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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

705

Participants

Timeline

Start Date

July 22, 2022

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Relapsed Small Cell Lung Cancer
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

Trial Locations (210)

106

National Taiwan University Cancer Center, Taipei

112

Todua Clinic, Tbilisi

114

New Hospitals, Tbilisi

156

Institute Of Clinical Oncology, Tbilisi

179

"JSC Evex Hospitals Caraps Medline", Tbilisi

186

LTD Cancer Research Centre, Tbilisi

500

Changhua Christian Hospital, Chang-hua

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1303

Specialized hospital for active treatment of oncological diseases, Sofia

1632

Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology, Sofia

1752

HFR Freiburg Kantonsspital, Villars-sur-Glâne

2045

Pulmonology Hospital Torokbalint, Törökbálint

2050

The Chris Obrien Lifehouse, Camperdown

2250

Gosford Hospital GH - Central Coast Cancer Centre, Gosford

2650

Antwerp University Hospital, Edegem

2800

Az Sint Maarten Mechelen, Mechelen

2930

Algemeen Ziekenhuis AZ Klina - Borstkliniek, Brasschaat

3128

Box Hill Hospital Eastern Health Clinical School, Box Hill

3350

BRICC - Ballarat Health Services, Ballarat Central

4000

Centre Hospitalier Chretien CHC - MontLegia, Liège

CHR de la Citadelle, Liège

CHU Liege, Liège

Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology, Plovdiv

4031

University Hospital Basel, Basel

4032

Debreceni Egyetem - Klinikai Kozpont, Debrecen

4410

Kantonsspital Baselland, Liestal

4500

Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology, Panagyurishte

4700

Sjællands Universitetshospital, Næstved

5004

Hetenyi G Korhaz, Onkologiai Kozpont, Szolnok

6000

Grand Hopital de Charleroi GHdC - Hopital Saint Joseph, Charleroi

High Technology Hospital Medcenter, Batumi

Bacs-Kiskun County Hospital, Kecskemét

6400

Sønderborg Sygehus, Sønderborg

6500

Istituto Oncologico della Svizzera Italiana, Bellinzona

7000

Centre Hospitalier Universitaire (CHU) Ambroise Pare, Mons

7100

Vejle Hospital, Vejle

8501

Spital Thurgau - Kantonspital Frauenfeld, Frauenfeld

8582

Veszprem Megyei Tudogyogyintezet Farkasgyepu, Farkasgyepű

8596

Spital Thurgau - Kantonsspital Muensterlingen, Münsterlingen

9000

Aalborg University Hospital, Aalborg

10043

Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano

12100

A.O. Santa Croce e Carle, Ospedale Carle, Cuneo

13125

Evangelische Lungenklinik Berlin, Berlin

13496

CHA Bundang Medical Center, CHA University, Gyeonggi-do

14000

Centre François Baclesse, Caen

14004

Hospital Universitario Reina Sofía, Córdoba

14033

CHU de Caen - Hopital Cote de Nacre, Caen

15009

Hospital Teresa Herrera C.H.U.A., A Coruña

15121

A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria

16149

ASL 3 Genovese Oncologia Medica Villa Scassi, Genova

16247

The Catholic University of Korea, St.Vincents Hospital, Gyeonggi-do

20089

IRCCS Istituto Clinico Humanitas - Cancer Center, Milan

21100

ASST Sette Laghi, Varese

21565

Gachon University Gil Medical Center, Incheon

22332

Inha University Hospital, Incheon

22927

LungenClinic Grosshansdorf, Großhansdorf

23100

ASST Valtellina e Alto Lario Ospedale di Sondrio, Sondrio

25030

Hopital Jean Minjoz, Besançon

27003

Hospital Universitario Lucus Augusti, Lugo

28006

Hospital Universitario La Paz, Madrid

28007

Hospital General Universitario Gregorio Marañón, Madrid

28027

Clínica Universidad de Navarra, Madrid

28033

MD Anderson Cancer Center, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clínico San Carlos, Madrid

Hospital Universitario Fundación Jimenez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

28100

Ospedale Maggiore di Novara, Novara

28325

Klinikum Bremen Ost, Bremen

28374

FirstHealth Outpatient Cancer Center, Pinehurst

28644

Chungbuk National University Hospital, Cheongju-si

29010

Hospital Regional Universitario Málaga Hospital Civil, Málaga

29121

Azienda USL di Piacenza, Piacenza

29200

Hopital Morvan CHU de Brest, Brest

31008

Clínica Universidad de Navarra, Pamplona

32308

Florida Cancer Specialists - Panhandle, Tallahassee

33081

IRCCS Centro di Riferimento Oncologico, Aviano

33401

Florida Cancer Specialists - East, West Palm Beach

33705

Florida Cancer Specialists - North, St. Petersburg

33901

Florida Cancer Specialists - South, Fort Myers

34125

Klinikum Kassel - Medizinische Klinik IV, Kassel

34214

Bagcilar Medipol Mega University Hospital, Bağcılar

34722

Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Kadıköy

35016

Complejo Hospitalario Materno-Insular de Gran Canaria, Las Palmas de Gran Canaria

35128

Oncologia Medica II Istituto Oncologico Veneto IRCCS, Padua

36312

Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral, Vigo

39008

Hospital Universitario Marqués de Valdecilla, Santander

40138

IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica, Bologna

40202

Norton Cancer Institue, Downtown, Louisville

41013

Hospital Universitario Virgen del Rocío, Seville

41380

Kocaeli University Hospital, İzmit

46026

Hospital Universitari i Politècnic La Fe, Valencia

47003

Hospital Clínico Universitario de Valladolid, Valladolid

49100

Rabin Medical Center, Petah Tikva

50009

Hospital Clínico Universitario Lozano Bleza, Zaragoza

50134

AOU Careggi, Florence

51092

CHU Reims - Hpital Maison Blanche, Reims

53226

Froedtert Hospital/Medical College of Wisconsin, Milwaukee

60126

Azienda Ospedaliero Universitaria delle Marche, Ancona

60435

Duly Health and Care, Joliet

63069

Sana Klinikum Offenbach, Offenbach

67091

Hopital Civil / Nouvel Hopital Civil, Strasbourg

68130

Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha

68167

Universitaetsmedizin Mannheim, Mannheim

68803

Oncology Hematology West, PC (Grand Island), Grand Island

69126

Thoraxclinic Heidelberg GmbH, Heidelberg

71913

Genesis Cancer and Blood, Hot Springs

73730

Klinikum Esslingen GmbH, Esslingen am Neckar

74166

Helios St. Johannes Klinikum, Duisburg

74245

Klinik Loewenstein gGmbH, Löwenstein

75018

Bichat-Claude Bernard Hospital, Paris

76137

Vincentius-Diakonissen-Kliniken gAG Karlsruhe, Karlsruhe

79106

Universittsklinikum Freiburg, Freiburg im Breisgau

80138

Universita degli Studi della Campania Luigi Vanvitelli, Napoli

81925

Staedtisches Klinikum München - Bogenhausen, München

82131

Asklepios Fachklinik München-Gauting, Gauting

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

84106

Utah Cancer Specialists, Salt Lake City

85028

Irccs-Crob, Rionero in Vulture

85224

Ironwood Cancer & Research Centers, Chandler

87000

Centre Hospitalier Universitaire CHU De Limoges, Limoges

92100

AssAP-HP - Hopital Ambroise-Pare, Boulogne-Billancourt

92150

Hospital Foch, Suresnes

94000

Centre Hospitalier Intercommunal de Creteil (CHIC), Créteil

94805

Gustave Roussy, Villejuif

95125

Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco, Catania

98405

MultiCare Regional Cancer Center - Tacoma, Tacoma

99437

Zentralklinik Bad Berka GmbH, Bad Berka

200385

Oncolab SRL, Craiova

200746

Centrul de Oncologie Sfantu Nectarie, Craiova

300166

Oncocenter Oncologie clinica S.R.L, Timișoara

400641

Medisprof srl, Cluj-Napoca

622401

Buddhist Dalin Tzu Chi Hospital, Dalin

3109601

Rambam Health Care Campu, Haifa

4780000

James Lind Centro de Investigación del Cáncer, Temuco

5090000

Clinical Research Chile SpA, Valdivia

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9005900

Ovidius Clinical Hospital, Ovidiu

9103102

Shaare Zedek Medical Center, Jerusalem

02215

Dana-Farber Cancer Institute, Boston

NSW 2086

Northern Beaches Hospital, Frenchs Forest

VIC 3084

Austin Hospital- Medical Oncology Unit, Heidelberg

WA 6150

St John of God Murdoch Hospital, Murdoch

NSW 2500

Cancer Care Wollongong, Wollongong

A-5020

University Hospital Salzburg, Salzburg

A-1090

Medizinische Universitaet Wien, Vienna

82305-100

Oncocentro-Centro de Oncologia do Parana, Curitiba

90050-170

Irmandade daSanta Casa de Misericordia de Porto Alegre, Porto Alegre

90610-000

Hospital Sao Lucas da PUCRS, Porto Alegre

RS 90035-903

UPCO - Hospital de Clinicas de Porto Alegre, Santa Cecília

BA 40170-110

Nucleo de Oncologia da Bahia - NOB, Ondina

SP 14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor, Barretos

98700-00

ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda, Ijuí

20231-050

Instituto Nacional de Cancer - Ministrio da Sade, Rio de Janeiro

L8V 5C2

Hamilton Health Sciences -Juravinski Cancer Centre, Hamilton

L3Y 2P9

Southlake Regional Health Centre, Newmarket

H7M 3L9

Hôpital de la Cité-de-la- Santé, Laval

J4V 2H1

CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne, Longueuil

H4A 3J1

McGill University Health Centre (MUHC), Montreal

ON M5G 2C1

University Health Network - Princess Margaret Hospital, Toronto

Unknown

Centro de Estudios Clínicos SAGA, Santiago

Clinica Alemana de Santiago, Santiago

Clínica Santa María, Santiago

Fundación Arturo López Pérez, Santiago

Hospital Clinico Universidad de Chile, Santiago

The Chaim Sheba Medical Center, Ramat Gan

Osaka Habikino Medical Center, Habikino

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō-Ku

Cedex 01 44093

CHU de Nantes, Nantes

06120

Krankenhaus Martha-Maria Halle gGmbH, Halle

Universitaetsklinikum Halle Saale, Halle

00128

Fondazione Policlinico Universitario Campus Bio-Medico, Roma

IFO Regina Elena, Roma

036-8563

Hirosaki University Hospital, Hirosaki

812-8582

Kyushu University Hospital, Fukuoka

650-0047

Kobe City Medical Center General Hospital, Kobe

920-8641

Kanazawa University Hospital, Kanazawa

980-0873

Sendai Kousei Hospital, Sendai

710-8602

Ohara HealthCare Foundation Kurashiki Central Hospital, Kurashiki

573-1191

Kansai Medical University Hospital, Hirakata-shi

594-0073

Izumi City General Hospital, Izumi

Kanagawa Cancer Center, Izumi

596-8501

Kishiwada City Hospital, Kishiwada

135-8550

The Cancer Institute Hospital Of JFCR, Koto-Ku

162-8655

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-Ku

15-569

II Klinika Chorob Pluc i Gruzlicy, Bialystok

81-519

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

93-513

Wojewódzkie Wielospecjalistyczne Centrum Onkologii, Lodz

20-093

Specjalistyczna Praktyka Lekarska Slawomir Mandziuka, Lublin

82-550

Szpital Specjalistyczny w Prabutach Sp. z o.o, Prabuty

35-021

Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p, Rzeszów

97-200

Specjalistyczny Szpital Onkologiczny NU-MED sp. Z, Tomaszów Mazowiecki

020945

Sc Oncopremium Team Srl, Baia Mare

03181

Kangbuk Samsung Hospital, Seoul

05505

Asan Medical Center, Seoul

06591

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

07061

Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul

08916

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

08035

Hospital Universitari Vall d'Hebron, Barcelona

08908

Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals, L'Hospitalet de Llobregat

01140

Medicalpark Seyhan Hospital, Seyhan

06680

Liv Hospital Ankara, Çankaya

BT9 7AB

Belfast Health and Social Care Trust, Belfast

CM20 1QX

The Princess Alexandra Hospital, Harlow

SE1 9RT

Guys and St Thomas NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

CH63 4JY

Clatterbridge Hospital, Metropolitan Borough of Wirral

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

WV10 0QP

The Royal Wolverhampton NHS Trust, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaMar

INDUSTRY

NCT05153239 - 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) | Biotech Hunter | Biotech Hunter