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ACTIVE NOT RECRUITING
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

Last Updated

2026-03-09

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

Clinical Research Chile SpA

Valdivia, Los Ríos Region, Chile

James Lind Centro de Investigación del Cáncer

Temuco, Región de la Araucanía, 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

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

Naples, 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

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, Fukuoka, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Ohara HealthCare Foundation Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Osaka Habikino Medical Center

Habikino, Osaka, 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

II Klinika Chorob Pluc i Gruzlicy

Bialystok, Poland

Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K

Gdynia, Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii

Lodz, 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

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

Timișoara, Romania

Chungbuk National University Hospital

Cheongju-si, South Korea

CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea

The Catholic University of Korea, St.Vincents Hospital

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Inha University Hospital

Incheon, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, South Korea

Hospital Teresa Herrera C.H.U.A.

A Coruña, A Coruña, Spain

Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, 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

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Complejo Hospitalario Materno-Insular de Gran Canaria

Las Palmas de Gran Canaria, Gran Canaria, Spain

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Clínica Universidad de Navarra

Madrid, Madrid, Spain

MD Anderson Cancer Center

Madrid, Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario Fundación Jimenez Díaz

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Madrid, Spain

Hospital Regional Universitario Málaga Hospital Civil

Málaga, Málaga, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral

Vigo, Pontevedra, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

Hospital Clínico Universitario Lozano Bleza

Zaragoza, 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

Changhua Christian Hospital

Chang-hua, Chang Hua, Taiwan

Buddhist Dalin Tzu Chi Hospital

Dalin, Chiayi, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

National Taiwan University Cancer Center

Taipei, Taiwan

Medicalpark Seyhan Hospital

Seyhan, Adana, Turkey (Türkiye)

Liv Hospital Ankara

Çankaya, Ankara, Turkey (Türkiye)

Bagcilar Medipol Mega University Hospital

Bağcılar, Istanbul, Turkey (Türkiye)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Kadıköy, Istanbul, Turkey (Türkiye)

Kocaeli University Hospital

İzmit, Kocaeli, Turkey (Türkiye)

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

Clatterbridge Hospital

Metropolitan Borough of Wirral, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom