Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

613

Participants

Timeline

Start Date

August 30, 2016

Primary Completion Date

February 24, 2020

Study Completion Date

February 24, 2020

Conditions
Small-cell Lung Cancer
Interventions
DRUG

Lurbinectedin (PM01183)

DRUG

Doxorubicin (DOX)

DRUG

Cyclophosphamide (CTX)

DRUG

Vincristine (VCR)

DRUG

Topotecan

Trial Locations (160)

1090

Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie, Vienna

1121

Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia, Budapest

Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia, Budapest

1330

"Multiprofile Hospital for Active Treatment of Women Health - Nadezhda, Sofia; Clinic of Medical Oncology", Sofia

1431

"University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski, Sofia", Sofia

1784

Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology, Sofia

2800

Szent Borbála Kórház, Pulmonológiai osztály, Tatabánya

3233

Mátrai Gyógyintézet, Bronchológia, Mátraháza

3529

Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály, Miskolc

4000

CHR de la citadelle, Liège

CHU de Liege - Sart Tilman, Liège

4040

Clinique André Renard, Herstal

4500

Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte, Panagyurishte

5020

Universitätsklinik für Innere Medizin III der PMU, Salzburg

7000

CHU Ambroise Paré, Mons

8000

Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály, Székesfehérvár

8582

Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály, Farkasgyepű

8800

AZ Delta Campus Wilgenstraat, Roeselare

8900

Zala Megyei Kórház, Pulmonologia, Zalaegerszeg

9000

AZ Maria Middelares, Ghent

9700

Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály, Szombathely

10967

Vivantes Klinikum am Urban, Hämatologie und Onkologie, Berlin

11527

"General Hospital of Chest Diseases of Athens Sotiria", Athens

13125

Evangelische Lungenklinik Berlin, Berlin

13915

Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques, Marseille

14004

Hospital Universitario Reina Sofia, Córdoba

14076

Centre François Baclesse, Caen

14564

"General Oncology Hospital of Kifissia Agioi Anargiroi, 2nd Internal Medicine-Oncology Clinic", Athens

19013

Associates in Hematology and Oncology, P.C., Upland

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21401

Anne Arundel Medical Center Oncology and Hematology, Annapolis

23100

ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio, Sondrio

26789

Onkologische Schwerpunktpraxis Leer-Emden, Leer

28033

MD Anderson Cancer Center Madrid, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Universitario Clínico San Carlos, Madrid

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28100

AOU Maggiore della Carità - SC Oncologia, Novara

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

28374

FirstHealth Outpatient Cancer Center, Pinehurst

29010

Hospital Regional Universitario de Malaga, Málaga

32429

Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin, Minden

33076

Institut Bergonié, Bordeaux

33081

Centro di Riferimento Oncologico di Aviano, Aviano

33308

Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale

33486

Boca Raton Regional Hospital Lynn Cancer Institute, Boca Raton

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

35033

CHU de Rennes Hôpital Pontchaillou, Rennes

35128

Istituto Oncologico Veneto, Padua

35243

Alabama Oncology, Birmingham

40202

Norton Cancer Institute, Louisville

40353

Montgomery Cancer Center, Mount Sterling

41013

Complejo hospitalario regional virgen rocío, Seville

42123

lRCCS-Arcispedale Santa Maria Nuova, Reggio Emilia

42283

Medizinische Klinik I, Wuppertal

44718

Gabrail Cancer Center Research, Canton

46014

Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitario La Fe de Valencia, Valencia

48073

QUEST Research Institute, Royal Oak

50009

Hospital Universitario Miguel Servet, Zaragoza

53226

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee

56073

Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz, Koblenz

57010

"General Hospital of Thessaloniki G. Papanikolaou, Pulmonary Clinic, Aristotle University of Thessaloniki", Thessaloniki

58675

Lungenklinik Hemer, Hemer

60435

Joliet Oncology-Hematology Associates, Ltd., Joliet

60487

Healthcare Research Network III, LLC, Tinley Park

61801

Carle Cancer Center, Urbana

68167

Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim, Mannheim

69126

Thoraxklinik Heidelberg GmbH, Heidelberg

69310

Centre Hospitalier Lyon Sud - Service de Pneumologie, Lyon

70006

East Jefferson Hematology-Oncology Metairie Physicians Services, Inc, Metairie

70839

Center for Pneumology and Thoracic Surgery, Gerlingen

71110

"University General Hospital of Heraklion - General Hospital Venizeleio", Heraklion

74146

Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa

74245

Klinik Löwenstein gGmbH, Med. Klinik II Onkologie, Löwenstein

75701

Tyler Hematology-Oncology PA, Tyler

76104

The Center for Cancer and Blood Disorders, Fort Worth

76137

VIDIA Christliche Kliniken Karlsruhe, Karlsruhe

79106

Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation, Freiburg im Breisgau

80336

University of Munich LMU, Dpt. of Medicine V, München

81737

Städtisches Krankenhaus München Neuperlach, München

81925

Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie, München

82131

Asklepios-Fachkliniken München Gauting, Gauting

85028

IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico), Rionero in Vulture

85224

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers, Chandler

89081

Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie, Ulm

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90419

Klinikum Nürnberg Nord - Pneumologische Onkologie, Nuremberg

90603

Innovative Clinical Research Institute (ICRI), Whittier

92354

Loma Linda University Medica! Center, Loma Linda

92835

St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare, Fullerton

94010

Centre Hospitalier Intercommunal de Créteil, Créteil

95123

"Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Presidio G. Rodolico", Catania

98405

MultiCare Institute for Research & Innovation, Tacoma

99208

Medical Oncology Associates PS (dba Summit Cancer Centers), Spokane

99437

Central Clinic of Bad Berka, Bad Berka

200347

SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala, Craiova

200385

SC Oncolab SRL, Craiova

400015

"Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca, Departament Oncologie Medicala", Cluj-Napoca

"Institutul Oncologic Prof. Dr. lon Chiricuta Cluj-Napoca, Dcpartamentul Oncologie Medicala", Cluj-Napoca

"Institutul Oncologic Prof. Dr. lon Chiricuta Cluj-Napoca, Sectia Oncologic Medicala", Cluj-Napoca

430031

"Spitalul Judetean de Urgenta Dr. Constantin Opris, Sectia Oncologie Medicala", Baia Mare

900591

"Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei", Constanța

02114

Massachusetts General Hospital, Boston

03756

Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital, Lebanon

07932

Summit Medical Group, P.A., Florham Park

C1426ANZ

Instituto Médico Especializado Alexander Fleming, C.a.b.a.

T4000GTB

Centro para la Atención Integral del Paciente Oncológico (CAIPO), San Miguel de Tucumán

X5000HLX

Instituto Oncológico de Córdoba (IONC), Córdoba

F5300COE

CORI - Centro Oncológico Riojano Integral, La Rioja

S3000FFU

ISIS Centro Especializado de Luce S.A., Santa Fe

40170-110

Nucleo de Oncologia da Bahia, Salvador

80530-010

lOP- Instituto de oncologia do paraná, Curitiba

20231-092

Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer, Rio de Janeiro

22793-080

Instituto COl de Pesquisa, Educação e Gestão, Rio de Janeiro

98700-000

Associação Hospital de Caridade de Ijuí, Ijuí

90020-090

lrmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

90610-000

Hospital São Lucas da PUCRS, Porto Alegre

90.035-903

Hospital de clínicas de Porto alegre, Pôrto Alegre

14784-400

Fundação PlO XII - Hospital de Câncer de Barretos, Barretos

01236-030

lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas, São Paulo

L3Y 2P9

Southlake Regional Health Centre - Stronach Regional Cancer Centre, Newmarket

L1G 2B9

R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa

J4V 2H1

Centre intégré de santé et de services sociaux de la Montérégie Centre, Greenfield Park

H1M 1B1

Montreal Oncology Research Inc., Montreal

H4A 3J1

McGill University Health Centre, Montreal

H3P 3H5

Biron (Clinique René Laennec), Mount Royal

703 84

Vitkovicka nemocnice, a.s., Plicni oddeleni, Ostrava

401 13

Krajska zdravotni a.s. Masarykova nemocnice o.z., Ústí nad Labem

06189

Centre Antoine Lacassagne, Nice

00128

Policlinico Universitario Campus Bio-Medico, Roma

Unknown

Ain Wazein Hospital, Ain Wazein

American University of Beirut Medical Center, Beirut

Hotel Dieu de France, Beirut

Centre Hospitalier Universitaire Notre Dame de Secours, Byblos

Hammoud Hospital University Medical Center, Sidon

1066 CX

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam

2134 TM

Spaarne Gasthuis, Hoofddorp

6229 HX

MUMC, Maastricht

5504 DB

Maxima Medisch Centrum, Veldhoven

15-027

Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem, Bialystok

81-519

Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii, Gdynia

05-400

Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym, Otwock

60-569

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii, Poznan

1400-038

Centro Clínico Champalimaud - Fundação Champalimaud, Lisbon

1769-001

Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente, Lisbon

4099-001

Centro Hospitalar do Porto, EPE - Hospital de Santo António, Porto

4100-180

Hospital CUF Porto, Porto

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto

4200-319

Centro Hospitalar de São João, EPE, Porto

08916

Hospital Universitari Germans Trias i Pujol ICO, Badalona

08208

Corporació Sanitaria Parc Taulí-Hospital de Sabadell, Sabadell

08035

Hospital Universitari Vall d' Hebron, Barcelona

M20 4BX

The Christie NHS Fundation Trust, Manchester

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington

BS2 8ED

Bristol Cancer Institute, UHB NHS Foundation Trust, Bristol

NW1 2PG

University College London Hospitals NHS Foundation Trust, London

W1G 6AD

Sarah Cannon Research Institute UK, London

WR5 1DO

Worcestershire Acute Hospitals NHS Trust, Worcester

Sponsors

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PharmaMar

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