Lurbinectedin 作为单药或联合伊立替康与托泊替康或伊立替康在复发性小细胞肺癌患者中的临床试验 (LAGOON)
Lurbinectedin 单药或 Lurbinectedin 联合伊立替康与研究者选择（托泊替康或伊立替康）在复发性小细胞肺癌患者中的随机、多中心、开放标签 III 期研究（LAGOON 试验）
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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-
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Aalborg、丹麦、9000
- Aalborg University Hospital
-
Næstved、丹麦、4700
- Sjællands Universitetshospital
-
Sønderborg、丹麦、6400
- Sønderborg Sygehus
-
Vejle、丹麦、7100
- Vejle Hospital
-
-
-
-
-
Batumi、乔治亚州、6000
- High Technology Hospital Medcenter
-
Tbilisi、乔治亚州、112
- Todua Clinic
-
Tbilisi、乔治亚州、114
- New Hospitals
-
Tbilisi、乔治亚州、179
- JSC Evex Hospitals "Caraps Medline"
-
Tbilisi、乔治亚州、186
- LTD Cancer Research Centre
-
Tbilisi、乔治亚州、156
- Institute Of Clinical Oncology
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-
-
-
-
Haifa、以色列、3109601
- Rambam Health Care Campu
-
Jerusalem、以色列、9103102
- Shaare Zedek Medical Center
-
Petah Tikva、以色列、49100
- Rabin Medical Center
-
Ramat Gan、以色列
- The Chaim Sheba Medical Center
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Tel Aviv、以色列、6423906
- Tel Aviv Sourasky Medical Center
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-
-
-
-
Plovdiv、保加利亚、4000
- Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
-
Sofia、保加利亚、1303
- Specialized hospital for active treatment of oncological diseases
-
Sofia、保加利亚、1632
- Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
-
-
Panagyurishte
-
Panagyurishte、Panagyurishte、保加利亚、4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
-
-
-
-
-
Montreal、加拿大、H4A 3J1
- McGill University Health Centre (MUHC)
-
Toronto、加拿大、ON M5G 2C1
- University Health Network - Princess Margaret Hospital
-
-
Ontario
-
Hamilton、Ontario、加拿大、L8V 5C2
- Hamilton Health Sciences -Juravinski Cancer Centre
-
Newmarket、Ontario、加拿大、L3Y 2P9
- Southlake Regional Health Centre
-
-
Quebec
-
Laval、Quebec、加拿大、H7M 3L9
- Hôpital de la Cité-de-la- Santé
-
Longueuil、Quebec、加拿大、J4V 2H1
- CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne
-
-
-
-
-
Debrecen、匈牙利、4032
- Debreceni Egyetem - Klinikai Kozpont
-
Farkasgyepű、匈牙利、8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
-
Kecskemét、匈牙利、6000
- Bacs-Kiskun County Hospital
-
Szolnok、匈牙利、5004
- Hetenyi G Korhaz, Onkologiai Kozpont
-
Törökbálint、匈牙利、2045
- Pulmonology Hospital Torokbalint
-
-
-
-
-
Taipei、台湾、106
- National Taiwan University Cancer Center
-
-
Chang Hua
-
Chang-hua、Chang Hua、台湾、500
- Changhua Christian Hospital
-
-
Chiayi
-
Dalin、Chiayi、台湾、622401
- Buddhist Dalin Tzu Chi Hospital
-
-
Kaohsiung
-
Kaohsiung City、Kaohsiung、台湾、83301
- Kaohsiung Chang Gung Memorial Hospital
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-
-
-
Adana
-
Seyhan、Adana、土耳其（türkiye）、01140
- Medicalpark Seyhan Hospital
-
-
Ankara
-
Çankaya、Ankara、土耳其（türkiye）、06680
- Liv Hospital Ankara
-
-
Istanbul
-
Bağcılar、Istanbul、土耳其（türkiye）、34214
- Bagcilar Medipol Mega University Hospital
-
Kadıköy、Istanbul、土耳其（türkiye）、34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
-
Kocaeli
-
İzmit、Kocaeli、土耳其（türkiye）、41380
- Kocaeli University Hospital
-
-
-
-
-
Salzburg、奥地利、A-5020
- University Hospital Salzburg
-
Vienna、奥地利、A-1090
- Medizinische Universitaet Wien
-
-
-
-
-
Barretos、巴西、SP 14784-400
- Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
-
Ijuí、巴西、98700-00
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
-
Rio de Janeiro、巴西、20231-050
- Instituto Nacional de Cancer - Ministrio da Sade
-
-
Paraná
-
Curitiba、Paraná、巴西、82305-100
- Oncocentro-Centro de Oncologia do Parana
-
-
Porto Alegre
-
Porto Alegre、Porto Alegre、巴西、90050-170
- Irmandade daSanta Casa de Misericordia de Porto Alegre
-
Porto Alegre、Porto Alegre、巴西、90610-000
- Hospital Sao Lucas da PUCRS
-
Santa Cecília、Porto Alegre、巴西、RS 90035-903
- UPCO - Hospital de Clinicas de Porto Alegre
-
-
Salvador
-
Ondina、Salvador、巴西、BA 40170-110
- Nucleo de Oncologia da Bahia - NOB
-
-
-
-
-
Bad Berka、德国、99437
- Zentralklinik Bad Berka GmbH
-
Berlin、德国、13125
- Evangelische Lungenklinik Berlin
-
Bremen、德国、28325
- Klinikum Bremen Ost
-
Duisburg、德国、74166
- Helios St. Johannes Klinikum
-
Esslingen am Neckar、德国、73730
- Klinikum Esslingen GmbH
-
Freiburg im Breisgau、德国、79106
- Universittsklinikum Freiburg
-
Gauting、德国、82131
- Asklepios Fachklinik München-Gauting
-
Halle、德国、06120
- Universitaetsklinikum Halle Saale
-
Halle、德国、06120
- Krankenhaus Martha-Maria Halle gGmbH
-
Heidelberg、德国、69126
- Thoraxclinic Heidelberg GmbH
-
Karlsruhe、德国、76137
- Vincentius-Diakonissen-Kliniken gAG Karlsruhe
-
Kassel、德国、34125
- Klinikum Kassel - Medizinische Klinik IV
-
Löwenstein、德国、74245
- Klinik Loewenstein gGmbH
-
Mannheim、德国、68167
- Universitaetsmedizin Mannheim
-
München、德国、81925
- Staedtisches Klinikum München - Bogenhausen
-
Offenbach、德国、63069
- Sana Klinikum Offenbach
-
-
Schleswig-Holstein
-
Großhansdorf、Schleswig-Holstein、德国、22927
- LungenClinic Grosshansdorf
-
-
-
-
-
Alessandria、意大利、15121
- A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
-
Ancona、意大利、60126
- Azienda Ospedaliero Universitaria delle Marche
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Aviano、意大利、33081
- IRCCS Centro di Riferimento Oncologico
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Bologna、意大利、40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
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Catania、意大利、95125
- Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
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Cuneo、意大利、12100
- A.O. Santa Croce e Carle, Ospedale Carle
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Florence、意大利、50134
- AOU Careggi
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Genova、意大利、16149
- ASL 3 Genovese Oncologia Medica Villa Scassi
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Milan、意大利、20089
- IRCCS Istituto Clinico Humanitas - Cancer Center
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Naples、意大利、80138
- Universita degli Studi della Campania Luigi Vanvitelli
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Novara、意大利、28100
- Ospedale Maggiore di Novara
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Orbassano、意大利、10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Padova、意大利、35128
- Oncologia Medica II Istituto Oncologico Veneto IRCCS
-
Piacenza、意大利、29121
- Azienda USL di Piacenza
-
Rionero in Vulture、意大利、85028
- Irccs-Crob
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Roma、意大利、00128
- Fondazione Policlinico Universitario Campus Bio-Medico
-
Roma、意大利、00128
- IFO Regina Elena
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Sondrio、意大利、23100
- ASST Valtellina e Alto Lario Ospedale di Sondrio
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Varese、意大利、21100
- ASST Sette Laghi
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-
-
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Aomori
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Hirosaki、Aomori、日本、036-8563
- Hirosaki University Hospital
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Fukuoka
-
Fukuoka、Fukuoka、日本、812-8582
- Kyushu University Hospital
-
-
Hyōgo
-
Kobe、Hyōgo、日本、650-0047
- Kobe City Medical Center General Hospital
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Ishikawa-ken
-
Kanazawa、Ishikawa-ken、日本、920-8641
- Kanazawa University Hospital
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-
Miyagi
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Sendai、Miyagi、日本、980-0873
- Sendai Kousei Hospital
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Okayama-ken
-
Kurashiki、Okayama-ken、日本、710-8602
- Ohara HealthCare Foundation Kurashiki Central Hospital
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Osaka
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Habikino、Osaka、日本
- Osaka Habikino Medical Center
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Hirakata-shi、Osaka、日本、573-1191
- Kansai Medical University Hospital
-
Izumi、Osaka、日本、594-0073
- Izumi City General Hospital
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Izumi、Osaka、日本、594-0073
- Kanagawa Cancer Center
-
Kishiwada、Osaka、日本、596-8501
- Kishiwada City Hospital
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-
Tokyo
-
Bunkyō-Ku、Tokyo、日本
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
-
Koto-Ku、Tokyo、日本、135-8550
- The Cancer Institute Hospital Of JFCR
-
Shinjuku-Ku、Tokyo、日本、162-8655
- Center Hospital of the National Center for Global Health and Medicine
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-
-
-
-
Santiago、智利
- Hospital Clinico Universidad de Chile
-
Santiago、智利
- Clinica Alemana de Santiago
-
Santiago、智利
- Centro de Estudios Clínicos SAGA
-
Santiago、智利
- Clínica Santa María
-
Santiago、智利
- Fundación Arturo López Pérez
-
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Araucania
-
Temuco、Araucania、智利、4780000
- James Lind Centro de Investigación del Cáncer
-
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Los Ríos Region
-
Valdivia、Los Ríos Region、智利、5090000
- Clinical Research Chile SpA
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-
-
-
-
Brasschaat、比利时、2930
- Algemeen Ziekenhuis AZ Klina - Borstkliniek
-
Charleroi、比利时、6000
- Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
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Liège、比利时、4000
- CHR de la Citadelle
-
Liège、比利时、4000
- Centre Hospitalier Chretien CHC - MontLegia
-
Liège、比利时、4000
- CHU Liege
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Mechelen、比利时、2800
- Az Sint Maarten Mechelen
-
Mons、比利时、7000
- Centre Hospitalier Universitaire (CHU) Ambroise Pare
-
-
Antwerp
-
Edegem、Antwerp、比利时、2650
- Antwerp University Hospital
-
-
-
-
-
Besançon、法国、25030
- Hopital Jean Minjoz
-
Boulogne-Billancourt、法国、92100
- AssAP-HP - Hopital Ambroise-Pare
-
Brest、法国、29200
- Hopital Morvan CHU de Brest
-
Caen、法国、14000
- Centre François Baclesse
-
Caen、法国、14033
- CHU de Caen - Hopital Cote de Nacre
-
Créteil、法国、94000
- Centre Hospitalier Intercommunal de Creteil (CHIC)
-
Limoges、法国、87000
- Centre Hospitalier Universitaire CHU De Limoges
-
Nantes、法国、Cedex 01 44093
- CHU de Nantes
-
Paris、法国、75018
- Bichat-Claude Bernard Hospital
-
Reims、法国、51092
- CHU Reims - Hpital Maison Blanche
-
Strasbourg、法国、67091
- Hopital Civil / Nouvel Hopital Civil
-
Suresnes、法国、92150
- Hospital Foch
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Villejuif、法国、94805
- Gustave Roussy
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-
-
-
-
Bialystok、波兰、15-569
- II Klinika Chorob Pluc i Gruzlicy
-
Gdynia、波兰、81-519
- Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
-
Lodz、波兰、93-513
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii
-
Lublin、波兰、20-093
- Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
-
Prabuty、波兰、82-550
- Szpital Specjalistyczny w Prabutach Sp. z o.o
-
Rzeszów、波兰、35-021
- Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
-
Tomaszów Mazowiecki、波兰、97-200
- Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
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-
-
-
-
Frenchs Forest、澳大利亚、NSW 2086
- Northern Beaches Hospital
-
Gosford、澳大利亚、2250
- Gosford Hospital GH - Central Coast Cancer Centre
-
Heidelberg、澳大利亚、VIC 3084
- Austin Hospital- Medical Oncology Unit
-
Murdoch、澳大利亚、WA 6150
- St John of God Murdoch Hospital
-
Wollongong、澳大利亚、NSW 2500
- Cancer Care Wollongong
-
-
New South Wales
-
Camperdown、New South Wales、澳大利亚、2050
- The Chris Obrien Lifehouse
-
-
Victoria
-
Ballarat Central、Victoria、澳大利亚、3350
- BRICC - Ballarat Health Services
-
Box Hill、Victoria、澳大利亚、3128
- Box Hill Hospital Eastern Health Clinical School
-
-
-
-
-
Basel、瑞士、4031
- University Hospital Basel
-
Bellinzona、瑞士、6500
- Istituto Oncologico della Svizzera Italiana
-
Frauenfeld、瑞士、8501
- Spital Thurgau - Kantonspital Frauenfeld
-
Lausanne、瑞士、1011
- Centre Hospitalier Universitaire Vaudois
-
Liestal、瑞士、4410
- Kantonsspital Baselland
-
Münsterlingen、瑞士、8596
- Spital Thurgau - Kantonsspital Muensterlingen
-
Villars-sur-Glâne、瑞士、1752
- HFR Freiburg Kantonsspital
-
-
-
-
-
Baia Mare、罗马尼亚、020945
- Sc Oncopremium Team Srl
-
Cluj-Napoca、罗马尼亚、400641
- Medisprof srl
-
Craiova、罗马尼亚、200385
- Oncolab SRL
-
Craiova、罗马尼亚、200746
- Centrul de Oncologie Sfantu Nectarie
-
Ovidiu、罗马尼亚、9005900
- Ovidius Clinical Hospital
-
Timișoara、罗马尼亚、300166
- Oncocenter Oncologie clinica S.R.L
-
-
-
-
Arizona
-
Chandler、Arizona、美国、85224
- Ironwood Cancer & Research Centers
-
-
Arkansas
-
Hot Springs、Arkansas、美国、71913
- Genesis Cancer and Blood
-
-
Florida
-
Fort Myers、Florida、美国、33901
- Florida Cancer Specialists - South
-
St. Petersburg、Florida、美国、33705
- Florida Cancer Specialists - North
-
Tallahassee、Florida、美国、32308
- Florida Cancer Specialists - Panhandle
-
West Palm Beach、Florida、美国、33401
- Florida Cancer Specialists - East
-
-
Illinois
-
Joliet、Illinois、美国、60435
- Duly Health and Care
-
-
Kentucky
-
Louisville、Kentucky、美国、40202
- Norton Cancer Institue, Downtown
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215
- Dana-Farber Cancer Institute
-
-
Nebraska
-
Grand Island、Nebraska、美国、68803
- Oncology Hematology West, PC (Grand Island)
-
Omaha、Nebraska、美国、68130
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
-
-
North Carolina
-
Pinehurst、North Carolina、美国、28374
- FirstHealth Outpatient Cancer Center
-
-
Utah
-
Salt Lake City、Utah、美国、84106
- Utah Cancer Specialists
-
-
Washington
-
Tacoma、Washington、美国、98405
- MultiCare Regional Cancer Center - Tacoma
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国、53226
- Froedtert Hospital/Medical College of Wisconsin
-
-
-
-
-
Belfast、英国、BT9 7AB
- Belfast Health and Social Care Trust
-
Harlow、英国、CM20 1QX
- The Princess Alexandra Hospital
-
London、英国、SE1 9RT
- Guys and St Thomas NHS Foundation Trust
-
Manchester、英国、M20 4BX
- The Christie NHS Foundation Trust
-
Metropolitan Borough of Wirral、英国、CH63 4JY
- Clatterbridge Hospital
-
Nottingham、英国、NG5 1PB
- Nottingham University Hospitals NHS Trust
-
Wolverhampton、英国、WV10 0QP
- The Royal Wolverhampton NHS Trust
-
-
-
-
A Coruña
-
A Coruña、A Coruña、西班牙、15009
- Hospital Teresa Herrera C.H.U.A.
-
-
Barcelona
-
Badalona、Barcelona、西班牙、08916
- Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
-
Barcelona、Barcelona、西班牙、08035
- Hospital Universitari Vall d'Hebron
-
L'Hospitalet de Llobregat、Barcelona、西班牙、08908
- Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
-
-
Cantabria
-
Santander、Cantabria、西班牙、39008
- Hospital Universitario Marqués de Valdecilla
-
-
Córdoba
-
Córdoba、Córdoba、西班牙、14004
- Hospital Universitario Reina Sofía
-
-
Gran Canaria
-
Las Palmas de Gran Canaria、Gran Canaria、西班牙、35016
- Complejo Hospitalario Materno-Insular de Gran Canaria
-
-
Lugo
-
Lugo、Lugo、西班牙、27003
- Hospital Universitario Lucus Augusti
-
-
Madrid
-
Madrid、Madrid、西班牙、28041
- Hospital Universitario 12 de Octubre
-
Madrid、Madrid、西班牙、28007
- Hospital General Universitario Gregorio Marañón
-
Madrid、Madrid、西班牙、28050
- Hospital Universitario HM Sanchinarro
-
Madrid、Madrid、西班牙、28006
- Hospital Universitario La Paz
-
Madrid、Madrid、西班牙、28033
- MD Anderson Cancer Center
-
Madrid、Madrid、西班牙、28027
- Clínica Universidad de Navarra
-
Madrid、Madrid、西班牙、28034
- Hospital Universitario Ramón y Cajal
-
Madrid、Madrid、西班牙、28040
- Hospital Clínico San Carlos
-
Madrid、Madrid、西班牙、28040
- Hospital Universitario Fundación Jimenez Díaz
-
-
Málaga
-
Málaga、Málaga、西班牙、29010
- Hospital Regional Universitario Málaga Hospital Civil
-
-
Navarre
-
Pamplona、Navarre、西班牙、31008
- Clínica Universidad de Navarra
-
-
Pontevedra
-
Vigo、Pontevedra、西班牙、36312
- Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
-
-
Sevilla
-
Seville、Sevilla、西班牙、41013
- Hospital Universitario Virgen del Rocío
-
-
Valencia
-
Valencia、Valencia、西班牙、46026
- Hospital Universitari i Politècnic La Fe
-
-
Valladolid
-
Valladolid、Valladolid、西班牙、47003
- Hospital Clínico Universitario de Valladolid
-
-
Zaragoza
-
Zaragoza、Zaragoza、西班牙、50009
- Hospital Clínico Universitario Lozano Bleza
-
-
-
-
-
Cheongju-si、韩国、28644
- Chungbuk National University Hospital
-
Gyeonggi-do、韩国、13496
- CHA Bundang Medical Center, CHA University
-
Gyeonggi-do、韩国、16247
- The Catholic University of Korea, St.Vincents Hospital
-
Incheon、韩国、21565
- Gachon University Gil Medical Center
-
Incheon、韩国、22332
- Inha University Hospital
-
Seoul、韩国、05505
- Asan Medical Center
-
Seoul、韩国、03181
- Kangbuk Samsung Hospital
-
Seoul、韩国、06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul、韩国、07061
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
-
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)
-
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
-
Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
-
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).
-
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.
-
Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified.
-
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:
-
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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
其他名称：
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
其他名称：
|
|
实验性的：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
其他名称：
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
其他名称：
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 |
|
有源比较器：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 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free survival by IRC (Independent Review Committee)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
赞助
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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