Clinical trial • Phase III • Oncology
GSK5764227 for Small cell lung cancer|Extensive-stage small cell lung cancer
Phase III trial of GSK5764227 for Small cell lung cancer|Extensive-stage small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Small cell lung cancer|Extensive-stage small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- ADC|Small molecule
Key dates
- Initial CTIS Submission Date
- 03-06-2025
- First CTIS Authorization Date
- 29-09-2025
Trial design
Randomised, open-label, topotecan (topotecane accord 1 mg/ml, solution à diluer pour perfusion); intravenous infusion; dose unit mg/m2 with max daily amount specified as 1.5 mg/m2 (schedule not specified in the provided data).-controlled Phase III trial in Germany, Portugal, Sweden and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Topotecan (TOPOTECANE ACCORD 1 mg/ml, solution à diluer pour perfusion); intravenous infusion; dose unit mg/m2 with max daily amount specified as 1.5 mg/m2 (schedule not specified in the provided data).
- Target Sample Size
- 139
Eligibility
Recruits 139 No vulnerable populations selected (isVulnerablePopulationSelected=false). Informed consent documentation is provided in multiple country/language versions; ICFs available for pregnant participants and pregnant partners and for genetic research; there is a document titled "L1_ICF_holders of parental authorit" indicating parental authority considerations where applicable..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected=false). Informed consent documentation is provided in multiple country/language versions; ICFs available for pregnant participants and pregnant partners and for genetic research; there is a document titled "L1_ICF_holders of parental authorit" indicating parental authority considerations where applicable.
Inclusion criteria
- {"criterion_text":"- \"Has histologically or cytologically confirmed Extensive stage-small cell lung cancer (ES-SCLC). \"\n- Has received prior therapy with only one prior platinum-based systemic therapy, given for at least 2 cycles in combination with a Programmed death receptor 1 or programmed death ligand 1 [PD-(L)1] inhibitor,\n- \"Has at least 1 non-brain target lesion (TL) per RECIST 1.1, as determined by the investigator \"\n- \"Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before the first dose. \"\n- Has adequate organ function. Screening specimens must be collected at least 3-5 days prior to pre-dose specimens, and pre-dose specimens must be collected within 24 hours prior to first dose."}
Exclusion criteria
- {"criterion_text":"- \"Prior use of or current use of treatments targeting B7 homolog 3 protein (B7-H3). \"\n- Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor\n- Pathological diagnosis of complex SCLC (such as mixed SCLC and NSCLC) or transformed SCLC (NSCLC to SCLC).\n- Any evidence of current ILD or pneumonitis or a prior history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids\n- \"Any of the following cardiac examination abnormalities •\tHas QTc >480 msec. •\tEvidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree AV block, second-degree AV block, PR interval >250 msec). •\tRisk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval. •\tLVEF fraction <50%. \"\n- Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to grade 1 with exceptions defined in the protocol.\n- History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins, DNA topoisomerase I inhibitor or regimens of Topotecan."}
Endpoints
Primary endpoints
- {"endpoint_text":"- \"ORR, defined as the percentage of participants with a confirmed CR or confirmed PR per RECIST 1.1 by BICR assessment \"","definition_or_measurement_approach":"Defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1 assessed by BICR (Blinded Independent Central Review)."}
- {"endpoint_text":"- OS, defined as the time from the date of randomization to the date of death by any cause","definition_or_measurement_approach":"Defined as time from randomization to death from any cause."}
Recruitment
- Planned Sample Size
- 139
- Recruitment Window Months
- 35
- Consent Approach
- Informed consent obtained from participants via L1 ICF documents. Multiple language versions of the main ICF and optional/targeted ICFs are available (examples: English, Portuguese, French, German, Spanish, Italian, Bulgarian, Hungarian, Romanian, Swedish, Polish). Specific ICFs exist for pregnant participants and pregnant partners, genetic research, continuation of treatment after progression, and other optional consents; documents named e.g. 'L1_ICF_Main', 'L1_ICF_Pregnant Participant', 'L1_ICF_Genetic Research', 'L1_ICF_Continuation of Treatment after PD' are provided. A document titled 'L1_ICF_holders of parental authorit' is present indicating procedures for parental authority where applicable.
Methods
- Country-specific recruitment materials (flyers, GP posters, tri-fold brochures) — multiple K2_Flyer / K2_GP Poster / K2_Tri-Fold Brochure documents listed for countries including PT, ES, HU, BG, RO, IT, SE and others (channels: printed/poster/flyer targeted at patients and primary care/GPs).
- Site-based recruitment using recruitment arrangements documents (K1_Recruitment and Informed Consent Procedure) — country-specific K1 documents available (e.g. Germany, Portugal, Bulgaria, Greece, Spain, Hungary, Romania, France, Italy, Finland, Sweden, Poland).
- Subject participation materials (Subject Participation Card, Thank You Card) provided at sites to participants.
- GP letters and other local site materials to inform healthcare providers (documents such as L2_GP Letter and other country-specific GP letters exist).
Geography
- Total Number Of Sites
- 77
- Total Number Of Participants
- 139
Germany
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 168
- Number Of Sites
- 15
- Number Of Participants
- 23
Sites
- Site Name
- Klinikum Nuernberg
- Department Name
- Klinik fuer Innere Medizin III Pneumologie
- Contact Person Name
- Markus Horneber
- Contact Person Email
- Markus.Horneber@klinikum-nuernberg.de
- Site Name
- Luebecker Onkologische Schwerpunktpraxis
- Contact Person Name
- Jens Kisro
- Contact Person Email
- jens.kisro@t-online.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin II
- Contact Person Name
- Christian Schulz
- Contact Person Email
- christian.schulz@ukr.de
- Site Name
- Robert Bosch Krankenhaus GmbH
- Department Name
- Abteilung für Hämatologie, Onkologie und Palliativmedizin
- Contact Person Name
- Perihan Canoglu
- Contact Person Email
- perihan.canoglu@rbk.de
- Site Name
- Evangelische Krankenhausgemeinschaft Herne/Castrop-Rauxel gGmbH
- Department Name
- Thoraxzentrum Ruhrgebiet, Sektion Thorakale Onkologie
- Contact Person Name
- Daniel C. Christoph
- Contact Person Email
- d.christoph@evk-herne.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik V
- Contact Person Name
- Diego Kauffmann-Guerrero
- Contact Person Email
- Diego.KauffmannGuerrero@med.uni-muenchen.de
- Site Name
- Franziskus Hospital Harderberg
- Department Name
- Klinik fuer Thoraxonkologie
- Contact Person Name
- Petra Hoffknecht
- Contact Person Email
- petra.hoffknecht@nsk.de
- Site Name
- Vincentius-Diakonissen-Kliniken gAG
- Department Name
- Klinik für Hämatologie, Onkologie, Immunologie und Palliativmedizin
- Contact Person Name
- Christian Meyer zum Bueschenfelde
- Contact Person Email
- christian.mzb@vincentius-ka.de
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Innere Medizin IV
- Contact Person Name
- Stefan Hammerschmidt
- Contact Person Email
- s.hammerschmidt@skc.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- II. Medizinische Klinik
- Contact Person Name
- Björn Hackanson
- Contact Person Email
- bjoern.hackanson@uk-augsburg.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Personalisierte Onkologie
- Contact Person Name
- Maike Collienne
- Contact Person Email
- maike.collienne@umm.de
- Site Name
- SLK-Kliniken Heilbronn GmbH
- Department Name
- Klinik für Thorakale Onkologie und Palliativmedizin
- Contact Person Name
- Jonas Kuon
- Contact Person Email
- jonas.kuon@slk-kliniken.de
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- Klinik für Kardiologie, Angiologie und Pneumologie
- Contact Person Name
- Martin Faehling
- Contact Person Email
- m.faehling@klinikum-esslingen.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Thoraxonkologie
- Contact Person Name
- Johannes Schnorbach
- Contact Person Email
- johannes.schnorbach@med.uni-heidelberg.de
- Site Name
- LungenClinic Grosshansdorf GmbH
- Contact Person Name
- Martin Reck
- Contact Person Email
- m.reck@lungenclinic.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 11-08-2025
- Latest Decision Or Authorization Date
- 20-01-2026
- Processing Time Days
- 162
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Pulmonology
- Contact Person Name
- Pedro Brito
- Contact Person Email
- pedroulisses@ulsaave.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
- Department Name
- Oncology
- Contact Person Name
- Sara Póvoa
- Contact Person Email
- 3957@ipocoimbra.min-saude.pt
- Site Name
- Champalimaud Clinical Centre
- Department Name
- Pulmology
- Contact Person Name
- Patrícia Garrido
- Contact Person Email
- patricia.garrido@fundacaochampalimaud.pt
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Pulmonology
- Contact Person Name
- Miguel Lopes
- Contact Person Email
- jmglps@gmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 144
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Patientområde Huvud och hals, lung och hudcancer Tema Cancer
- Contact Person Name
- Hannah Björn Andtback
- Contact Person Email
- firstname.lastname@regionstockholm.se
Hungary
- Earliest CTIS Part Ii Submission Date
- 30-07-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 173
- Number Of Sites
- 9
- Number Of Participants
- 13
Sites
- Site Name
- Matrai Gyogyintezet
- Department Name
- Pulmonology
- Contact Person Name
- Istvan Albert
- Contact Person Email
- albert.magy@gmail.com
- Site Name
- Matrai Gyogyintezet
- Department Name
- Pulmonology
- Contact Person Name
- László Urbán
- Contact Person Email
- drurban.laszlo@magy.eu
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Oncoradiology Centre
- Contact Person Name
- Zsuzsanna Kelemen
- Contact Person Email
- zsuzsanna.kelemen@gmail.com
- Site Name
- Reformatus Pulmonologiai Centrum
- Department Name
- Department VI. (Felnőtt aktív tüdőgyógyászat)
- Contact Person Name
- Gabriella Galffy
- Contact Person Email
- ggalffy@hotmail.com
- Site Name
- University Of Debrecen
- Department Name
- Pulmonology Clinic
- Contact Person Name
- Ildikó Horváth
- Contact Person Email
- horvath.ildiko@med.unideb.hu
- Site Name
- Orszagos Koranyi Pulmonologiai Intezet
- Department Name
- XIV. Pulmonology Department
- Contact Person Name
- Gabriella Temesi
- Contact Person Email
- temesi@koranyi.hu
- Site Name
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
- Department Name
- Pulmonology Department
- Contact Person Name
- Zsolt Pápai-Székely
- Contact Person Email
- zsoltpapai@yahoo.com
- Site Name
- Farkasgyepui Tudogyogyintezet
- Department Name
- I. Pulmonology
- Contact Person Name
- Zsolt Király
- Contact Person Email
- dr.kiraly.zsolt@gmail.com
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz (duplicate entry?)
- Department Name
- Oncoradiology Centre
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 16-09-2025
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 127
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Complex Oncology Center Ruse EOOD
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Nikolay Nikolaev
- Contact Person Email
- nikolay.evgeniev@gmail.com
- Site Name
- Military Medical Academy
- Department Name
- Clinic of medical oncology
- Contact Person Name
- Zhasmina Mihaylova
- Contact Person Email
- zhasmina.mihaylova@gmail.com
- Site Name
- Multiprofessional Hospital For Active Treatment Park Hospital Ltd.
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Vladimir Kanarev
- Contact Person Email
- kanarevi@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Yordan Ignatov
- Contact Person Email
- yordanignatov@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Serdicamed EOOD
- Department Name
- Second Department of Medical Oncology
- Contact Person Name
- Krassimir Koynov
- Contact Person Email
- kdkoynov@yahoo.co.uk
Greece
- Earliest CTIS Part Ii Submission Date
- 19-06-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 214
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- Oncology Department, International Oncology Center
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
- Site Name
- Athens Medical Center S.A.
- Department Name
- 4th Department of Medical Oncology and Clinical Trials Unit, International Oncology Center
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Propaedeutic Dept. of Internal Medicine, Oncology Unit, Research Unit
- Contact Person Name
- Amanda Psyrri
- Contact Person Email
- psyrri237@yahoo.com
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4th Department of Medical Oncology and Clinical Trials Unit
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Department of Medical Oncology, Clinical Trials office
- Contact Person Name
- Sofia Agelaki
- Contact Person Email
- agelaki@uoc.gr
- Site Name
- St. Savvas’ Hospital General Anti-Cancer and Oncological Hospital of Athens
- Department Name
- 2nd Department of Medical Oncology
- Contact Person Name
- Anastasios Grivas
- Contact Person Email
- tssgrvs@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 16-07-2025
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 190
- Number Of Sites
- 12
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Contact Person Name
- Edurne Arriola Aperribay
- Contact Person Email
- earriola@psmar.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Contact Person Name
- María Eugenia Olmedo García
- Contact Person Email
- mariaeugenia.olmedo@salud.madrid.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Luis Paz Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Noemi Reguart Aransay
- Contact Person Email
- nreguart@recerca.clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Pedro Filipe Simoes da Rocha
- Contact Person Email
- pedrorocha@vhio.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology
- Contact Person Name
- Javier de Castro Carpeño
- Contact Person Email
- javier.decastro@salud.madrid.org
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncology
- Contact Person Name
- Delvys Rodríguez Abreu
- Contact Person Email
- drodabr@gobiernodecanarias.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Miguel Ángel Mosteiro Lamas
- Contact Person Email
- contactfortrialsICOLH@iconcologia.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Contact Person Name
- Rosa Álvarez Álvarez
- Contact Person Email
- ralvareza@salud.madrid.org
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology
- Contact Person Name
- Marta López-Brea Piqueras
- Contact Person Email
- martafrancisca.lopezbrea@scsalud.es
- Site Name
- Hospital Universitario 12 De Octubre (duplicate?)
- Department Name
- Oncology
- Site Name
- Hospital Del Mar (duplicate?)
- Department Name
- Oncology
Ireland
- Earliest CTIS Part Ii Submission Date
- 25-08-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 151
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Beaumont Hospital
- Department Name
- Cancer Clinical Trials & Research Unit
- Contact Person Name
- Jarushka Naidoo
- Contact Person Email
- jarushkanaidoo@beaumont.ie
Poland
- Earliest CTIS Part Ii Submission Date
- 19-06-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 221
- Number Of Sites
- 9
- Number Of Participants
- 15
Sites
- Site Name
- Centrum Pulmonologii I Torakochirurgii W Bystrej
- Department Name
- Oddział Pulmunologiczno-Onkologiczny z Chemioterapią
- Contact Person Name
- Beata Kania-Zembaczyńska
- Contact Person Email
- oddzial.chemioterapii@szpitalbystra.pl
- Site Name
- Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
- Contact Person Name
- Katarzyna Stencel
- Contact Person Email
- kstencel@wcpit.org
- Site Name
- Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
- Department Name
- Siedleckie Centrum Onkologii; Oddział Onkologii Klinicznej i Radioterapii
- Contact Person Name
- Lubomir Bodnar
- Contact Person Email
- bbk@szpital.siedlce.pl
- Site Name
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
- Department Name
- Oddział III Chorób Płuc z Pododdziałem Onkologicznym
- Contact Person Name
- Aleksandra Szczęsna
- Contact Person Email
- ola_szczesna@outlook.com
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Ośrodek Chemioterapii Dziennej
- Contact Person Name
- Tomasz Kucharczyk
- Contact Person Email
- tomaszkucharczyk73@wp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
- Department Name
- Klinika Onkologii Klinicznej z Pododdziałem Onkologii Ginekologicznej
- Contact Person Name
- Małgorzata Drzymała
- Contact Person Email
- badaniakliniczne.pco@szpital.rzeszow.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Onkologii
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- ewakalinka@wp.pl
- Site Name
- Wielkopolskie Centrum Pulmonologii I Torakochirurgii (duplicate?)
- Site Name
- Other Polish participating site
Romania
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 151
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Institutul Regional De Oncologie Iasi
- Department Name
- Medical Oncology
- Contact Person Name
- Teodora Alexa-Stratulat
- Contact Person Email
- teodora.alexa-stratulat@umfiasi.ro
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Medical Oncology
- Contact Person Name
- Cristina Ligia Cebotaru
- Contact Person Email
- cristinacebotaru@yahoo.com
- Site Name
- Oncomed S.R.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Elvira Daniela Sirbu
- Contact Person Email
- daniela.sirbu@oncohelp.ro
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Oncolab S.R.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Cristian Lungulescu
- Contact Person Email
- cristilungulescu@yahoo.com
- Site Name
- Radiotherapy Center Cluj S.R.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Andrei Ungureanu
- Contact Person Email
- andrei.ungureanu@amethyst-radiotherapy.com
France
- Earliest CTIS Part Ii Submission Date
- 19-06-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 214
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Département de Médecine Oncologique
- Contact Person Name
- Pernelle LAVAUD
- Contact Person Email
- Pernelle.lavaud@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hopital Pontchaillou, Service de Pneumologie
- Contact Person Name
- Charles RICORDEL
- Contact Person Email
- charles.ricordel@chu-rennes.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Département d'Oncologie Médicale
- Contact Person Name
- Sandrine HIRET
- Contact Person Email
- sandrine.hiret@ico.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Service de Pneumologie et Physiologie
- Contact Person Name
- Denis MORO-SIBILOT
- Contact Person Email
- DMoro-Sibilot@chu-grenoble.fr
- Site Name
- Hopital Ambroise Pare
- Department Name
- Service Pneumologie et Oncologie Thoracique
- Contact Person Name
- Etienne GIROUX-LEPRIEUR
- Contact Person Email
- etienne.glroux-leprleur@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 160
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Senese
- Department Name
- U.O.C. Immunoterapia Oncologica
- Contact Person Name
- Michele Maio
- Contact Person Email
- maio@unisi.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- S.C.D.U. Oncologia Medica
- Contact Person Name
- Francesco Passiglia
- Contact Person Email
- francesco.passiglia@unito.it
- Site Name
- Cliniche Gavazzeni S.p.A.
- Department Name
- U.O. Oncologia Medica
- Contact Person Name
- Chiara Matilde Catania
- Contact Person Email
- chiara.catania@gavazzeni.it
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Nord Ovest
- Department Name
- U.O.C. Oncologia Medica
- Contact Person Name
- Giacomo Allegrini
- Contact Person Email
- giacomo.allegrini@uslnordovest.toscana.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Oncologia Toracica
- Contact Person Name
- Filippo de Marinis
- Contact Person Email
- filippo.demarinis@ieo.it
Finland
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 144
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Pohjois-Pohjanmaan hyvinvointialue
- Department Name
- Department of Oncology
- Contact Person Name
- Jussi Koivunen
- Contact Person Email
- etunimi.sukunimi@pohde.fi
- Site Name
- Vaasa Central Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Ravichandra Ravi
- Contact Person Email
- etunimi.sukunimi@ovph.fi
- Site Name
- Pohjois-Savon hyvinvointialue
- Department Name
- Oncology
- Contact Person Name
- Okko Kääriäinen
- Contact Person Email
- etunimi.sukunimi@pshyvinvointialue.fi
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Sermes CRO
- Responsibilities
- Patient fee reimbursement
- Name
- PPD Global Limited
Third parties
- {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"Patient fee reimbursement","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Rugani Hospital S.r.l.","duties_or_roles":"Imaging","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Poland","full_name":"Clinops Tomasz Lusawa","duties_or_roles":"Renting equipment/medical devices to GSK for clinical sites","organisation_type":"Industry"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term storage","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term storage","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Travel Concierge Service and Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"Reimbursement of patient fees and compensation. Payment of biological exams performed outside the sites.","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Spain","full_name":"C & M Trial Support S.L.","duties_or_roles":"Managment of biological samples","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Site Staff Engagement Platform","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"ePRO Licensing","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Trial Form Support S.L.","duties_or_roles":"Data Entry and Study Coordination support","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"Patient reimburesment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Primera Analytical Solutions Corp.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging, BICR and RANO-BM","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi","duties_or_roles":"Licensing of epros","organisation_type":"Patient organisation/association"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"Medicine product destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"Patient fee reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Greece","full_name":"Affidea Piraeus Biopathological","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Cental Laboratory logistics and supplies","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Patient Reported Outcomes","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- GSK5764227
- Active Substance
- GSK5764227
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Maximum Dose
- 8 mg/kg
- Investigational Product Name
- TOPOTECANE ACCORD (Topotecan)
- Active Substance
- Topotecan
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Marketing authorised (product details list marketing authorisation number and authorisation country FR)
- Maximum Dose
- 1.5 mg/m2
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