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COMPLETED
NCT05153239
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Irinotecan

Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk

DRUG

Lurbinectedin

Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk

DRUG

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

DRUG

Topotecan

Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk

DRUG

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

And 110 more locations on ClinicalTrials.gov