Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

483

Participants

Timeline

Start Date

June 1, 2017

Primary Completion Date

January 27, 2020

Study Completion Date

March 26, 2020

Conditions
Small Cell Lung Cancer
Interventions
BIOLOGICAL

Dinutuximab

Dinutuximab injection, for intravenous (IV) use

DRUG

Irinotecan

Irinotecan injection, IV infusion

DRUG

Topotecan

Topotecan for injection

Trial Locations (226)

402

Chung Shan Medical University Hospital, Taichung

736

Chi Mei Hospital, Liouying, Tainan City

1000

Manila Doctors Hospital, Manila

1102

St. Luke's Medical Center - Quezon City, Quezon City

St. Luke's Medical Centre, Quezon City

1121

Koranyi National Institute of Pulmonology - Horváth, Budapest

Koranyi National Institute of TBC and Pulmonology, Budapest

Korányi National Institute, Budapest

1125

Semmelweis Egyetem AOK Pulmonologiai Klinika, Budapest

1303

First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia, Sofia

1330

Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia, Sofia

1431

Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia, Sofia

1756

Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia, Sofia

1797

Clinic of Oncology, UMHAT SofiaMed, Sofia

2045

Tudogyogyintezet Torokbalint, Törökbálint

2700

Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad, Blagoevgrad

2800

Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza, Tatabánya

3233

Matrai Gyogyintezet, Mátraháza

3350

Ballarat Health Services, Ballarat

3529

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály, Miskolc

4001

Clinic of Oncology, UMHAT Pulmed, Plovdiv

4004

First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD, Plovdiv

4500

Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte, Panagyurishte

5000

Royal Adelaide Hospital, Adelaide

5004

Hetenyi Geza Hospital, Szolnok

5300

Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo, Gabrovo

5800

Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven, Pleven

6000

LTD High Technology Hospital Medcenter, Batumi

Cebu Doctors University Hospital, Cebu City

8000

Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas, Burgas

Davao Doctors Hospital, Davao City

8582

Veszprém Megyei Tüdőgyógyintézet, Farkasgyepű

8900

Zala Megyei Szent Rafael Korhaz, Zalaegerszeg

9010

Clinic of Oncology, MHAT Sveta Marina, Varna

9300

Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich, Dobrich

10330

King Chulalongkorn Memorial Hospital, Bangkok

10400

National Cancer Institute of Thailand, Bangkok

10700

Siriraj Hopsital, Bangkok

13009

Institut Paoli-Calmettes, Service Dòncologie Médicale, Marseille

13496

CHA Bundang Medical Center, Gyeonggi-do

13620

Seoul National University Bundang Hospital, Gyeonggi-do

13915

Hopital Nord, Marseille

14000

Centre François Baclesse, Caen

14004

Hospital Universitario Reina Sofia, Córdoba

15006

CHU A Coruña, A Coruña

17007

Instituto Catalán de Oncología (ICO) - Josep Trueta, Girona

19111

Fox Chase Cancer Center Office of Clinical Research, Philadelphia

19124

Cancer Treatment Centers of America at Eastern Regional Medical Center, Philadelphia

20123

Istituto Nazionale dei Tumori, Milan

21029

"Municipal Nonprofit Institution Podilsky Regional Oncology Center of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy", Vinnitsya

22332

Inha University Hospital, Incheon

26101

Camden Clark Medical Center / Regional Cancer Center, Parkersburg

26330

United Hospital Center, Bridgeport

26426

Wonju Severance Christian Hospital, Wonju-Si, Gangwon-do

27003

Hospital Universitario Lucus Augusti, Lugo

28007

Hospital General Universitário Gregorio Marañón, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Hospital Universitario Madrid Norte Sanchinarro, Madrid

28222

Hospital Universitario Puerta de Hierro, Majadahonda

28644

Chungbuk National University Hospital, Chungcheongbuk-do

28938

H. M. Puerta del Sur (H. Móstoles), Madrid

29006

Hospital Regional de Málaga (H. Carlos Haya), Málaga

29303

Spartanburg Medical Center/Gibbs Cancer Center and Research Institute, Spartanburg

29414

Charleston Oncology, Charleston

29609

CHU Brest, Brest

30060

Northwest Georgia Oncology Centers, P.C., Marietta

30322

Winship Cancer Institute, Emory University, Atlanta

31008

Complejo Hospitalario de Navarra, Pamplona

32005

Complexo Hospitalario Universitario de Ourense (CHUO), Ourense

32204

21st Century Oncology, Jacksonville

32713

Alpha Oncology Research LLC, DeBary

33305

Chang-Gung Memorial Hospital, Linkou, Taoyuan

33709

Comprehensive Hematology Oncology, St. Petersburg

34298

Institut Regional du Cancer de Montpellier, Montpellier

35015

Chungnam National University Hospital, Daejeon

36312

Hospital Álvaro Cunqueiro, Vigo

37909

Center for Biomedical Research, Knoxville

39008

Hospital Universitario Marqués de Valdecilla, Santander

40002

Srinagarind Hospital, Khon Kaen

40215

21st Century Oncology, Louisville

40506

University of Kentucky, Lexington

41014

Hospital Universitario Virgen de Valme, Seville

41404

Kyungpook National University Medical Center, Daegu

Kyungpook University Chilgok Hospital, Daegu

41701

Kentucky Cancer Clinic, Hazard

42445

E-Da Hospital, Kaohsiung City

42601

Keimyung University Dongsan Medical Centre, Daegu

44033

Ulsan University Hospital, Ulsan

44106

UH Cleveland Medical Center, Cleveland

44805

Institut de Cancérologie de l'Ouest - Centre René Gauducheau, Saint-Herblain

46026

Hospital Universitario y Politécnico de La Fe, Valencia

47150

Baptist Health Floyd Cancer Center, New Albany

49055

Institut de Cancérologie de l'Ouest - Centre Paul Papin, Angers

49102

"Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council, Municipal Institution Multifield Dnipropetrovsk City Hospital #4 of Dnipropetrovsk Regional Council, Department of Chemotherapy", Dnipro

49267

Kosin University Gospel Hospital, Busan

50009

Hospital Lozano Blesa, Zaragoza

50161

Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos, Kaunas

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

50586

Hospital Kuala Lumpur, Kuala Lumpur

50612

Pusan National University Yangsan Hospital, Gyeongsangnam-do

52403

Physicians' Clinic of Iowa Hematology and Oncology, Cedar Rapids

53792

University of Wisoncsin - Carbone Cancer Ctr, Madison

57201

Prairie Lakes Health Care, Watertown

58013

Regional Communal Nonprofit Enterprise, Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary, Surgery Department, State Higher Educational Establishment of Ukraine, Bukovinian State Medical University, Department of Onc and Radiology, Chernivtsi

58128

Chonnam National University Hwasun Hospital, Jeonnam

59101

Billings Clinic Cancer Center, Billings

59102

St. Vincent Frontier Cancer Center, Billings

62250

National Cancer Institute, Putrajaya

65000

Naresuan University Hospital, Phitsanulok

65055

"Municipal Nonprofit Institution Odessa Regional Oncology Dispensary of Odessa Regional Council, Municipal Institution Odesa Regional Oncology Dispensary, Hospital of Day Stay (Unit of Dispensary-Polyclinic Department)", Odesa

65807

Cox Health Medical, Springfield

67065

Centre Paul Strauss, Strasbourg

67091

Nouvel Hôpital Civil de Strasbourg, Strasbourg

69004

URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse, Lyon

69677

URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse, Bron

69945

Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud, Pierre-Bénite

71913

Genesis Cancer Center, Hot Springs

72000

Clinique Victor Hugo, Le Mans

74133

Cancer Treatment Centers of America at Southwestern RMC, Tulsa

75093

Plano Cancer Institute, Plano

75701

The University of Texas Health Science Center at Tyler, Office of Clinical Studies, Tyler

76012

Texas Health Physicians Group, Arlington

82445

E-Da Hospital, Kaohsiung City

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

85338

Cancer Treatment Centers of America - Western Regional Medical Center, Goodyear

85745

Innovative Clinical Research Institute, Tucson

87131

The University of New Mexico Comprehensive Cancer Center, Albuquerque

88000

"Municipal Nonprofit Institution Cental Municipal Clinical Hospital of Uzhgorod City Council, Municipal Oncology Centre", Uzhhorod

90033

USC Norris Comprehensive Cancer Center, Los Angeles

90110

Songklanagarind Hospital, Songkhla

90603

Innovative Clinical Research Institute, Whittier

91342

Olive View - UCLA, Sylmar

93586

Hospital Umum Sarawak, Kuching

94010

CHI Créteil, Créteil

94304

VA Palo Alto Health Care System, Palo Alto

95122

Dipartimento di Oncologia, ARNAS Garibaldi, Catania

97227

Kaiser Permanente Northwest Center for Health Research CRSS, Portland

98584

Vista Oncology (Shelton office), Shelton

99503

Alaska Clinical Research Center, Anchorage

115478

Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation, Moscow

143423

State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department, Moscow

150054

State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital, Yaroslavl

163045

State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary, Arkhangelsk

194291

State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital, Saint Petersburg

197183

Center of Palliative Care-Devita LLC, Saint Petersburg

197342

BioEq, LLC, Saint Petersburg

197758

Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov, Saint Petersburg

State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological), Saint Petersburg

198255

Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary, Saint Petersburg

200385

SC Oncolab LTD, Craiova

300166

Oncocenter Oncology Clinic LTD, Timișoara

302004

Birla Cancer Centre, SMS Hospital, Jaipur

302017

Bhagawan Mahaveer Cancer Hospital, Jaipur

305524

Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region, Kursk

400015

Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca, Cluj-Napoca

400026

Jaslok Hospital & Research Center, Mumbai

400058

Medisprof LTD, Cluj-Napoca

411001

Deenanath Mangeshkar Hospital, Pune

Grant Medical Foundation Ruby Hall Clinic, Pune

430291

Oncopremium Team LTD, Baia Mare

440055

Emergency County Hospital Satu-Mare, Medical Oncology Clinic, Satu Mare

443031

State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary, Samara

460021

State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary, Orenburg

560020

Healthcare Global (HCG) Towers, Bangalore

560076

Sri Venkateshwara Hospitals, Bangalore

590010

KLES Dr Prabhakar Kore Hospital & MRC, Nehru Nagar

620036

State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary, Yekaterinburg

630047

State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1, Novosibirsk

630108

State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary, Novosibirsk

644013

Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary, Omsk

720224

Emergency Hospital ,Sf. Ioan cel Nou', Suceava

06062

Hartford Hospital, Hartford

06360

Eastern Connecticut Hematology and Oncology Assoc, Norwich

NSW 2450

Mid North Coast Cancer Institute Coff Habour Health Campus, Coffs Harbour

QLD 4101

Mater Misericordiae Limited and Mater Medical Research Institute Limited, South Brisbane

T6G 1Z2

Cross Cancer Institute - Clinical Trials Unit, Edmonton

E1C 6Z8

Horizon Health Network - The Moncton Hosoital, Moncton

M5G 2M9

Princess Margaret Cancer Centre, Toronto

N8W 2X3

Windsor Regional Hospital Cancer Program, Windsor

H4A 3J1

McGill University Health Center, Montreal

G1V 4G5

L'Institut Universitaire de Cardiologie et de pneumologie de Quebec, Québec

0112

LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine'', Tbilisi

0144

High Technology Medical Center, University Clinic, Tbilisi

0159

Institute of Clinical Oncology, Tbilisi

0186

Multiprofile Clinic Consillium Medulla, Tbilisi

Unknown

Princess Margaret Hospital, Kowloon

Queen Elizabeth Hospital, Kowloon

Queen Mary Hospital, Pokfulam

Istituto Europeo di Oncologia (IEO), Milano, Milan

Ospedale Santa Maria della Misericordia, Perugia, Perugia

A.O.U. San Luigi Gonzaga, Orbassano (Torino), Torino

Department of Medicine, Faculty of Medicine, Kuala Lumpur

SC Oncology Center Sf. Nectarie LTD, Craiova

"State Budgetary Healthcare Institution of Arkhangelsk region Arkhangelsk Clinical Oncology Dispensary", Moscow

Gachon Universtiy Gil Medical Center, Namdong

I-00128

Radiation Oncology, Campus Bio-Medico University, Rome

I-53100

Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Siena

08660

National Cancer Institute, Vilnius

08661

Vilnius University Hospital Santaros Klinikos, Vilnius

82-550

Szpital Specjalistyczny w Prabutach Sp. z o.o, Prabuty

10-357

Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie, Olsztyn

05-320

Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina, Mrozy

05-400

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock

44-145

Szpital Chorób Płuc im Św. Józefa w Pilchowicach, Pilchowice

60-569

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów, Poznan

02-781

Centrum Onkologii-Instytut im. Sklodowskiej-Curie, Warsaw

04-141

Wojskowy Instytut Medyczny, Warsaw

90-242

Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna, Lodz

08501

St. Jacob´s Hospital Bardejov - Department of Clinical Oncology, Bardejov

012 07

Faculty Hospital Zilina, Žilina

02841

Korea University Anam Hospital, Seoul

07061

Seoul National University Boramae Medical Center, Seoul

03203

Hospital General Universitario de Elche, Elche

03010

Hospital General de Alicante, Alicante

08028

Hospital Quirón Dexeus, Barcelona

08035

Hospital Universitari Vall d´Hebron, Barcelona

03804

Hospital Virgen de los Lirios Alcoy, Planta

08208

Corporació Sanitària Parc Taulí, Sabadell

03115

"Communal Non-profit Enterprise Kyiv City Clinical Oncology Center of Executive body of Kyiv City Council, Kyiv City Clinical Oncology Center by Main Department of Health Protection Kyiv, Hospital of Day Stay for Oncology Patients", Kiev

CM20 1QX

Princess Alexandra Hospital, Harlow

SW3 6JJ

Royal Marsden Hospital, Chelsea

LS9 7TF

St James' Institute of Oncology, Leeds

EC1A 7BE

St Bartholomew's Hospital, London

NW3 2QG

Royal Free Hospital, London

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust, London

SM2 5PT

Royal Marsden Hospital, Sutton

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY

NCT03098030 - Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter