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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