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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)
Sponsor: PharmaMar
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
705
Start Date
2022-07-22
Completion Date
2026-04-10
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Irinotecan
Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
Lurbinectedin
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
Irinotecan
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
Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk
Lurbinectedin
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
Locations (210)
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
St. 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, Paraná, Brazil
Irmandade daSanta Casa de Misericordia de Porto Alegre
Porto Alegre, Porto Alegre, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Porto Alegre, 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
Instituto Nacional de Cancer - Ministrio da Sade
Rio de Janeiro, Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
Panagyurishte, 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)
Montreal, 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 Region, Chile
Centro de Estudios Clínicos SAGA
Santiago, Chile
Clinica Alemana de Santiago
Santiago, Chile
Clínica Santa María
Santiago, Chile
Fundación Arturo López Pérez
Santiago, Chile
Hospital Clinico Universidad de Chile
Santiago, Chile
Aalborg University Hospital
Aalborg, Denmark
Sjællands Universitetshospital
Næstved, Denmark
Sønderborg Sygehus
Sønderborg, Denmark
Vejle Hospital
Vejle, Denmark
Hopital Jean Minjoz
Besançon, 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
Klinikum Bremen Ost
Bremen, Germany
Helios St. Johannes Klinikum
Duisburg, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany
Universittsklinikum Freiburg
Freiburg im Breisgau, Germany
Asklepios Fachklinik München-Gauting
Gauting, Germany
Krankenhaus Martha-Maria Halle gGmbH
Halle, 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