再発小細胞肺癌患者におけるルルビネクテジンの単剤またはイリノテカンとトポテカンまたはイリノテカンとの併用の臨床試験（LAGOON）
再発小細胞肺癌患者におけるルルビネクテジン単剤またはルルビネクテジンとイリノテカンとの併用と治験責任医師の選択（トポテカンまたはイリノテカン）との無作為化多施設非盲検第III相試験（LAGOON試験）
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Arizona
-
Chandler、Arizona、アメリカ、85224
- Ironwood Cancer & Research Centers
-
-
Arkansas
-
Hot Springs、Arkansas、アメリカ、71913
- Genesis Cancer and Blood
-
-
Florida
-
Fort Myers、Florida、アメリカ、33901
- Florida Cancer Specialists - South
-
St. Petersburg、Florida、アメリカ、33705
- Florida Cancer Specialists - North
-
Tallahassee、Florida、アメリカ、32308
- Florida Cancer Specialists - Panhandle
-
West Palm Beach、Florida、アメリカ、33401
- Florida Cancer Specialists - East
-
-
Illinois
-
Joliet、Illinois、アメリカ、60435
- Duly Health and Care
-
-
Kentucky
-
Louisville、Kentucky、アメリカ、40202
- Norton Cancer Institue, Downtown
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02215
- Dana-Farber Cancer Institute
-
-
Nebraska
-
Grand Island、Nebraska、アメリカ、68803
- Oncology Hematology West, PC (Grand Island)
-
Omaha、Nebraska、アメリカ、68130
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
-
-
North Carolina
-
Pinehurst、North Carolina、アメリカ、28374
- FirstHealth Outpatient Cancer Center
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84106
- Utah Cancer Specialists
-
-
Washington
-
Tacoma、Washington、アメリカ、98405
- MultiCare Regional Cancer Center - Tacoma
-
-
Wisconsin
-
Milwaukee、Wisconsin、アメリカ、53226
- Froedtert Hospital/Medical College of Wisconsin
-
-
-
-
-
Belfast、イギリス、BT9 7AB
- Belfast Health and Social Care Trust
-
Harlow、イギリス、CM20 1QX
- The Princess Alexandra Hospital
-
London、イギリス、SE1 9RT
- Guys and St Thomas NHS Foundation Trust
-
Manchester、イギリス、M20 4BX
- The Christie NHS Foundation Trust
-
Metropolitan Borough of Wirral、イギリス、CH63 4JY
- Clatterbridge Hospital
-
Nottingham、イギリス、NG5 1PB
- Nottingham University Hospitals NHS Trust
-
Wolverhampton、イギリス、WV10 0QP
- The Royal Wolverhampton NHS Trust
-
-
-
-
-
Haifa、イスラエル、3109601
- Rambam Health Care Campu
-
Jerusalem、イスラエル、9103102
- Shaare Zedek Medical Center
-
Petah Tikva、イスラエル、49100
- Rabin Medical Center
-
Ramat Gan、イスラエル
- The Chaim Sheba Medical Center
-
Tel Aviv、イスラエル、6423906
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Alessandria、イタリア、15121
- A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
-
Ancona、イタリア、60126
- Azienda Ospedaliero Universitaria delle Marche
-
Aviano、イタリア、33081
- IRCCS Centro di Riferimento Oncologico
-
Bologna、イタリア、40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
-
Catania、イタリア、95125
- Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
-
Cuneo、イタリア、12100
- A.O. Santa Croce e Carle, Ospedale Carle
-
Florence、イタリア、50134
- AOU Careggi
-
Genova、イタリア、16149
- ASL 3 Genovese Oncologia Medica Villa Scassi
-
Milan、イタリア、20089
- IRCCS Istituto Clinico Humanitas - Cancer Center
-
Naples、イタリア、80138
- Universita degli Studi della Campania Luigi Vanvitelli
-
Novara、イタリア、28100
- Ospedale Maggiore di Novara
-
Orbassano、イタリア、10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
-
Padova、イタリア、35128
- Oncologia Medica II Istituto Oncologico Veneto IRCCS
-
Piacenza、イタリア、29121
- Azienda USL di Piacenza
-
Rionero in Vulture、イタリア、85028
- Irccs-Crob
-
Roma、イタリア、00128
- Fondazione Policlinico Universitario Campus Bio-Medico
-
Roma、イタリア、00128
- IFO Regina Elena
-
Sondrio、イタリア、23100
- ASST Valtellina e Alto Lario Ospedale di Sondrio
-
Varese、イタリア、21100
- ASST Sette Laghi
-
-
-
-
-
Frenchs Forest、オーストラリア、NSW 2086
- Northern Beaches Hospital
-
Gosford、オーストラリア、2250
- Gosford Hospital GH - Central Coast Cancer Centre
-
Heidelberg、オーストラリア、VIC 3084
- Austin Hospital- Medical Oncology Unit
-
Murdoch、オーストラリア、WA 6150
- St John of God Murdoch Hospital
-
Wollongong、オーストラリア、NSW 2500
- Cancer Care Wollongong
-
-
New South Wales
-
Camperdown、New South Wales、オーストラリア、2050
- The Chris Obrien Lifehouse
-
-
Victoria
-
Ballarat Central、Victoria、オーストラリア、3350
- BRICC - Ballarat Health Services
-
Box Hill、Victoria、オーストラリア、3128
- Box Hill Hospital Eastern Health Clinical School
-
-
-
-
-
Salzburg、オーストリア、A-5020
- University Hospital Salzburg
-
Vienna、オーストリア、A-1090
- Medizinische Universitaet Wien
-
-
-
-
-
Montreal、カナダ、H4A 3J1
- McGill University Health Centre (MUHC)
-
Toronto、カナダ、ON M5G 2C1
- University Health Network - Princess Margaret Hospital
-
-
Ontario
-
Hamilton、Ontario、カナダ、L8V 5C2
- Hamilton Health Sciences -Juravinski Cancer Centre
-
Newmarket、Ontario、カナダ、L3Y 2P9
- Southlake Regional Health Centre
-
-
Quebec
-
Laval、Quebec、カナダ、H7M 3L9
- Hôpital de la Cité-de-la- Santé
-
Longueuil、Quebec、カナダ、J4V 2H1
- CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne
-
-
-
-
-
Batumi、グルジア、6000
- High Technology Hospital Medcenter
-
Tbilisi、グルジア、112
- Todua Clinic
-
Tbilisi、グルジア、114
- New Hospitals
-
Tbilisi、グルジア、179
- JSC Evex Hospitals "Caraps Medline"
-
Tbilisi、グルジア、186
- LTD Cancer Research Centre
-
Tbilisi、グルジア、156
- Institute Of Clinical Oncology
-
-
-
-
-
Basel、スイス、4031
- University Hospital Basel
-
Bellinzona、スイス、6500
- Istituto Oncologico della Svizzera Italiana
-
Frauenfeld、スイス、8501
- Spital Thurgau - Kantonspital Frauenfeld
-
Lausanne、スイス、1011
- Centre Hospitalier Universitaire Vaudois
-
Liestal、スイス、4410
- Kantonsspital Baselland
-
Münsterlingen、スイス、8596
- Spital Thurgau - Kantonsspital Muensterlingen
-
Villars-sur-Glâne、スイス、1752
- HFR Freiburg Kantonsspital
-
-
-
-
A Coruña
-
A Coruña、A Coruña、スペイン、15009
- Hospital Teresa Herrera C.H.U.A.
-
-
Barcelona
-
Badalona、Barcelona、スペイン、08916
- Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
-
Barcelona、Barcelona、スペイン、08035
- Hospital Universitari Vall d'Hebron
-
L'Hospitalet de Llobregat、Barcelona、スペイン、08908
- Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
-
-
Cantabria
-
Santander、Cantabria、スペイン、39008
- Hospital Universitario Marqués de Valdecilla
-
-
Córdoba
-
Córdoba、Córdoba、スペイン、14004
- Hospital Universitario Reina Sofía
-
-
Gran Canaria
-
Las Palmas de Gran Canaria、Gran Canaria、スペイン、35016
- Complejo Hospitalario Materno-Insular de Gran Canaria
-
-
Lugo
-
Lugo、Lugo、スペイン、27003
- Hospital Universitario Lucus Augusti
-
-
Madrid
-
Madrid、Madrid、スペイン、28041
- Hospital Universitario 12 de Octubre
-
Madrid、Madrid、スペイン、28007
- Hospital General Universitario Gregorio Marañón
-
Madrid、Madrid、スペイン、28050
- Hospital Universitario HM Sanchinarro
-
Madrid、Madrid、スペイン、28006
- Hospital Universitario La Paz
-
Madrid、Madrid、スペイン、28033
- MD Anderson Cancer Center
-
Madrid、Madrid、スペイン、28027
- Clínica Universidad de Navarra
-
Madrid、Madrid、スペイン、28034
- Hospital Universitario Ramón y Cajal
-
Madrid、Madrid、スペイン、28040
- Hospital Clínico San Carlos
-
Madrid、Madrid、スペイン、28040
- Hospital Universitario Fundación Jimenez Díaz
-
-
Málaga
-
Málaga、Málaga、スペイン、29010
- Hospital Regional Universitario Málaga Hospital Civil
-
-
Navarre
-
Pamplona、Navarre、スペイン、31008
- Clínica Universidad de Navarra
-
-
Pontevedra
-
Vigo、Pontevedra、スペイン、36312
- Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
-
-
Sevilla
-
Seville、Sevilla、スペイン、41013
- Hospital Universitario Virgen del Rocío
-
-
Valencia
-
Valencia、Valencia、スペイン、46026
- Hospital Universitari i Politècnic La Fe
-
-
Valladolid
-
Valladolid、Valladolid、スペイン、47003
- Hospital Clínico Universitario de Valladolid
-
-
Zaragoza
-
Zaragoza、Zaragoza、スペイン、50009
- Hospital Clínico Universitario Lozano Bleza
-
-
-
-
-
Santiago、チリ
- Hospital Clinico Universidad de Chile
-
Santiago、チリ
- Clinica Alemana de Santiago
-
Santiago、チリ
- Centro de Estudios Clínicos SAGA
-
Santiago、チリ
- Clínica Santa María
-
Santiago、チリ
- Fundación Arturo López Pérez
-
-
Araucania
-
Temuco、Araucania、チリ、4780000
- James Lind Centro de Investigación del Cáncer
-
-
Los Ríos Region
-
Valdivia、Los Ríos Region、チリ、5090000
- Clinical Research Chile SpA
-
-
-
-
-
Aalborg、デンマーク、9000
- Aalborg University Hospital
-
Næstved、デンマーク、4700
- Sjællands Universitetshospital
-
Sønderborg、デンマーク、6400
- Sønderborg Sygehus
-
Vejle、デンマーク、7100
- Vejle Hospital
-
-
-
-
Adana
-
Seyhan、Adana、トルコ（Türkiye）、01140
- Medicalpark Seyhan Hospital
-
-
Ankara
-
Çankaya、Ankara、トルコ（Türkiye）、06680
- Liv Hospital Ankara
-
-
Istanbul
-
Bağcılar、Istanbul、トルコ（Türkiye）、34214
- Bagcilar Medipol Mega University Hospital
-
Kadıköy、Istanbul、トルコ（Türkiye）、34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
-
Kocaeli
-
İzmit、Kocaeli、トルコ（Türkiye）、41380
- Kocaeli University Hospital
-
-
-
-
-
Bad Berka、ドイツ、99437
- Zentralklinik Bad Berka GmbH
-
Berlin、ドイツ、13125
- Evangelische Lungenklinik Berlin
-
Bremen、ドイツ、28325
- Klinikum Bremen Ost
-
Duisburg、ドイツ、74166
- Helios St. Johannes Klinikum
-
Esslingen am Neckar、ドイツ、73730
- Klinikum Esslingen GmbH
-
Freiburg im Breisgau、ドイツ、79106
- Universittsklinikum Freiburg
-
Gauting、ドイツ、82131
- Asklepios Fachklinik München-Gauting
-
Halle、ドイツ、06120
- Universitaetsklinikum Halle Saale
-
Halle、ドイツ、06120
- Krankenhaus Martha-Maria Halle gGmbH
-
Heidelberg、ドイツ、69126
- Thoraxclinic Heidelberg GmbH
-
Karlsruhe、ドイツ、76137
- Vincentius-Diakonissen-Kliniken gAG Karlsruhe
-
Kassel、ドイツ、34125
- Klinikum Kassel - Medizinische Klinik IV
-
Löwenstein、ドイツ、74245
- Klinik Loewenstein gGmbH
-
Mannheim、ドイツ、68167
- Universitaetsmedizin Mannheim
-
München、ドイツ、81925
- Staedtisches Klinikum München - Bogenhausen
-
Offenbach、ドイツ、63069
- Sana Klinikum Offenbach
-
-
Schleswig-Holstein
-
Großhansdorf、Schleswig-Holstein、ドイツ、22927
- LungenClinic Grosshansdorf
-
-
-
-
-
Debrecen、ハンガリー、4032
- Debreceni Egyetem - Klinikai Kozpont
-
Farkasgyepű、ハンガリー、8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
-
Kecskemét、ハンガリー、6000
- Bacs-Kiskun County Hospital
-
Szolnok、ハンガリー、5004
- Hetenyi G Korhaz, Onkologiai Kozpont
-
Törökbálint、ハンガリー、2045
- Pulmonology Hospital Torokbalint
-
-
-
-
-
Besançon、フランス、25030
- Hopital Jean Minjoz
-
Boulogne-Billancourt、フランス、92100
- AssAP-HP - Hopital Ambroise-Pare
-
Brest、フランス、29200
- Hopital Morvan CHU de Brest
-
Caen、フランス、14000
- Centre François Baclesse
-
Caen、フランス、14033
- CHU de Caen - Hopital Cote de Nacre
-
Créteil、フランス、94000
- Centre Hospitalier Intercommunal de Creteil (CHIC)
-
Limoges、フランス、87000
- Centre Hospitalier Universitaire CHU De Limoges
-
Nantes、フランス、Cedex 01 44093
- CHU de Nantes
-
Paris、フランス、75018
- Bichat-Claude Bernard Hospital
-
Reims、フランス、51092
- CHU Reims - Hpital Maison Blanche
-
Strasbourg、フランス、67091
- Hopital Civil / Nouvel Hopital Civil
-
Suresnes、フランス、92150
- Hospital Foch
-
Villejuif、フランス、94805
- Gustave Roussy
-
-
-
-
-
Barretos、ブラジル、SP 14784-400
- Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
-
Ijuí、ブラジル、98700-00
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
-
Rio de Janeiro、ブラジル、20231-050
- Instituto Nacional de Cancer - Ministrio da Sade
-
-
Paraná
-
Curitiba、Paraná、ブラジル、82305-100
- Oncocentro-Centro de Oncologia do Parana
-
-
Porto Alegre
-
Porto Alegre、Porto Alegre、ブラジル、90050-170
- Irmandade daSanta Casa de Misericordia de Porto Alegre
-
Porto Alegre、Porto Alegre、ブラジル、90610-000
- Hospital Sao Lucas da PUCRS
-
Santa Cecília、Porto Alegre、ブラジル、RS 90035-903
- UPCO - Hospital de Clinicas de Porto Alegre
-
-
Salvador
-
Ondina、Salvador、ブラジル、BA 40170-110
- Nucleo de Oncologia da Bahia - NOB
-
-
-
-
-
Plovdiv、ブルガリア、4000
- Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
-
Sofia、ブルガリア、1303
- Specialized hospital for active treatment of oncological diseases
-
Sofia、ブルガリア、1632
- Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
-
-
Panagyurishte
-
Panagyurishte、Panagyurishte、ブルガリア、4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
-
-
-
-
-
Brasschaat、ベルギー、2930
- Algemeen Ziekenhuis AZ Klina - Borstkliniek
-
Charleroi、ベルギー、6000
- Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
-
Liège、ベルギー、4000
- CHR de la Citadelle
-
Liège、ベルギー、4000
- Centre Hospitalier Chretien CHC - MontLegia
-
Liège、ベルギー、4000
- CHU Liege
-
Mechelen、ベルギー、2800
- Az Sint Maarten Mechelen
-
Mons、ベルギー、7000
- Centre Hospitalier Universitaire (CHU) Ambroise Pare
-
-
Antwerp
-
Edegem、Antwerp、ベルギー、2650
- Antwerp University Hospital
-
-
-
-
-
Bialystok、ポーランド、15-569
- II Klinika Chorob Pluc i Gruzlicy
-
Gdynia、ポーランド、81-519
- Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
-
Lodz、ポーランド、93-513
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii
-
Lublin、ポーランド、20-093
- Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
-
Prabuty、ポーランド、82-550
- Szpital Specjalistyczny w Prabutach Sp. z o.o
-
Rzeszów、ポーランド、35-021
- Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
-
Tomaszów Mazowiecki、ポーランド、97-200
- Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
-
-
-
-
-
Baia Mare、ルーマニア、020945
- Sc Oncopremium Team Srl
-
Cluj-Napoca、ルーマニア、400641
- Medisprof srl
-
Craiova、ルーマニア、200385
- Oncolab SRL
-
Craiova、ルーマニア、200746
- Centrul de Oncologie Sfantu Nectarie
-
Ovidiu、ルーマニア、9005900
- Ovidius Clinical Hospital
-
Timișoara、ルーマニア、300166
- Oncocenter Oncologie clinica S.R.L
-
-
-
-
-
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
-
-
-
-
Aomori
-
Hirosaki、Aomori、日本、036-8563
- Hirosaki University Hospital
-
-
Fukuoka
-
Fukuoka、Fukuoka、日本、812-8582
- Kyushu University Hospital
-
-
Hyōgo
-
Kobe、Hyōgo、日本、650-0047
- Kobe City Medical Center General Hospital
-
-
Ishikawa-ken
-
Kanazawa、Ishikawa-ken、日本、920-8641
- Kanazawa University Hospital
-
-
Miyagi
-
Sendai、Miyagi、日本、980-0873
- Sendai Kousei Hospital
-
-
Okayama-ken
-
Kurashiki、Okayama-ken、日本、710-8602
- Ohara HealthCare Foundation Kurashiki Central Hospital
-
-
Osaka
-
Habikino、Osaka、日本
- Osaka Habikino Medical Center
-
Hirakata-shi、Osaka、日本、573-1191
- Kansai Medical University Hospital
-
Izumi、Osaka、日本、594-0073
- Izumi City General Hospital
-
Izumi、Osaka、日本、594-0073
- Kanagawa Cancer Center
-
Kishiwada、Osaka、日本、596-8501
- Kishiwada City Hospital
-
-
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
-
-
-
-
-
Cheongju-si、韓国、28644
- Chungbuk National University Hospital
-
Gyeonggi-do、韓国、13496
- CHA Bundang Medical Center, CHA University
-
Gyeonggi-do、韓国、16247
- The Catholic University of Korea, St.Vincents Hospital
-
Incheon、韓国、21565
- Gachon University Gil Medical Center
-
Incheon、韓国、22332
- Inha University Hospital
-
Seoul、韓国、05505
- Asan Medical Center
-
Seoul、韓国、03181
- Kangbuk Samsung Hospital
-
Seoul、韓国、06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul、韓国、07061
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Voluntary written informed consent of the patient obtained before any study-specific procedure
-
Age≥18 years
-
Histologically or cytologically confirmed diagnosis of SCLC.
-
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)
-
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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
他の名前：
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
他の名前：
|
|
実験的：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
他の名前：
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
他の名前：
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 |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free survival by IRC (Independent Review Committee)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- PM1183-C-008-21
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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