Spots Global Cancer Trial Database for Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
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Trial Identification
Brief Title: Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
Official Title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)
Study ID: NCT02566993
Conditions
Study Description
Brief Summary: Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.
Detailed Description: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of an experimental arm consisting of PM01183/DOX combination followed by PM01183 alone, if applicable vs. best Investigator's choice between CAV or topotecan as a control arm, in SCLC patients who failed one prior platinum-containing line but no more than one prior chemotherapy-containing line.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology, Birmingham, Alabama, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers, Chandler, Arizona, United States
St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare, Fullerton, California, United States
Loma Linda University Medica! Center, Loma Linda, California, United States
Innovative Clinical Research Institute (ICRI), Whittier, California, United States
Boca Raton Regional Hospital Lynn Cancer Institute, Boca Raton, Florida, United States
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Joliet Oncology-Hematology Associates, Ltd., Joliet, Illinois, United States
Healthcare Research Network III, LLC, Tinley Park, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Montgomery Cancer Center, Mount Sterling, Kentucky, United States
East Jefferson Hematology-Oncology Metairie Physicians Services, Inc, Metairie, Louisiana, United States
Anne Arundel Medical Center Oncology and Hematology, Annapolis, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
QUEST Research Institute, Royal Oak, Michigan, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital, Lebanon, New Hampshire, United States
Summit Medical Group, P.A., Florham Park, New Jersey, United States
FirstHealth Outpatient Cancer Center, Pinehurst, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa, Oklahoma, United States
Associates in Hematology and Oncology, P.C., Upland, Pennsylvania, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Tyler Hematology-Oncology PA, Tyler, Texas, United States
Medical Oncology Associates PS (dba Summit Cancer Centers), Spokane, Washington, United States
MultiCare Institute for Research & Innovation, Tacoma, Washington, United States
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Instituto Médico Especializado Alexander Fleming, C.a.b.a., Buenos Aires, Argentina
Centro para la Atención Integral del Paciente Oncológico (CAIPO), San Miguel de Tucumán, Tucumán, Argentina
Instituto Oncológico de Córdoba (IONC), Córdoba, , Argentina
CORI - Centro Oncológico Riojano Integral, La Rioja, , Argentina
ISIS Centro Especializado de Luce S.A., Santa Fe, , Argentina
Universitätsklinik für Innere Medizin III der PMU, Salzburg, , Austria
Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie, Wien, , Austria
AZ Maria Middelares, Gent, , Belgium
Clinique André Renard, Herstal, , Belgium
CHR de la citadelle, Liege, , Belgium
CHU de Liege - Sart Tilman, Liege, , Belgium
CHU Ambroise Paré, Mons, , Belgium
AZ Delta Campus Wilgenstraat, Roeselare, , Belgium
Nucleo de Oncologia da Bahia, Salvador, BA, Brazil
lOP- Instituto de oncologia do paraná, Curitiba, Paraná, Brazil
Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer, Rio de Janeiro, RJ, Brazil
Instituto COl de Pesquisa, Educação e Gestão, Rio de Janeiro, RJ, Brazil
Associação Hospital de Caridade de Ijuí, Ijui, RS, Brazil
lrmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, RS, Brazil
Hospital São Lucas da PUCRS, Porto Alegre, RS, Brazil
Hospital de clínicas de Porto alegre, Pôrto Alegre, RS, Brazil
Fundação PlO XII - Hospital de Câncer de Barretos, Barretos, São Paulo, Brazil
lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas, Sao Paulo, São Paulo, Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte, Panagyurishte, , Bulgaria
Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia, Sofia, , Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology, Sofia, , Bulgaria
Southlake Regional Health Centre - Stronach Regional Cancer Centre, Newmarket, Ontario, Canada
R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa, Ontario, Canada
Centre intégré de santé et de services sociaux de la Montérégie Centre, Greenfield Park, Quebec, Canada
Biron (Clinique René Laennec), Mont-Royal, Quebec, Canada
Montreal Oncology Research Inc., Montreal, Quebec, Canada
McGill University Health Centre, Montréal, Quebec, Canada
Vitkovicka nemocnice, a.s., Plicni oddeleni, Ostrava, , Czechia
Krajska zdravotni a.s. Masarykova nemocnice o.z., Usti nad Labem, , Czechia
Institut Bergonié, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Hospitalier Intercommunal de Créteil, Creteil, , France
Centre Hospitalier Lyon Sud - Service de Pneumologie, Lyon, , France
Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques, Marseille, , France
Centre Antoine Lacassagne, Nice Cedex 2, , France
CHU de Rennes Hôpital Pontchaillou, Rennes, , France
Central Clinic of Bad Berka, Bad Berka, , Germany
Vivantes Klinikum am Urban, Hämatologie und Onkologie, Berlin, , Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation, Freiburg, , Germany
Asklepios-Fachkliniken München Gauting, Gauting, , Germany
Center for Pneumology and Thoracic Surgery, Gerlingen, , Germany
Thoraxklinik Heidelberg GmbH, Heidelberg, , Germany
Lungenklinik Hemer, Hemer, , Germany
VIDIA Christliche Kliniken Karlsruhe, Karlsruhe, , Germany
Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz, Koblenz, , Germany
Onkologische Schwerpunktpraxis Leer-Emden, Leer, , Germany
Klinik Löwenstein gGmbH, Med. Klinik II Onkologie, Löwenstein, , Germany
Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim, Mannheim, , Germany
Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin, Minden, , Germany
University of Munich LMU, Dpt. of Medicine V, Munchen, , Germany
Städtisches Krankenhaus München Neuperlach, Munchen, , Germany
Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie, Munchen, , Germany
Klinikum Nürnberg Nord - Pneumologische Onkologie, Nuremberg, , Germany
Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie, Ulm, , Germany
Medizinische Klinik I, Wuppertal, , Germany
University General Hospital of Heraklion - General Hospital "Venizeleio", Heraklion, Crete, Greece
General Hospital of Chest Diseases of Athens "Sotiria", Athens, , Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic, Athens, , Greece
General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki, Thessaloniki, , Greece
Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia, Budapest, , Hungary
Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia, Budapest, , Hungary
Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály, Farkasgyepu, , Hungary
Mátrai Gyógyintézet, Bronchológia, Matrahaza, , Hungary
Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály, Miskolc, , Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály, Szekesfehervar, , Hungary
Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály, Szombathely, , Hungary
Szent Borbála Kórház, Pulmonológiai osztály, Tatabanya, , Hungary
Zala Megyei Kórház, Pulmonologia, Zalaegerszeg, , Hungary
ASST Grande Ospedale Metropolitano Niguarda, Milano, MI, Italy
IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico), Rionero in Vulture, PZ, Italy
Centro di Riferimento Oncologico di Aviano, Aviano, , Italy
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico, Catania, , Italy
AOU Maggiore della Carità - SC Oncologia, Novara, , Italy
Istituto Oncologico Veneto, Padova, , Italy
lRCCS-Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Policlinico Universitario Campus Bio-Medico, Roma, , Italy
ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio, Sondrio, , Italy
Ain Wazein Hospital, Ain Wazein, El Chouf, Lebanon
American University of Beirut Medical Center, Beirut, , Lebanon
Hotel Dieu de France, Beirut, , Lebanon
Centre Hospitalier Universitaire Notre Dame de Secours, Biblos, , Lebanon
Hammoud Hospital University Medical Center, Sidon, , Lebanon
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
MUMC, Maastricht, , Netherlands
Maxima Medisch Centrum, Veldhoven, , Netherlands
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem, Białystok, , Poland
Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii, Gdynia, , Poland
Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym, Otwock, , Poland
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii, Poznań, , Poland
Centro Clínico Champalimaud - Fundação Champalimaud, Lisboa, , Portugal
Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente, Lisboa, , Portugal
Centro Hospitalar do Porto, EPE - Hospital de Santo António, Porto, , Portugal
Hospital CUF Porto, Porto, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto, , Portugal
Centro Hospitalar de São João, EPE, Porto, , Portugal
SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala, Craiova, Dolj, Romania
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei", Constanta, Judet Constanta, Romania
SC Oncolab SRL, Craiova, Judet Dolj, Romania
Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala, Baia Mare, Maramures, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala, Cluj, , Romania
Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala, Cluj, , Romania
Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala, Cluj, , Romania
Hospital Universitari Germans Trias i Pujol ICO, Badalona, Barcelona, Spain
Corporació Sanitaria Parc Taulí-Hospital de Sabadell, Sabadell, Barcelona, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Hospital Universitari Vall d' Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Clínico San Carlos, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Complejo hospitalario regional virgen rocío, Sevilla, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Universitario La Fe de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
The Christie NHS Fundation Trust, Manchester, Greater Manchester, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, United Kingdom
Bristol Cancer Institute, UHB NHS Foundation Trust, Bristol, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
Worcestershire Acute Hospitals NHS Trust, Worcester, , United Kingdom
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