Klinisk utprøving av Lurbinectedin som enkeltmiddel eller i kombinasjon med irinotecan versus topotecan eller irinotecan hos pasienter med residiverende småcellet lungekreft (LAGOON)
En randomisert, multisenter, åpen fase III-studie av Lurbinectedin Single-Agent eller Lurbinectedin i kombinasjon med Irinotecan Versus Investigator's Choice (Topotecan eller Irinotecan) hos residiverende småcellet lungekreftpasienter (LAGOON Trial)
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Frenchs Forest, Australia, NSW 2086
- Northern Beaches Hospital
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Gosford, Australia, 2250
- Gosford Hospital GH - Central Coast Cancer Centre
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Heidelberg, Australia, VIC 3084
- Austin Hospital- Medical Oncology Unit
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Murdoch, Australia, WA 6150
- St John of God Murdoch Hospital
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Wollongong, Australia, NSW 2500
- Cancer Care Wollongong
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- The Chris Obrien Lifehouse
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Victoria
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Ballarat Central, Victoria, Australia, 3350
- BRICC - Ballarat Health Services
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Box Hill, Victoria, Australia, 3128
- Box Hill Hospital Eastern Health Clinical School
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Brasschaat, Belgia, 2930
- Algemeen Ziekenhuis AZ Klina - Borstkliniek
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Charleroi, Belgia, 6000
- Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
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Liège, Belgia, 4000
- CHR de la Citadelle
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Liège, Belgia, 4000
- Centre Hospitalier Chretien CHC - MontLegia
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Liège, Belgia, 4000
- CHU Liege
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Mechelen, Belgia, 2800
- Az Sint Maarten Mechelen
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Mons, Belgia, 7000
- Centre Hospitalier Universitaire (CHU) Ambroise Pare
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Antwerp
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Edegem, Antwerp, Belgia, 2650
- Antwerp University Hospital
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Barretos, Brasil, SP 14784-400
- Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
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Ijuí, Brasil, 98700-00
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
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Rio de Janeiro, Brasil, 20231-050
- Instituto Nacional de Cancer - Ministrio da Sade
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Paraná
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Curitiba, Paraná, Brasil, 82305-100
- Oncocentro-Centro de Oncologia do Parana
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Porto Alegre
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Porto Alegre, Porto Alegre, Brasil, 90050-170
- Irmandade daSanta Casa de Misericordia de Porto Alegre
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Porto Alegre, Porto Alegre, Brasil, 90610-000
- Hospital Sao Lucas da PUCRS
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Santa Cecília, Porto Alegre, Brasil, RS 90035-903
- UPCO - Hospital de Clinicas de Porto Alegre
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Salvador
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Ondina, Salvador, Brasil, BA 40170-110
- Nucleo de Oncologia da Bahia - NOB
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Plovdiv, Bulgaria, 4000
- Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
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Sofia, Bulgaria, 1303
- Specialized hospital for active treatment of oncological diseases
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Sofia, Bulgaria, 1632
- Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
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Panagyurishte
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Panagyurishte, Panagyurishte, Bulgaria, 4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
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Montreal, Canada, H4A 3J1
- McGill University Health Centre (MUHC)
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Toronto, Canada, ON M5G 2C1
- University Health Network - Princess Margaret Hospital
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Hamilton Health Sciences -Juravinski Cancer Centre
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Newmarket, Ontario, Canada, L3Y 2P9
- Southlake Regional Health Centre
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Quebec
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Laval, Quebec, Canada, H7M 3L9
- Hôpital de la Cité-de-la- Santé
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Longueuil, Quebec, Canada, J4V 2H1
- CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne
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Santiago, Chile
- Hospital Clinico Universidad de Chile
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Santiago, Chile
- Clinica Alemana de Santiago
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Santiago, Chile
- Centro de Estudios Clínicos SAGA
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Santiago, Chile
- Clínica Santa María
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Santiago, Chile
- Fundación Arturo López Pérez
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Araucania
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Temuco, Araucania, Chile, 4780000
- James Lind Centro de Investigación del Cáncer
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Los Ríos Region
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Valdivia, Los Ríos Region, Chile, 5090000
- Clinical Research Chile SpA
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Aalborg, Danmark, 9000
- Aalborg University Hospital
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Næstved, Danmark, 4700
- Sjællands Universitetshospital
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Sønderborg, Danmark, 6400
- Sønderborg Sygehus
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Vejle, Danmark, 7100
- Vejle Hospital
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Ironwood Cancer & Research Centers
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Arkansas
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Hot Springs, Arkansas, Forente stater, 71913
- Genesis Cancer and Blood
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Florida Cancer Specialists - South
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St. Petersburg, Florida, Forente stater, 33705
- Florida Cancer Specialists - North
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Tallahassee, Florida, Forente stater, 32308
- Florida Cancer Specialists - Panhandle
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West Palm Beach, Florida, Forente stater, 33401
- Florida Cancer Specialists - East
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Illinois
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Joliet, Illinois, Forente stater, 60435
- Duly Health and Care
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Norton Cancer Institue, Downtown
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Dana-Farber Cancer Institute
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Nebraska
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Grand Island, Nebraska, Forente stater, 68803
- Oncology Hematology West, PC (Grand Island)
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Omaha, Nebraska, Forente stater, 68130
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
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North Carolina
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Pinehurst, North Carolina, Forente stater, 28374
- FirstHealth Outpatient Cancer Center
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Utah
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Salt Lake City, Utah, Forente stater, 84106
- Utah Cancer Specialists
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Washington
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Tacoma, Washington, Forente stater, 98405
- MultiCare Regional Cancer Center - Tacoma
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Froedtert Hospital/Medical College of Wisconsin
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Besançon, Frankrike, 25030
- Hopital Jean Minjoz
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Boulogne-Billancourt, Frankrike, 92100
- AssAP-HP - Hopital Ambroise-Pare
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Brest, Frankrike, 29200
- Hopital Morvan CHU de Brest
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Caen, Frankrike, 14000
- Centre François Baclesse
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Caen, Frankrike, 14033
- CHU de Caen - Hopital Cote de Nacre
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Créteil, Frankrike, 94000
- Centre Hospitalier Intercommunal de Creteil (CHIC)
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Limoges, Frankrike, 87000
- Centre Hospitalier Universitaire CHU De Limoges
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Nantes, Frankrike, Cedex 01 44093
- CHU de Nantes
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Paris, Frankrike, 75018
- Bichat-Claude Bernard Hospital
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Reims, Frankrike, 51092
- CHU Reims - Hpital Maison Blanche
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Strasbourg, Frankrike, 67091
- Hopital Civil / Nouvel Hopital Civil
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Suresnes, Frankrike, 92150
- Hospital Foch
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Villejuif, Frankrike, 94805
- Gustave Roussy
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Batumi, Georgia, 6000
- High Technology Hospital Medcenter
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Tbilisi, Georgia, 112
- Todua Clinic
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Tbilisi, Georgia, 114
- New Hospitals
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Tbilisi, Georgia, 179
- JSC Evex Hospitals "Caraps Medline"
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Tbilisi, Georgia, 186
- LTD Cancer Research Centre
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Tbilisi, Georgia, 156
- Institute Of Clinical Oncology
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Haifa, Israel, 3109601
- Rambam Health Care Campu
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center
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Ramat Gan, Israel
- The Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Alessandria, Italia, 15121
- A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
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Ancona, Italia, 60126
- Azienda Ospedaliero Universitaria delle Marche
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Aviano, Italia, 33081
- IRCCS Centro di Riferimento Oncologico
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Bologna, Italia, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
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Catania, Italia, 95125
- Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
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Cuneo, Italia, 12100
- A.O. Santa Croce e Carle, Ospedale Carle
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Florence, Italia, 50134
- AOU Careggi
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Genova, Italia, 16149
- ASL 3 Genovese Oncologia Medica Villa Scassi
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Milan, Italia, 20089
- IRCCS Istituto Clinico Humanitas - Cancer Center
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Naples, Italia, 80138
- Universita degli Studi della Campania Luigi Vanvitelli
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Novara, Italia, 28100
- Ospedale Maggiore di Novara
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Orbassano, Italia, 10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Padova, Italia, 35128
- Oncologia Medica II Istituto Oncologico Veneto IRCCS
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Piacenza, Italia, 29121
- Azienda USL di Piacenza
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Rionero in Vulture, Italia, 85028
- Irccs-Crob
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Roma, Italia, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico
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Roma, Italia, 00128
- IFO Regina Elena
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Sondrio, Italia, 23100
- ASST Valtellina e Alto Lario Ospedale di Sondrio
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Varese, Italia, 21100
- ASST Sette Laghi
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Aomori
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Hirosaki, Aomori, Japan, 036-8563
- Hirosaki University Hospital
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Fukuoka
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Fukuoka, Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital
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Miyagi
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Sendai, Miyagi, Japan, 980-0873
- Sendai Kousei Hospital
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Okayama-ken
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Kurashiki, Okayama-ken, Japan, 710-8602
- Ohara HealthCare Foundation Kurashiki Central Hospital
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Osaka
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Habikino, Osaka, Japan
- Osaka Habikino Medical Center
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Hirakata-shi, Osaka, Japan, 573-1191
- Kansai Medical University Hospital
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Izumi, Osaka, Japan, 594-0073
- Izumi City General Hospital
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Izumi, Osaka, Japan, 594-0073
- Kanagawa Cancer Center
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Kishiwada, Osaka, Japan, 596-8501
- Kishiwada City Hospital
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Tokyo
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Bunkyō-Ku, Tokyo, Japan
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Koto-Ku, Tokyo, Japan, 135-8550
- The Cancer Institute Hospital Of JFCR
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Shinjuku-Ku, Tokyo, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine
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Bialystok, Polen, 15-569
- II Klinika Chorob Pluc i Gruzlicy
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Gdynia, Polen, 81-519
- Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
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Lodz, Polen, 93-513
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii
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Lublin, Polen, 20-093
- Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
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Prabuty, Polen, 82-550
- Szpital Specjalistyczny w Prabutach Sp. z o.o
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Rzeszów, Polen, 35-021
- Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
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Tomaszów Mazowiecki, Polen, 97-200
- Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
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Baia Mare, Romania, 020945
- Sc Oncopremium Team Srl
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Cluj-Napoca, Romania, 400641
- Medisprof srl
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Craiova, Romania, 200385
- Oncolab SRL
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Craiova, Romania, 200746
- Centrul de Oncologie Sfantu Nectarie
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Ovidiu, Romania, 9005900
- Ovidius Clinical Hospital
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Timișoara, Romania, 300166
- Oncocenter Oncologie clinica S.R.L
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A Coruña
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A Coruña, A Coruña, Spania, 15009
- Hospital Teresa Herrera C.H.U.A.
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Barcelona
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Badalona, Barcelona, Spania, 08916
- Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
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Barcelona, Barcelona, Spania, 08035
- Hospital Universitari Vall d'Hebron
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L'Hospitalet de Llobregat, Barcelona, Spania, 08908
- Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
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Cantabria
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Santander, Cantabria, Spania, 39008
- Hospital Universitario Marqués de Valdecilla
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Córdoba
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Córdoba, Córdoba, Spania, 14004
- Hospital Universitario Reina Sofía
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Gran Canaria
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Las Palmas de Gran Canaria, Gran Canaria, Spania, 35016
- Complejo Hospitalario Materno-Insular de Gran Canaria
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Lugo
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Lugo, Lugo, Spania, 27003
- Hospital Universitario Lucus Augusti
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Madrid
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Madrid, Madrid, Spania, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Spania, 28007
- Hospital General Universitario Gregorio Marañón
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Madrid, Madrid, Spania, 28050
- Hospital Universitario HM Sanchinarro
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Madrid, Madrid, Spania, 28006
- Hospital Universitario La Paz
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Madrid, Madrid, Spania, 28033
- MD Anderson Cancer Center
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Madrid, Madrid, Spania, 28027
- Clínica Universidad de Navarra
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Madrid, Madrid, Spania, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Madrid, Spania, 28040
- Hospital Clínico San Carlos
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Madrid, Madrid, Spania, 28040
- Hospital Universitario Fundación Jimenez Díaz
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Málaga
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Málaga, Málaga, Spania, 29010
- Hospital Regional Universitario Málaga Hospital Civil
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Navarre
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Pamplona, Navarre, Spania, 31008
- Clínica Universidad de Navarra
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Pontevedra
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Vigo, Pontevedra, Spania, 36312
- Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
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Sevilla
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Seville, Sevilla, Spania, 41013
- Hospital Universitario Virgen del Rocío
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Valencia
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Valencia, Valencia, Spania, 46026
- Hospital Universitari i Politècnic La Fe
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Valladolid
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Valladolid, Valladolid, Spania, 47003
- Hospital Clínico Universitario de Valladolid
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Zaragoza
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Zaragoza, Zaragoza, Spania, 50009
- Hospital Clínico Universitario Lozano Bleza
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Belfast, Storbritannia, BT9 7AB
- Belfast Health and Social Care Trust
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Harlow, Storbritannia, CM20 1QX
- The Princess Alexandra Hospital
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London, Storbritannia, SE1 9RT
- Guys and St Thomas NHS Foundation Trust
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Manchester, Storbritannia, M20 4BX
- The Christie NHS Foundation Trust
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Metropolitan Borough of Wirral, Storbritannia, CH63 4JY
- Clatterbridge Hospital
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Nottingham, Storbritannia, NG5 1PB
- Nottingham University Hospitals NHS Trust
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Wolverhampton, Storbritannia, WV10 0QP
- The Royal Wolverhampton NHS Trust
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Basel, Sveits, 4031
- University Hospital Basel
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Bellinzona, Sveits, 6500
- Istituto Oncologico della Svizzera Italiana
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Frauenfeld, Sveits, 8501
- Spital Thurgau - Kantonspital Frauenfeld
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Lausanne, Sveits, 1011
- Centre Hospitalier Universitaire Vaudois
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Liestal, Sveits, 4410
- Kantonsspital Baselland
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Münsterlingen, Sveits, 8596
- Spital Thurgau - Kantonsspital Muensterlingen
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Villars-sur-Glâne, Sveits, 1752
- HFR Freiburg Kantonsspital
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Cheongju-si, Sør -Korea, 28644
- Chungbuk National University Hospital
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Gyeonggi-do, Sør -Korea, 13496
- CHA Bundang Medical Center, CHA University
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Gyeonggi-do, Sør -Korea, 16247
- The Catholic University of Korea, St.Vincents Hospital
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Incheon, Sør -Korea, 21565
- Gachon University Gil Medical Center
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Incheon, Sør -Korea, 22332
- Inha University Hospital
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Seoul, Sør -Korea, 05505
- Asan Medical Center
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Seoul, Sør -Korea, 03181
- Kangbuk Samsung Hospital
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Seoul, Sør -Korea, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Sør -Korea, 07061
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
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Taipei, Taiwan, 106
- National Taiwan University Cancer Center
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Chang Hua
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Chang-hua, Chang Hua, Taiwan, 500
- Changhua Christian Hospital
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Chiayi
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Dalin, Chiayi, Taiwan, 622401
- Buddhist Dalin Tzu Chi Hospital
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Kaohsiung
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Kaohsiung City, Kaohsiung, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Adana
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Seyhan, Adana, Tyrkia (Türkiye), 01140
- Medicalpark Seyhan Hospital
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Ankara
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Çankaya, Ankara, Tyrkia (Türkiye), 06680
- Liv Hospital Ankara
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Istanbul
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Bağcılar, Istanbul, Tyrkia (Türkiye), 34214
- Bagcilar Medipol Mega University Hospital
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Kadıköy, Istanbul, Tyrkia (Türkiye), 34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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Kocaeli
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İzmit, Kocaeli, Tyrkia (Türkiye), 41380
- Kocaeli University Hospital
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Bad Berka, Tyskland, 99437
- Zentralklinik Bad Berka GmbH
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Berlin, Tyskland, 13125
- Evangelische Lungenklinik Berlin
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Bremen, Tyskland, 28325
- Klinikum Bremen Ost
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Duisburg, Tyskland, 74166
- Helios St. Johannes Klinikum
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Esslingen am Neckar, Tyskland, 73730
- Klinikum Esslingen GmbH
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Freiburg im Breisgau, Tyskland, 79106
- Universittsklinikum Freiburg
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Gauting, Tyskland, 82131
- Asklepios Fachklinik München-Gauting
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Halle, Tyskland, 06120
- Universitaetsklinikum Halle Saale
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Halle, Tyskland, 06120
- Krankenhaus Martha-Maria Halle gGmbH
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Heidelberg, Tyskland, 69126
- Thoraxclinic Heidelberg GmbH
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Karlsruhe, Tyskland, 76137
- Vincentius-Diakonissen-Kliniken gAG Karlsruhe
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Kassel, Tyskland, 34125
- Klinikum Kassel - Medizinische Klinik IV
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Löwenstein, Tyskland, 74245
- Klinik Loewenstein gGmbH
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Mannheim, Tyskland, 68167
- Universitaetsmedizin Mannheim
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München, Tyskland, 81925
- Staedtisches Klinikum München - Bogenhausen
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Offenbach, Tyskland, 63069
- Sana Klinikum Offenbach
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Schleswig-Holstein
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Großhansdorf, Schleswig-Holstein, Tyskland, 22927
- LungenClinic Grosshansdorf
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Debrecen, Ungarn, 4032
- Debreceni Egyetem - Klinikai Kozpont
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Farkasgyepű, Ungarn, 8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
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Kecskemét, Ungarn, 6000
- Bacs-Kiskun County Hospital
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Szolnok, Ungarn, 5004
- Hetenyi G Korhaz, Onkologiai Kozpont
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Törökbálint, Ungarn, 2045
- Pulmonology Hospital Torokbalint
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Salzburg, Østerrike, A-5020
- University Hospital Salzburg
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Vienna, Østerrike, A-1090
- Medizinische Universitaet Wien
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
-
Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
-
Active or untreated CNS metastases and/or carcinomatous meningitis.
-
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.
-
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).
-
RT in more than 35% of the bone marrow.
-
History of previous bone marrow and/or stem cell transplantation and allogenic transplant.
-
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.
-
Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
-
History of allergy or hypersensitivity to any of the study drugs or any of their excipients.
-
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
Andre navn:
|
|
Eksperimentell: Lurbinectedin plus Irinotecan
Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle):
|
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
Andre navn:
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
Andre navn:
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 |
|
Aktiv komparator: Control arm
Best Investigator's choice prior to randomization between:
|
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: From the date of randomization to the date of death or last contact, up to 39 months
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival by IRC (Independent Review Committee)
Tidsramme: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
|
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
|
|
Progression-free survival by IA (Investigator Assessment)
Tidsramme: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
|
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
|
|
Overall response rate by IRC
Tidsramme: From the date of randomization to the date of death or last contact, up to 39 months
|
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
|
|
Overall response rate by IA
Tidsramme: From the date of randomization to the date of death or last contact, up to 39 months
|
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
|
|
Overall survival rate at 12 months
Tidsramme: At 12 months
|
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
|
|
Overall survival rate at 24 months
Tidsramme: At 24 months
|
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
|
|
Progression-free survival rate at 6 months by IRC
Tidsramme: At 6 months
|
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
|
|
Progression-free survival rate at 6 months by IA
Tidsramme: At 6 months
|
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
|
|
Progression-free survival rate at 12 months by IRC
Tidsramme: 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
|
|
Progression-free survival rate at 12 months by IA
Tidsramme: 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
Tidsramme: 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
|
|
Duration of response by IA
Tidsramme: 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
|
|
Patient-reported outcomes
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
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Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PM1183-C-008-21
Legemiddel- og utstyrsinformasjon, studiedokumenter
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