cuarto ( Site 4003), Río Cuarto

B3H 1V7

Queen Elizabeth II Health Sciences Centre ( Site 0100), Halifax

H2X 0A9

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102), Montreal

H3T 1M5

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108), Montreal

H4A 3J1

McGill University Health Center - Research Institute ( Site 0114), Montreal

G1J 1Z4

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0110), Québec

656 53

Masarykuv onkologicky ustav ( Site 2206), Brno

708 52

Fakultni nemocnice Ostrava ( Site 2201), Ostrava

100 34

Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200), Prague

150 006

Fakultni nemocnice v Motole ( Site 2210), Prague

262 04

Nemocnice Na Plesi s.r.o. ( Site 2202), Nová Ves pod Pleší

468 63

Krajska nemocnice Liberec, a.s. ( Site 2209), Liberec

128 08

Vseobecna fakultni nemocnice v Praze ( Site 2208), Prague

180 81

Nemocnice Na Bulovce ( Site 2205), Prague

07747

Universitaetsklinikum Jena ( Site 0911), Jena

00168

Policlinico Agostino Gemelli ( Site 1002), Rome

830-0011

Kurume University Hospital ( Site 3112), Kurume

650-0046

Kobe Minimally Invasive Cancer Center ( Site 3100), Kobe

241-8515

Kanagawa Cancer Center ( Site 3101), Yokohama

573-1191

Kansai Medical University Hospital ( Site 3103), Hirakata

569-8686

Osaka Medical and Pharmaceutical University Hospital ( Site 3110), Takatsuki

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 3104), Fukuoka

951-8566

Niigata Cancer Center Hospital ( Site 3109), Niigata

541-8567

Osaka International Cancer Institute ( Site 3106), Osaka

113-0033

Juntendo University Hospital ( Site 3111), Tokyo

113-8677

Tokyo Metropolitan Komagome Hospital ( Site 3108), Tokyo

135-8550

Cancer Institute Hospital of JFCR ( Site 3107), Tokyo

142-8666

Showa Medical University Hospital ( Site 3105), Tokyo

08660

National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200), Vilnius

0450

Oslo Universitetssykehus HF. Ulleval ( Site 1100), Oslo

04001

Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604), Arequipa

08-110

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404), Siedlce

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2402), Warsaw

81-519

Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400), Gdynia

10-228

SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401), Olsztyn

013823

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2500), Bucharest

031422

Gral Medical SRL-Medical Oncology ( Site 2511), Bucharest

050098

Spitalul Universitar de Urgenta Bucuresti ( Site 2508), Bucharest

075100

Radiology Therapeutic Center-Oncology ( Site 2502), Otopeni

03181

Kangbuk Samsung Hospital ( Site 2806), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 2808), Seoul

08035

H.U. Vall de Hebron ( Site 1201), Barcelona

08036

Hospital Clinic de Barcelona ( Site 1204), Barcelona

06800

Ankara Bilkent Sehir Hastanesi ( Site 2002), Ankara

06520

Memorial Ankara Hastanesi ( Site 2006), Ankara

08111

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

03022

SNPE National Cancer Institute ( Site 2101), Kyiv

03039

Medical Center Verum ( Site 2106), Kyiv

03115

Kyiv City Clinical Oncology Center ( Site 2100), Kyiv

S10 2SJ

Weston Park Hospital ( Site 1406), Sheffield

SE1 9RT

Guys and St Thomas NHS Foundation Trust ( Site 1410), London

NW1 2PG

University College Hospital NHS Foundation Trust ( Site 1403), London-Camden

SM3 5PT

Royal Marsden Hospital (Sutton) ( Site 1407), London

SO16 6YD

Southampton General Hospital ( Site 1400), Southampton

LS9 7TF

Leeds Teaching Hospitals NHS Trust ( Site 1401), Leeds

M20 4BX

Christie NHS Foundation Trust ( Site 1409), Manchester

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04380636 - Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) | Biotech Hunter | Biotech Hunter