Клинические испытания лурбинектина в качестве монотерапии или в комбинации с иринотеканом в сравнении с топотеканом или иринотеканом у пациентов с рецидивом мелкоклеточного рака легкого (LAGOON)
Рандомизированное многоцентровое открытое исследование фазы III монотерапии лурбинектином или лурбинектина в комбинации с иринотеканом в сравнении с выбором исследователя (топотекан или иринотекан) у пациентов с рецидивом мелкоклеточного рака легкого (исследование LAGOON)
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
Обзор исследования
Статус
Подробное описание
Approximately 705 Adult SCLC patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 who have failed one prior platinum-containing line with CTFI ≥ 30 days and controlled asymptomatic and pretreated Central Nervous System metastases will be enrolled and assigned to each treatment arm.
Central randomization will be implemented; patients will be assigned to each treatment arm at a 1:1:1 ratio.
An Independent Data Monitoring Committee (IDMC) will oversee the conduct of the study. The IDMC should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Frenchs Forest, Австралия, NSW 2086
- Northern Beaches Hospital
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Gosford, Австралия, 2250
- Gosford Hospital GH - Central Coast Cancer Centre
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Heidelberg, Австралия, VIC 3084
- Austin Hospital- Medical Oncology Unit
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Murdoch, Австралия, WA 6150
- St John of God Murdoch Hospital
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Wollongong, Австралия, NSW 2500
- Cancer Care Wollongong
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New South Wales
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Camperdown, New South Wales, Австралия, 2050
- The Chris Obrien Lifehouse
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Victoria
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Ballarat Central, Victoria, Австралия, 3350
- BRICC - Ballarat Health Services
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Box Hill, Victoria, Австралия, 3128
- Box Hill Hospital Eastern Health Clinical School
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Salzburg, Австрия, A-5020
- University Hospital Salzburg
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Vienna, Австрия, A-1090
- Medizinische Universitaet Wien
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Brasschaat, Бельгия, 2930
- Algemeen Ziekenhuis AZ Klina - Borstkliniek
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Charleroi, Бельгия, 6000
- Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
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Liège, Бельгия, 4000
- CHR de la Citadelle
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Liège, Бельгия, 4000
- Centre Hospitalier Chretien CHC - MontLegia
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Liège, Бельгия, 4000
- CHU Liege
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Mechelen, Бельгия, 2800
- Az Sint Maarten Mechelen
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Mons, Бельгия, 7000
- Centre Hospitalier Universitaire (CHU) Ambroise Pare
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Antwerp
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Edegem, Antwerp, Бельгия, 2650
- Antwerp University Hospital
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Plovdiv, Болгария, 4000
- Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
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Sofia, Болгария, 1303
- Specialized hospital for active treatment of oncological diseases
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Sofia, Болгария, 1632
- Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
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Panagyurishte
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Panagyurishte, Panagyurishte, Болгария, 4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
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Barretos, Бразилия, SP 14784-400
- Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
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Ijuí, Бразилия, 98700-00
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
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Rio de Janeiro, Бразилия, 20231-050
- Instituto Nacional de Cancer - Ministrio da Sade
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Paraná
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Curitiba, Paraná, Бразилия, 82305-100
- Oncocentro-Centro de Oncologia do Parana
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Porto Alegre
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Porto Alegre, Porto Alegre, Бразилия, 90050-170
- Irmandade daSanta Casa de Misericordia de Porto Alegre
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Porto Alegre, Porto Alegre, Бразилия, 90610-000
- Hospital Sao Lucas da PUCRS
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Santa Cecília, Porto Alegre, Бразилия, RS 90035-903
- UPCO - Hospital de Clinicas de Porto Alegre
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Salvador
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Ondina, Salvador, Бразилия, BA 40170-110
- Nucleo de Oncologia da Bahia - NOB
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Debrecen, Венгрия, 4032
- Debreceni Egyetem - Klinikai Kozpont
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Farkasgyepű, Венгрия, 8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
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Kecskemét, Венгрия, 6000
- Bacs-Kiskun County Hospital
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Szolnok, Венгрия, 5004
- Hetenyi G Korhaz, Onkologiai Kozpont
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Törökbálint, Венгрия, 2045
- Pulmonology Hospital Torokbalint
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Bad Berka, Германия, 99437
- Zentralklinik Bad Berka GmbH
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Berlin, Германия, 13125
- Evangelische Lungenklinik Berlin
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Bremen, Германия, 28325
- Klinikum Bremen Ost
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Duisburg, Германия, 74166
- Helios St. Johannes Klinikum
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Esslingen am Neckar, Германия, 73730
- Klinikum Esslingen GmbH
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Freiburg im Breisgau, Германия, 79106
- Universittsklinikum Freiburg
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Gauting, Германия, 82131
- Asklepios Fachklinik München-Gauting
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Halle, Германия, 06120
- Universitaetsklinikum Halle Saale
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Halle, Германия, 06120
- Krankenhaus Martha-Maria Halle gGmbH
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Heidelberg, Германия, 69126
- Thoraxclinic Heidelberg GmbH
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Karlsruhe, Германия, 76137
- Vincentius-Diakonissen-Kliniken gAG Karlsruhe
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Kassel, Германия, 34125
- Klinikum Kassel - Medizinische Klinik IV
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Löwenstein, Германия, 74245
- Klinik Loewenstein gGmbH
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Mannheim, Германия, 68167
- Universitaetsmedizin Mannheim
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München, Германия, 81925
- Staedtisches Klinikum München - Bogenhausen
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Offenbach, Германия, 63069
- Sana Klinikum Offenbach
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Schleswig-Holstein
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Großhansdorf, Schleswig-Holstein, Германия, 22927
- LungenClinic Grosshansdorf
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Batumi, Грузия, 6000
- High Technology Hospital Medcenter
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Tbilisi, Грузия, 112
- Todua Clinic
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Tbilisi, Грузия, 114
- New Hospitals
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Tbilisi, Грузия, 179
- JSC Evex Hospitals "Caraps Medline"
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Tbilisi, Грузия, 186
- LTD Cancer Research Centre
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Tbilisi, Грузия, 156
- Institute Of Clinical Oncology
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Aalborg, Дания, 9000
- Aalborg University Hospital
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Næstved, Дания, 4700
- Sjællands Universitetshospital
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Sønderborg, Дания, 6400
- Sønderborg Sygehus
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Vejle, Дания, 7100
- Vejle Hospital
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Haifa, Израиль, 3109601
- Rambam Health Care Campu
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Jerusalem, Израиль, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, Израиль, 49100
- Rabin Medical Center
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Ramat Gan, Израиль
- The Chaim Sheba Medical Center
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Tel Aviv, Израиль, 6423906
- Tel Aviv Sourasky Medical Center
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A Coruña
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A Coruña, A Coruña, Испания, 15009
- Hospital Teresa Herrera C.H.U.A.
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Barcelona
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Badalona, Barcelona, Испания, 08916
- Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
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Barcelona, Barcelona, Испания, 08035
- Hospital Universitari Vall d'Hebron
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L'Hospitalet de Llobregat, Barcelona, Испания, 08908
- Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
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Cantabria
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Santander, Cantabria, Испания, 39008
- Hospital Universitario Marqués de Valdecilla
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Córdoba
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Córdoba, Córdoba, Испания, 14004
- Hospital Universitario Reina Sofía
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Gran Canaria
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Las Palmas de Gran Canaria, Gran Canaria, Испания, 35016
- Complejo Hospitalario Materno-Insular de Gran Canaria
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Lugo
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Lugo, Lugo, Испания, 27003
- Hospital Universitario Lucus Augusti
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Madrid
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Madrid, Madrid, Испания, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Испания, 28007
- Hospital General Universitario Gregorio Marañón
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Madrid, Madrid, Испания, 28050
- Hospital Universitario HM Sanchinarro
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Madrid, Madrid, Испания, 28006
- Hospital Universitario La Paz
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Madrid, Madrid, Испания, 28033
- MD Anderson Cancer Center
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Madrid, Madrid, Испания, 28027
- Clínica Universidad de Navarra
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Madrid, Madrid, Испания, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Madrid, Испания, 28040
- Hospital Clínico San Carlos
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Madrid, Madrid, Испания, 28040
- Hospital Universitario Fundación Jimenez Díaz
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Málaga
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Málaga, Málaga, Испания, 29010
- Hospital Regional Universitario Málaga Hospital Civil
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Navarre
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Pamplona, Navarre, Испания, 31008
- Clínica Universidad de Navarra
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Pontevedra
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Vigo, Pontevedra, Испания, 36312
- Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
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Sevilla
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Seville, Sevilla, Испания, 41013
- Hospital Universitario Virgen del Rocío
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Valencia
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Valencia, Valencia, Испания, 46026
- Hospital Universitari i Politècnic La Fe
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Valladolid
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Valladolid, Valladolid, Испания, 47003
- Hospital Clínico Universitario de Valladolid
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Zaragoza
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Zaragoza, Zaragoza, Испания, 50009
- Hospital Clínico Universitario Lozano Bleza
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Alessandria, Италия, 15121
- A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
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Ancona, Италия, 60126
- Azienda Ospedaliero Universitaria delle Marche
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Aviano, Италия, 33081
- IRCCS Centro di Riferimento Oncologico
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Bologna, Италия, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
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Catania, Италия, 95125
- Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
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Cuneo, Италия, 12100
- A.O. Santa Croce e Carle, Ospedale Carle
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Florence, Италия, 50134
- AOU Careggi
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Genova, Италия, 16149
- ASL 3 Genovese Oncologia Medica Villa Scassi
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Milan, Италия, 20089
- IRCCS Istituto Clinico Humanitas - Cancer Center
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Naples, Италия, 80138
- Universita degli Studi della Campania Luigi Vanvitelli
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Novara, Италия, 28100
- Ospedale Maggiore di Novara
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Orbassano, Италия, 10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Padova, Италия, 35128
- Oncologia Medica II Istituto Oncologico Veneto IRCCS
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Piacenza, Италия, 29121
- Azienda USL di Piacenza
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Rionero in Vulture, Италия, 85028
- Irccs-Crob
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Roma, Италия, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico
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Roma, Италия, 00128
- IFO Regina Elena
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Sondrio, Италия, 23100
- ASST Valtellina e Alto Lario Ospedale di Sondrio
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Varese, Италия, 21100
- ASST Sette Laghi
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Montreal, Канада, H4A 3J1
- McGill University Health Centre (MUHC)
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Toronto, Канада, ON M5G 2C1
- University Health Network - Princess Margaret Hospital
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Ontario
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Hamilton, Ontario, Канада, L8V 5C2
- Hamilton Health Sciences -Juravinski Cancer Centre
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Newmarket, Ontario, Канада, L3Y 2P9
- Southlake Regional Health Centre
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Quebec
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Laval, Quebec, Канада, H7M 3L9
- Hôpital de la Cité-de-la- Santé
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Longueuil, Quebec, Канада, J4V 2H1
- CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne
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Bialystok, Польша, 15-569
- II Klinika Chorob Pluc i Gruzlicy
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Gdynia, Польша, 81-519
- Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
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Lodz, Польша, 93-513
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii
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Lublin, Польша, 20-093
- Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
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Prabuty, Польша, 82-550
- Szpital Specjalistyczny w Prabutach Sp. z o.o
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Rzeszów, Польша, 35-021
- Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
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Tomaszów Mazowiecki, Польша, 97-200
- Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
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Baia Mare, Румыния, 020945
- Sc Oncopremium Team Srl
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Cluj-Napoca, Румыния, 400641
- Medisprof srl
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Craiova, Румыния, 200385
- Oncolab SRL
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Craiova, Румыния, 200746
- Centrul de Oncologie Sfantu Nectarie
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Ovidiu, Румыния, 9005900
- Ovidius Clinical Hospital
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Timișoara, Румыния, 300166
- Oncocenter Oncologie clinica S.R.L
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Belfast, Соединенное Королевство, BT9 7AB
- Belfast Health and Social Care Trust
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Harlow, Соединенное Королевство, CM20 1QX
- The Princess Alexandra Hospital
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London, Соединенное Королевство, SE1 9RT
- Guys and St Thomas NHS Foundation Trust
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Manchester, Соединенное Королевство, M20 4BX
- The Christie NHS Foundation Trust
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Metropolitan Borough of Wirral, Соединенное Королевство, CH63 4JY
- Clatterbridge Hospital
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Nottingham, Соединенное Королевство, NG5 1PB
- Nottingham University Hospitals NHS Trust
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Wolverhampton, Соединенное Королевство, WV10 0QP
- The Royal Wolverhampton NHS Trust
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Arizona
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Chandler, Arizona, Соединенные Штаты, 85224
- Ironwood Cancer & Research Centers
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Arkansas
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Hot Springs, Arkansas, Соединенные Штаты, 71913
- Genesis Cancer and Blood
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Florida
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Fort Myers, Florida, Соединенные Штаты, 33901
- Florida Cancer Specialists - South
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St. Petersburg, Florida, Соединенные Штаты, 33705
- Florida Cancer Specialists - North
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Tallahassee, Florida, Соединенные Штаты, 32308
- Florida Cancer Specialists - Panhandle
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West Palm Beach, Florida, Соединенные Штаты, 33401
- Florida Cancer Specialists - East
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Illinois
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Joliet, Illinois, Соединенные Штаты, 60435
- Duly Health and Care
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40202
- Norton Cancer Institue, Downtown
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02215
- Dana-Farber Cancer Institute
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Nebraska
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Grand Island, Nebraska, Соединенные Штаты, 68803
- Oncology Hematology West, PC (Grand Island)
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Omaha, Nebraska, Соединенные Штаты, 68130
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
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North Carolina
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Pinehurst, North Carolina, Соединенные Штаты, 28374
- FirstHealth Outpatient Cancer Center
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84106
- Utah Cancer Specialists
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Washington
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Tacoma, Washington, Соединенные Штаты, 98405
- MultiCare Regional Cancer Center - Tacoma
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Wisconsin
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- Froedtert Hospital/Medical College of Wisconsin
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Taipei, Тайвань, 106
- National Taiwan University Cancer Center
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Chang Hua
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Chang-hua, Chang Hua, Тайвань, 500
- Changhua Christian Hospital
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Chiayi
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Dalin, Chiayi, Тайвань, 622401
- Buddhist Dalin Tzu Chi Hospital
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Kaohsiung
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Kaohsiung City, Kaohsiung, Тайвань, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Adana
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Seyhan, Adana, Турция (Туркие), 01140
- Medicalpark Seyhan Hospital
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Ankara
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Çankaya, Ankara, Турция (Туркие), 06680
- Liv Hospital Ankara
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Istanbul
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Bağcılar, Istanbul, Турция (Туркие), 34214
- Bagcilar Medipol Mega University Hospital
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Kadıköy, Istanbul, Турция (Туркие), 34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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Kocaeli
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İzmit, Kocaeli, Турция (Туркие), 41380
- Kocaeli University Hospital
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Besançon, Франция, 25030
- Hopital Jean Minjoz
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Boulogne-Billancourt, Франция, 92100
- AssAP-HP - Hopital Ambroise-Pare
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Brest, Франция, 29200
- Hopital Morvan CHU de Brest
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Caen, Франция, 14000
- Centre François Baclesse
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Caen, Франция, 14033
- CHU de Caen - Hopital Cote de Nacre
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Créteil, Франция, 94000
- Centre Hospitalier Intercommunal de Creteil (CHIC)
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Limoges, Франция, 87000
- Centre Hospitalier Universitaire CHU De Limoges
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Nantes, Франция, Cedex 01 44093
- CHU de Nantes
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Paris, Франция, 75018
- Bichat-Claude Bernard Hospital
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Reims, Франция, 51092
- CHU Reims - Hpital Maison Blanche
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Strasbourg, Франция, 67091
- Hopital Civil / Nouvel Hopital Civil
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Suresnes, Франция, 92150
- Hospital Foch
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Villejuif, Франция, 94805
- Gustave Roussy
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Santiago, Чили
- Hospital Clinico Universidad de Chile
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Santiago, Чили
- Clinica Alemana de Santiago
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Santiago, Чили
- Centro de Estudios Clínicos SAGA
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Santiago, Чили
- Clínica Santa María
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Santiago, Чили
- Fundación Arturo López Pérez
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Araucania
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Temuco, Araucania, Чили, 4780000
- James Lind Centro de Investigación del Cáncer
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Los Ríos Region
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Valdivia, Los Ríos Region, Чили, 5090000
- Clinical Research Chile SpA
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Basel, Швейцария, 4031
- University Hospital Basel
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Bellinzona, Швейцария, 6500
- Istituto Oncologico della Svizzera Italiana
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Frauenfeld, Швейцария, 8501
- Spital Thurgau - Kantonspital Frauenfeld
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Lausanne, Швейцария, 1011
- Centre Hospitalier Universitaire Vaudois
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Liestal, Швейцария, 4410
- Kantonsspital Baselland
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Münsterlingen, Швейцария, 8596
- Spital Thurgau - Kantonsspital Muensterlingen
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Villars-sur-Glâne, Швейцария, 1752
- HFR Freiburg Kantonsspital
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Cheongju-si, Южная Корея, 28644
- Chungbuk National University Hospital
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Gyeonggi-do, Южная Корея, 13496
- CHA Bundang Medical Center, CHA University
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Gyeonggi-do, Южная Корея, 16247
- The Catholic University of Korea, St.Vincents Hospital
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Incheon, Южная Корея, 21565
- Gachon University Gil Medical Center
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Incheon, Южная Корея, 22332
- Inha University Hospital
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Seoul, Южная Корея, 05505
- Asan Medical Center
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Seoul, Южная Корея, 03181
- Kangbuk Samsung Hospital
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Seoul, Южная Корея, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Южная Корея, 07061
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
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-
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Aomori
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Hirosaki, Aomori, Япония, 036-8563
- Hirosaki University Hospital
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Fukuoka
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Fukuoka, Fukuoka, Япония, 812-8582
- Kyushu University Hospital
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Hyōgo
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Kobe, Hyōgo, Япония, 650-0047
- Kobe City Medical Center General Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Япония, 920-8641
- Kanazawa University Hospital
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Miyagi
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Sendai, Miyagi, Япония, 980-0873
- Sendai Kousei Hospital
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Okayama-ken
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Kurashiki, Okayama-ken, Япония, 710-8602
- Ohara HealthCare Foundation Kurashiki Central Hospital
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Osaka
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Habikino, Osaka, Япония
- Osaka Habikino Medical Center
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Hirakata-shi, Osaka, Япония, 573-1191
- Kansai Medical University Hospital
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Izumi, Osaka, Япония, 594-0073
- Izumi City General Hospital
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Izumi, Osaka, Япония, 594-0073
- Kanagawa Cancer Center
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Kishiwada, Osaka, Япония, 596-8501
- Kishiwada City Hospital
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Tokyo
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Bunkyō-Ku, Tokyo, Япония
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Koto-Ku, Tokyo, Япония, 135-8550
- The Cancer Institute Hospital Of JFCR
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Shinjuku-Ku, Tokyo, Япония, 162-8655
- Center Hospital of the National Center for Global Health and Medicine
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
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Voluntary written informed consent of the patient obtained before any study-specific procedure
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Age≥18 years
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Histologically or cytologically confirmed diagnosis of SCLC.
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One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
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Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days (independent of the immunotherapy maintenance, if applicable)
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Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment
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Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
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Adequate hematological, renal, metabolic and hepatic function:
- Hemoglobin ≥ 9.0 g/dL [patients may have received prior red blood cell (RBC) transfusion, if clinically indicated]; absolute neutrophil count (ANC) ≥ 2.0 x 10^9/L, and platelet count ≥ 100 x 10^9/L.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN.
- Albumin ≥ 3.0 g/dL.
- Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula).
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At least three weeks since last prior antineoplastic treatment and recovery to grade ≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, immune-related hypothyroidism, anemia, asthenia and alopecia, all grade ≤ 2) according to the National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE) v.5.
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Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified.
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Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to seven months after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.
Exclusion Criteria:
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Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
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Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
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Active or untreated CNS metastases and/or carcinomatous meningitis.
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Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization.
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Concomitant diseases/conditions:
- History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
- Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
- Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.
- Known Gilbert's disease.
- Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture. Presence of external drainages.
- Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related antiviral therapy within six months prior to the first dose of study drugs will also be excluded.
- Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease or pulmonary fibrosis.
- Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma and who has been continuously in remission since then will be permitted.
- Limitation of the patient's ability to comply with the treatment or to follow the protocol.
- Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
- Known human immunodeficiency virus (HIV) infection.
- Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or subocclusion or paralysis.
- Evident symptomatic pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
- Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g.; COVID-19 disease).
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RT in more than 35% of the bone marrow.
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History of previous bone marrow and/or stem cell transplantation and allogenic transplant.
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Patient has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of inactivated vaccines is allowed.
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Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
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History of allergy or hypersensitivity to any of the study drugs or any of their excipients.
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Women who are pregnant or breast feeding and fertile patients (men and women) who are not able to use a highly effective method of contraception
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Lurbinectedin
Patients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle) |
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
Другие имена:
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
Другие имена:
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Экспериментальный: Lurbinectedin plus Irinotecan
Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle):
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Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
Другие имена:
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
Другие имена:
Irinotecan 75 mg/m² intravenously Days 1 & 8 q3wk For patients aged <70 years: irinotecan 350 mg/m² intravenously Day 1 q3wk For patients aged ≥70 years: irinotecan 300 mg/m² intravenously Day 1 q3wk |
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Активный компаратор: Control arm
Best Investigator's choice prior to randomization between:
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Irinotecan 75 mg/m² intravenously Days 1 & 8 q3wk For patients aged <70 years: irinotecan 350 mg/m² intravenously Day 1 q3wk For patients aged ≥70 years: irinotecan 300 mg/m² intravenously Day 1 q3wk Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Overall survival
Временное ограничение: From the date of randomization to the date of death or last contact, up to 39 months
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Overall survival (OS) will be calculated from the date of randomization to the date of death or last contact (in this case, survival will be censored on that date). |
From the date of randomization to the date of death or last contact, up to 39 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Progression-free survival by IRC (Independent Review Committee)
Временное ограничение: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
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Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease ≥ 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy. |
From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
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Progression-free survival by IA (Investigator Assessment)
Временное ограничение: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
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Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease ≥ 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy. |
From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
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Overall response rate by IRC
Временное ограничение: From the date of randomization to the date of death or last contact, up to 39 months
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Overall response rate (ORR) will be the percentage of patients with complete or partial response as the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. |
From the date of randomization to the date of death or last contact, up to 39 months
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Overall response rate by IA
Временное ограничение: From the date of randomization to the date of death or last contact, up to 39 months
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Overall response rate (ORR) will be the percentage of patients with complete or partial response as the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. |
From the date of randomization to the date of death or last contact, up to 39 months
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Overall survival rate at 12 months
Временное ограничение: At 12 months
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Overall survival rate at 12 months is defined as the percentage of people who are still alive at 12 months after randomization. |
At 12 months
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Overall survival rate at 24 months
Временное ограничение: At 24 months
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Overall survival rate at 24 months is defined as the percentage of people who are still alive at 24 months after randomization. |
At 24 months
|
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Progression-free survival rate at 6 months by IRC
Временное ограничение: At 6 months
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Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization |
At 6 months
|
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Progression-free survival rate at 6 months by IA
Временное ограничение: At 6 months
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Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization |
At 6 months
|
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Progression-free survival rate at 12 months by IRC
Временное ограничение: At 12 months
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Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization |
At 12 months
|
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Progression-free survival rate at 12 months by IA
Временное ограничение: At 12 months
|
Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization |
At 12 months
|
|
Duration of response by IRC
Временное ограничение: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
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Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. |
From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
|
|
Duration of response by IA
Временное ограничение: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
|
Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. |
From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
|
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Patient-reported outcomes
Временное ограничение: At baseline and every six weeks (± one week) until end of treatment, up to 39 months
|
To measure the quality of life of patients, the Lung Cancer Symptom Scale (LCSS) questionnaire will be analyzed. |
At baseline and every six weeks (± one week) until end of treatment, up to 39 months
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Легочные заболевания
- Новообразования дыхательных путей
- Грудные новообразования
- Новообразования легких
- Рак, Бронхогенный
- Бронхиальные новообразования
- Мелкоклеточная карцинома легкого
- Гетероциклические соединения
- Камптотекин
- Алкалоиды
- Иринотекан
- Топотекан
- PM 01183
Другие идентификационные номера исследования
- PM1183-C-008-21
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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