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
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
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
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
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxonkologie
Contact Person Name
Johannes Schnorbach
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
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
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

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
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
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
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
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
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
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
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

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
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
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

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
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

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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