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)
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)
1 other identifier
interventional
705
23 countries
202
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2022
Typical duration for phase_3
202 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 10, 2021
CompletedStudy Start
First participant enrolled
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedMarch 9, 2026
March 1, 2026
3.7 years
November 29, 2021
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival (OS) will be calculated from the date of randomization to the date of death or last contact (in this case, survival will be censored on that date).
From the date of randomization to the date of death or last contact, up to 39 months
Secondary Outcomes (13)
Progression-free survival by IRC (Independent Review Committee)
From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
Progression-free survival by IA (Investigator Assessment)
From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
Overall response rate by IRC
From the date of randomization to the date of death or last contact, up to 39 months
Overall response rate by IA
From the date of randomization to the date of death or last contact, up to 39 months
Overall survival rate at 12 months
At 12 months
- +8 more secondary outcomes
Study Arms (3)
Lurbinectedin
EXPERIMENTALPatients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle)
Lurbinectedin plus Irinotecan
EXPERIMENTALPatients will consecutively receive the following q3wk (every three weeks = one treatment cycle): * Irinotecan (Day 1 and Day 8) * Lurbinectedin (Day 1)
Control arm
ACTIVE COMPARATORBest Investigator's choice prior to randomization between: * Irinotecan on Day 1 q3wk * Topotecan on Days 1-5 q3wk
Interventions
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
Eligibility Criteria
You may qualify if:
- Voluntary written informed consent of the patient obtained before any study-specific procedure
- Age≥18 years
- Histologically or cytologically confirmed diagnosis of SCLC.
- One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
- Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days (independent of the immunotherapy maintenance, if applicable)
- Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment
- Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
- Adequate hematological, renal, metabolic and hepatic function:
- Hemoglobin ≥ 9.0 g/dL \[patients may have received prior red blood cell (RBC) transfusion, if clinically indicated\]; absolute neutrophil count (ANC) ≥ 2.0 x 10\^9/L, and platelet count ≥ 100 x 10\^9/L.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN.
- Albumin ≥ 3.0 g/dL.
- Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula).
- At least three weeks since last prior antineoplastic treatment and recovery to grade ≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, immune-related hypothyroidism, anemia, asthenia and alopecia, all grade ≤ 2) according to the National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE) v.5.
- Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified.
- +1 more criteria
You may not qualify if:
- Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
- Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
- Active or untreated CNS metastases and/or carcinomatous meningitis.
- Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization.
- Concomitant diseases/conditions:
- History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
- Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
- Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.
- Known Gilbert's disease.
- Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture. Presence of external drainages.
- Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related antiviral therapy within six months prior to the first dose of study drugs will also be excluded.
- Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease or pulmonary fibrosis.
- Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma and who has been continuously in remission since then will be permitted.
- Limitation of the patient's ability to comply with the treatment or to follow the protocol.
- Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmaMarlead
Study Sites (210)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
Genesis Cancer and Blood
Hot Springs, Arkansas, 71913, United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, 32308, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401, United States
Duly Health and Care
Joliet, Illinois, 60435, United States
Norton Cancer Institue, Downtown
Louisville, Kentucky, 40202, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Oncology Hematology West, PC (Grand Island)
Grand Island, Nebraska, 68803, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
MultiCare Regional Cancer Center - Tacoma
Tacoma, Washington, 98405, United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
The Chris Obrien Lifehouse
Camperdown, New South Wales, 2050, Australia
BRICC - Ballarat Health Services
Ballarat Central, Victoria, 3350, Australia
Box Hill Hospital Eastern Health Clinical School
Box Hill, Victoria, 3128, Australia
Northern Beaches Hospital
Frenchs Forest, NSW 2086, Australia
Gosford Hospital GH - Central Coast Cancer Centre
Gosford, 2250, Australia
Austin Hospital- Medical Oncology Unit
Heidelberg, VIC 3084, Australia
St John of God Murdoch Hospital
Murdoch, WA 6150, Australia
Cancer Care Wollongong
Wollongong, NSW 2500, Australia
University Hospital Salzburg
Salzburg, A-5020, Austria
Medizinische Universitaet Wien
Vienna, A-1090, Austria
Antwerp University Hospital
Edegem, Antwerp, 2650, Belgium
Algemeen Ziekenhuis AZ Klina - Borstkliniek
Brasschaat, 2930, Belgium
Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
Charleroi, 6000, Belgium
Centre Hospitalier Chretien CHC - MontLegia
Liège, 4000, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
CHU Liege
Liège, 4000, Belgium
Az Sint Maarten Mechelen
Mechelen, 2800, Belgium
Centre Hospitalier Universitaire (CHU) Ambroise Pare
Mons, 7000, Belgium
Oncocentro-Centro de Oncologia do Parana
Curitiba, Paraná, 82305-100, Brazil
Irmandade daSanta Casa de Misericordia de Porto Alegre
Porto Alegre, Porto Alegre, 90050-170, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Porto Alegre, 90610-000, Brazil
UPCO - Hospital de Clinicas de Porto Alegre
Santa Cecília, Porto Alegre, RS 90035-903, Brazil
Nucleo de Oncologia da Bahia - NOB
Ondina, Salvador, BA 40170-110, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
Barretos, SP 14784-400, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
Ijuí, 98700-00, Brazil
Instituto Nacional de Cancer - Ministrio da Sade
Rio de Janeiro, 20231-050, Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
Panagyurishte, Panagyurishte, 4500, Bulgaria
Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
Plovdiv, 4000, Bulgaria
Specialized hospital for active treatment of oncological diseases
Sofia, 1303, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
Sofia, 1632, Bulgaria
Hamilton Health Sciences -Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
Hôpital de la Cité-de-la- Santé
Laval, Quebec, H7M 3L9, Canada
CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne
Longueuil, Quebec, J4V 2H1, Canada
McGill University Health Centre (MUHC)
Montreal, H4A 3J1, Canada
University Health Network - Princess Margaret Hospital
Toronto, ON M5G 2C1, Canada
Clinical Research Chile SpA
Valdivia, Los Ríos Region, 5090000, Chile
James Lind Centro de Investigación del Cáncer
Temuco, Región de la Araucanía, 4780000, 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, 9000, Denmark
Sjællands Universitetshospital
Næstved, 4700, Denmark
Sønderborg Sygehus
Sønderborg, 6400, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Hopital Jean Minjoz
Besançon, 25030, France
AssAP-HP - Hopital Ambroise-Pare
Boulogne-Billancourt, 92100, France
Hopital Morvan CHU de Brest
Brest, 29200, France
Centre François Baclesse
Caen, 14000, France
CHU de Caen - Hopital Cote de Nacre
Caen, 14033, France
Centre Hospitalier Intercommunal de Creteil (CHIC)
Créteil, 94000, France
Centre Hospitalier Universitaire CHU De Limoges
Limoges, 87000, France
CHU de Nantes
Nantes, Cedex 01 44093, France
Bichat-Claude Bernard Hospital
Paris, 75018, France
CHU Reims - Hpital Maison Blanche
Reims, 51092, France
Hopital Civil / Nouvel Hopital Civil
Strasbourg, 67091, France
Hospital Foch
Suresnes, 92150, France
Gustave Roussy
Villejuif, 94805, France
High Technology Hospital Medcenter
Batumi, 6000, Georgia
Todua Clinic
Tbilisi, 112, Georgia
New Hospitals
Tbilisi, 114, Georgia
Institute Of Clinical Oncology
Tbilisi, 156, Georgia
JSC Evex Hospitals "Caraps Medline"
Tbilisi, 179, Georgia
LTD Cancer Research Centre
Tbilisi, 186, Georgia
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, 22927, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Klinikum Bremen Ost
Bremen, 28325, Germany
Helios St. Johannes Klinikum
Duisburg, 74166, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730, Germany
Universittsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Fachklinik München-Gauting
Gauting, 82131, Germany
Krankenhaus Martha-Maria Halle gGmbH
Halle, 06120, Germany
Universitaetsklinikum Halle Saale
Halle, 06120, Germany
Thoraxclinic Heidelberg GmbH
Heidelberg, 69126, Germany
Vincentius-Diakonissen-Kliniken gAG Karlsruhe
Karlsruhe, 76137, Germany
Klinikum Kassel - Medizinische Klinik IV
Kassel, 34125, Germany
Klinik Loewenstein gGmbH
Löwenstein, 74245, Germany
Universitaetsmedizin Mannheim
Mannheim, 68167, Germany
Staedtisches Klinikum München - Bogenhausen
München, 81925, Germany
Sana Klinikum Offenbach
Offenbach, 63069, Germany
Debreceni Egyetem - Klinikai Kozpont
Debrecen, 4032, Hungary
Veszprem Megyei Tudogyogyintezet Farkasgyepu
Farkasgyepű, 8582, Hungary
Bacs-Kiskun County Hospital
Kecskemét, 6000, Hungary
Hetenyi G Korhaz, Onkologiai Kozpont
Szolnok, 5004, Hungary
Pulmonology Hospital Torokbalint
Törökbálint, 2045, Hungary
Rambam Health Care Campu
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, 15121, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126, Italy
IRCCS Centro di Riferimento Oncologico
Aviano, 33081, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
Bologna, 40138, Italy
Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
Catania, 95125, Italy
A.O. Santa Croce e Carle, Ospedale Carle
Cuneo, 12100, Italy
AOU Careggi
Florence, 50134, Italy
ASL 3 Genovese Oncologia Medica Villa Scassi
Genova, 16149, Italy
IRCCS Istituto Clinico Humanitas - Cancer Center
Milan, 20089, Italy
Universita degli Studi della Campania Luigi Vanvitelli
Naples, 80138, Italy
Ospedale Maggiore di Novara
Novara, 28100, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
Oncologia Medica II Istituto Oncologico Veneto IRCCS
Padua, 35128, Italy
Azienda USL di Piacenza
Piacenza, 29121, Italy
Irccs-Crob
Rionero in Vulture, 85028, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
IFO Regina Elena
Roma, 00128, Italy
ASST Valtellina e Alto Lario Ospedale di Sondrio
Sondrio, 23100, Italy
ASST Sette Laghi
Varese, 21100, Italy
Hirosaki University Hospital
Hirosaki, Aomori, 036-8563, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
Ohara HealthCare Foundation Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602, Japan
Osaka Habikino Medical Center
Habikino, Osaka, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Izumi City General Hospital
Izumi, Osaka, 594-0073, Japan
Kanagawa Cancer Center
Izumi, Osaka, 594-0073, Japan
Kishiwada City Hospital
Kishiwada, Osaka, 596-8501, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, 135-8550, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, 162-8655, Japan
II Klinika Chorob Pluc i Gruzlicy
Bialystok, 15-569, Poland
Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
Gdynia, 81-519, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii
Lodz, 93-513, Poland
Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
Lublin, 20-093, Poland
Szpital Specjalistyczny w Prabutach Sp. z o.o
Prabuty, 82-550, Poland
Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
Rzeszów, 35-021, Poland
Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
Tomaszów Mazowiecki, 97-200, Poland
Sc Oncopremium Team Srl
Baia Mare, 020945, Romania
Medisprof srl
Cluj-Napoca, 400641, Romania
Oncolab SRL
Craiova, 200385, Romania
Centrul de Oncologie Sfantu Nectarie
Craiova, 200746, Romania
Ovidius Clinical Hospital
Ovidiu, 9005900, Romania
Oncocenter Oncologie clinica S.R.L
Timișoara, 300166, Romania
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
CHA Bundang Medical Center, CHA University
Gyeonggi-do, 13496, South Korea
The Catholic University of Korea, St.Vincents Hospital
Gyeonggi-do, 16247, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Asan Medical Center
Seoul, 05505, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
Hospital Teresa Herrera C.H.U.A.
A Coruña, A Coruña, 15009, Spain
Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004, Spain
Complejo Hospitalario Materno-Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007, Spain
Clínica Universidad de Navarra
Madrid, Madrid, 28027, Spain
MD Anderson Cancer Center
Madrid, Madrid, 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario Fundación Jimenez Díaz
Madrid, Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid, Madrid, 28050, Spain
Hospital Regional Universitario Málaga Hospital Civil
Málaga, Málaga, 29010, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
Vigo, Pontevedra, 36312, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003, Spain
Hospital Clínico Universitario Lozano Bleza
Zaragoza, Zaragoza, 50009, Spain
University Hospital Basel
Basel, 4031, Switzerland
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500, Switzerland
Spital Thurgau - Kantonspital Frauenfeld
Frauenfeld, 8501, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
Kantonsspital Baselland
Liestal, 4410, Switzerland
Spital Thurgau - Kantonsspital Muensterlingen
Münsterlingen, 8596, Switzerland
HFR Freiburg Kantonsspital
Villars-sur-Glâne, 1752, Switzerland
Changhua Christian Hospital
Chang-hua, Chang Hua, 500, Taiwan
Buddhist Dalin Tzu Chi Hospital
Dalin, Chiayi, 622401, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Kaohsiung, 83301, Taiwan
National Taiwan University Cancer Center
Taipei, 106, Taiwan
Medicalpark Seyhan Hospital
Seyhan, Adana, 01140, Turkey (Türkiye)
Liv Hospital Ankara
Çankaya, Ankara, 06680, Turkey (Türkiye)
Bagcilar Medipol Mega University Hospital
Bağcılar, Istanbul, 34214, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, Istanbul, 34722, Turkey (Türkiye)
Kocaeli University Hospital
İzmit, Kocaeli, 41380, Turkey (Türkiye)
Belfast Health and Social Care Trust
Belfast, BT9 7AB, United Kingdom
The Princess Alexandra Hospital
Harlow, CM20 1QX, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Clatterbridge Hospital
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 10, 2021
Study Start
July 22, 2022
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03