Clinical trial • Phase III • Oncology
Tarlatamab for Extensive stage small cell lung cancer
Phase III trial of Tarlatamab for Extensive stage small cell lung cancer. 134 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Extensive stage small cell lung cancer
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 10-07-2024
- First CTIS Authorization Date
- 21-10-2024
Trial design
Phase III trial across 12 sites in Belgium, Germany, Spain and others.
- Target Sample Size
- 134
Eligibility
Recruits 134 Vulnerable population selected; no details on consent or assent handling available in the provided source..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling available in the provided source.
Recruitment
- Planned Sample Size
- 134
- Recruitment Window Months
- 63
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 86
Belgium
- Earliest CTIS Part Ii Submission Date
- 27-09-2024
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 549
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- UZ Leuven
- Department Name
- Respiratory Oncology
- Contact Person Name
- Els Wauters
- Contact Person Email
- els.wauters@uzleuven.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Longziekten
- Contact Person Name
- Karim Vermaelen
- Contact Person Email
- karim.vermaelen@Ugent.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Pneumologie
- Contact Person Name
- Astrid Paulus
- Contact Person Email
- apaulus@chuliege.be
Germany
- Earliest CTIS Part Ii Submission Date
- 07-10-2024
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 541
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Zentrum für Klinische Studien
- Contact Person Name
- Christian Schulz
- Contact Person Email
- christian.schulz@ukr.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Interdisziplinaeres Studienzentrum mit ECTU Zentrum für Innere Medizin
- Contact Person Name
- Hosrt-Dieter Hummel
- Contact Person Email
- hummel_h@ukw.de
Spain
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 548
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncología Médica
- Contact Person Name
- Maria Vanesa Gutierrez Calderon
- Contact Person Email
- vanesa_gutierrez78@hotmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncología
- Contact Person Name
- Oscar Jose Juan Vidal
- Contact Person Email
- Juan_osc@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- Contact Person Name
- Pedro Filipe Simões Da Rocha
- Contact Person Email
- pedrorocha@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
Poland
- Earliest CTIS Part Ii Submission Date
- 23-09-2024
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 557
- Number Of Sites
- 3
- Number Of Participants
- 13
Sites
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Oncology
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- grubiak.marta@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Contact Person Name
- Rafal Dziadziuszko
- Contact Person Email
- obkwf@uck.gda.pl
- Site Name
- Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
- Department Name
- Oncology
- Contact Person Name
- Kamil Kuc
- Contact Person Email
- kkuc@wszp.pl
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Tarlatamab
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
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