Spots Global Cancer Trial Database for Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)
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Trial Identification
Brief Title: Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)
Official Title: A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)
Study ID: NCT05153239
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer & Research Centers, Chandler, Arizona, United States
Genesis Cancer and Blood, Hot Springs, Arkansas, United States
Florida Cancer Specialists - South, Fort Myers, Florida, United States
Florida Cancer Specialists - North, Saint Petersburg, Florida, United States
Florida Cancer Specialists - Panhandle, Tallahassee, Florida, United States
Florida Cancer Specialists - East, West Palm Beach, Florida, United States
Duly Health and Care, Joliet, Illinois, United States
Norton Cancer Institue, Downtown, Louisville, Kentucky, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Oncology Hematology West, PC (Grand Island), Grand Island, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
FirstHealth Outpatient Cancer Center, Pinehurst, North Carolina, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
MultiCare Regional Cancer Center - Tacoma, Tacoma, Washington, United States
Froedtert Hospital/Medical College of Wisconsin, Milwaukee, Wisconsin, United States
The Chris Obrien Lifehouse, Camperdown, New South Wales, Australia
BRICC - Ballarat Health Services, Ballarat Central, Victoria, Australia
Box Hill Hospital Eastern Health Clinical School, Box Hill, Victoria, Australia
Northern Beaches Hospital, Frenchs Forest, , Australia
Gosford Hospital GH - Central Coast Cancer Centre, Gosford, , Australia
Austin Hospital- Medical Oncology Unit, Heidelberg, , Australia
St John of God Murdoch Hospital, Murdoch, , Australia
Cancer Care Wollongong, Wollongong, , Australia
University Hospital Salzburg, Salzburg, , Austria
Medizinische Universitaet Wien, Vienna, , Austria
Antwerp University Hospital, Edegem, Antwerp, Belgium
Algemeen Ziekenhuis AZ Klina - Borstkliniek, Brasschaat, , Belgium
Grand Hopital de Charleroi GHdC - Hopital Saint Joseph, Charleroi, , Belgium
Centre Hospitalier Chretien CHC - MontLegia, Liège, , Belgium
CHR de la Citadelle, Liège, , Belgium
CHU Liege, Liège, , Belgium
Az Sint Maarten Mechelen, Mechelen, , Belgium
Centre Hospitalier Universitaire (CHU) Ambroise Pare, Mons, , Belgium
Oncocentro-Centro de Oncologia do Parana, Curitiba, Parana, Brazil
UPCO - Hospital de Clinicas de Porto Alegre, Santa Cecília, Porto Alegre, Brazil
Nucleo de Oncologia da Bahia - NOB, Ondina, Salvador, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor, Barretos, , Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda, Ijuí, , Brazil
Irmandade daSanta Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, , Brazil
Instituto Nacional de Cancer - Ministrio da Sade, Rio De Janeiro, , Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology, Panagyurishte, , Bulgaria
Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology, Plovdiv, , Bulgaria
Specialized hospital for active treatment of oncological diseases, Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology, Sofia, , Bulgaria
Hamilton Health Sciences -Juravinski Cancer Centre, Hamilton, Ontario, Canada
Southlake Regional Health Centre, Newmarket, Ontario, Canada
Hôpital de la Cité-de-la- Santé, Laval, Quebec, Canada
CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne, Longueuil, Quebec, Canada
McGill University Health Centre (MUHC), Montréal, , Canada
University Health Network - Princess Margaret Hospital, Toronto, , Canada
James Lind Centro de Investigación del Cáncer, Temuco, Araucania, Chile
Clinical Research Chile SpA, Valdivia, Los Ríos, Chile
Centro de Estudios Clínicos SAGA, Santiago de Chile, , Chile
Clinica Alemana de Santiago, Santiago de Chile, , Chile
Clínica Santa María, Santiago de Chile, , Chile
Fundación Arturo López Pérez, Santiago de Chile, , Chile
Hospital Clinico Universidad de Chile, Santiago de Chile, , Chile
Aalborg University Hospital, Aalborg, , Denmark
Sjællands Universitetshospital, Næstved, , Denmark
Sønderborg Sygehus, Sønderborg, , Denmark
Vejle Hospital, Vejle, , Denmark
Hopital Jean Minjoz, Besancon, , France
AssAP-HP - Hopital Ambroise-Pare, Boulogne-Billancourt, , France
Hopital Morvan CHU de Brest, Brest, , France
Centre François Baclesse, Caen, , France
CHU de Caen - Hopital Cote de Nacre, Caen, , France
Centre Hospitalier Intercommunal de Creteil (CHIC), Créteil, , France
Centre Hospitalier Universitaire CHU De Limoges, Limoges, , France
CHU de Nantes, Nantes, , France
Bichat-Claude Bernard Hospital, Paris, , France
CHU Reims - Hpital Maison Blanche, Reims, , France
Hopital Civil / Nouvel Hopital Civil, Strasbourg, , France
Hospital Foch, Suresnes, , France
Gustave Roussy, Villejuif, , France
High Technology Hospital Medcenter, Batumi, , Georgia
Todua Clinic, Tbilisi, , Georgia
New Hospitals, Tbilisi, , Georgia
Institute Of Clinical Oncology, Tbilisi, , Georgia
JSC Evex Hospitals "Caraps Medline", Tbilisi, , Georgia
LTD Cancer Research Centre, Tbilisi, , Georgia
LungenClinic Grosshansdorf, Großhansdorf, Schleswig Holstein, Germany
Zentralklinik Bad Berka GmbH, Bad Berka, , Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Charite - Universitaetsmedizin Berlin, Berlin, , Germany
Klinikum Bremen Ost, Bremen, , Germany
Helios St. Johannes Klinikum, Duisburg, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
Universittsklinikum Freiburg, Freiburg, , Germany
Asklepios Fachklinik München-Gauting, Gauting, , Germany
Krankenhaus Martha-Maria Halle gGmbH, Halle (saale), , Germany
Universitaetsklinikum Halle Saale, Halle, , Germany
Thoraxclinic Heidelberg GmbH, Heidelberg, , Germany
Vincentius-Diakonissen-Kliniken gAG Karlsruhe, Karlsruhe, , Germany
Klinikum Kassel - Medizinische Klinik IV, Kassel, , Germany
Klinik Loewenstein gGmbH, Löwenstein, , Germany
Universitaetsmedizin Mannheim, Mannheim, , Germany
Staedtisches Klinikum München - Bogenhausen, München, , Germany
Sana Klinikum Offenbach, Offenbach, , Germany
Debreceni Egyetem - Klinikai Kozpont, Debrecen, , Hungary
Veszprem Megyei Tudogyogyintezet Farkasgyepu, Farkasgyepű, , Hungary
Bacs-Kiskun County Hospital, Kecskemét, , Hungary
Hetenyi G Korhaz, Onkologiai Kozpont, Szolnok, , Hungary
Pulmonology Hospital Torokbalint, Törökbálint, , Hungary
Rambam Health Care Campu, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petah tikva, , Israel
The Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria, , Italy
Azienda Ospedaliero Universitaria delle Marche, Ancona, , Italy
IRCCS Centro di Riferimento Oncologico, Aviano, , Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica, Bologna, , Italy
Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco, Catania, , Italy
A.O. Santa Croce e Carle, Ospedale Carle, Cuneo, , Italy
AOU Careggi, Florence, , Italy
ASL 3 Genovese Oncologia Medica Villa Scassi, Genova, , Italy
IRCCS Istituto Clinico Humanitas - Cancer Center, Milan, , Italy
Universita degli Studi della Campania Luigi Vanvitelli, Napoli, , Italy
Ospedale Maggiore di Novara, Novara, , Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, , Italy
Oncologia Medica II Istituto Oncologico Veneto IRCCS, Padova, , Italy
Azienda USL di Piacenza, Piacenza, , Italy
Irccs-Crob, Rionero In Vulture, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico, Roma, , Italy
IFO Regina Elena, Roma, , Italy
Azienda Ospedaliera Univ. Senese Policlinico Le Scotte, Siena, , Italy
ASST Valtellina e Alto Lario Ospedale di Sondrio, Sondrio, , Italy
ASST Sette Laghi, Varese, , Italy
Hirosaki University Hospital, Hirosaki, Aomori, Japan
Kyushu University Hospital, Fukuoka-shi, Fukuoka, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Sendai Kousei Hospital, Sendai, Miyagi, Japan
Ohara HealthCare Foundation Kurashiki Central Hospital, Kurashiki, Okayama, Japan
Osaka Habikino Medical Center, Habikino, Osaka-Fu, Japan
Kansai Medical University Hospital, Hirakata-shi, Osaka, Japan
Izumi City General Hospital, Izumi, Osaka, Japan
Kanagawa Cancer Center, Izumi, Osaka, Japan
Kishiwada City Hospital, Kishiwada, Osaka, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō-Ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR, Koto-Ku, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine, Shinjuku-Ku, Tokyo, Japan
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
CHA Bundang Medical Center, CHA University, Gyeonggi-do, , Korea, Republic of
The Catholic University of Korea, St.Vincents Hospital, Gyeonggi-do, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, , Korea, Republic of
II Klinika Chorob Pluc i Gruzlicy, Białystok, , Poland
Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K, Gdynia, , Poland
Specjalistyczna Praktyka Lekarska Slawomir Mandziuka, Lublin, , Poland
Szpital Specjalistyczny w Prabutach Sp. z o.o, Prabuty, , Poland
Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p, Rzeszów, , Poland
Specjalistyczny Szpital Onkologiczny NU-MED sp. Z, Tomaszów Mazowiecki, , Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii, Łódź, , Poland
Sc Oncopremium Team Srl, Baia Mare, , Romania
Medisprof srl, Cluj-Napoca, , Romania
Oncolab SRL, Craiova, , Romania
Centrul de Oncologie Sfantu Nectarie, Craiova, , Romania
Ovidius Clinical Hospital, Ovidiu, , Romania
Oncocenter Oncologie clinica S.R.L, Timişoara, , Romania
Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals, L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Complejo Hospitalario Materno-Insular de Gran Canaria, Las Palmas De Gran Canaria, Gran Canaria, Spain
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral, Vigo, Pontevedra, Spain
Hospital Teresa Herrera C.H.U.A., A Coruña, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Clínica Universidad de Navarra, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario Fundación Jimenez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Regional Universitario Málaga Hospital Civil, Málaga, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Hospital Clínico Universitario de Valladolid, Valladolid, , Spain
Hospital Clínico Universitario Lozano Bleza, Zaragoza, , Spain
University Hospital Basel, Basel, , Switzerland
Istituto Oncologico della Svizzera Italiana, Bellinzona, , Switzerland
Spital Thurgau - Kantonspital Frauenfeld, Frauenfeld, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital Baselland, Liestal, , Switzerland
Spital Thurgau - Kantonsspital Muensterlingen, Münsterlingen, , Switzerland
HFR Freiburg Kantonsspital, Villars-sur-Glâne, , Switzerland
Buddhist Dalin Tzu Chi Hospital, Dalin, Chiayi, Taiwan
Changhua Christian Hospital, Chang Hua, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
National Taiwan University Cancer Center, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Medicalpark Seyhan Hospital, Seyhan, Adana, Turkey
Liv Hospital Ankara, Çankaya, Ankara, Turkey
Bagcilar Medipol Mega University Hospital, Bagcilar, Istambul, Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Kadıköy, Istambul, Turkey
Kocaeli University Hospital, İzmit, Kocaeli, Turkey
Belfast Health and Social Care Trust, Belfast, , United Kingdom
The Princess Alexandra Hospital, Harlow, , United Kingdom
Guys and St Thomas NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Clatterbridge Hospital, Wirral, , United Kingdom
The Royal Wolverhampton NHS Trust, Wolverhampton, , United Kingdom
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