Clinical trial • Oncology

STX-721/PFL-721 for Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer

Clinical trial of STX-721/PFL-721 for Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer. 123 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer

Key dates

Initial CTIS Submission Date
10-10-2023
First CTIS Authorization Date
19-02-2024

Trial design

Clinical trial across 11 sites in Netherlands, Spain, Germany and others.

Target Sample Size
123

Recruitment

Planned Sample Size
123
Recruitment Window Months
39

Geography

Total Number Of Sites
11
Total Number Of Participants
128

Netherlands

Earliest CTIS Part Ii Submission Date
08-02-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
656
Number Of Sites
1
Number Of Participants
13

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Principal Investigator Name
Gerrina Ruiter
Principal Investigator Email
CPM-CRU@nki.nl
Contact Person Name
Gerrina Ruiter
Contact Person Email
CPM-CRU@nki.nl

Spain

Earliest CTIS Part Ii Submission Date
16-01-2024
Latest Decision Or Authorization Date
31-10-2025
Processing Time Days
654
Number Of Sites
4
Number Of Participants
46

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Enriqueta Felip
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Principal Investigator Name
Pilar Garrido
Principal Investigator Email
pilargarridol@gmail.com
Contact Person Name
Pilar Garrido
Contact Person Email
pilargarridol@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncologia Medica
Principal Investigator Name
Amparo Sanchez Gastaldo
Principal Investigator Email
asanchezgastaldo@gmail.com
Contact Person Name
Amparo Sanchez Gastaldo
Contact Person Email
asanchezgastaldo@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncologia Medica
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
manuelcobodols@yahoo.es
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es

Germany

Earliest CTIS Part Ii Submission Date
03-01-2024
Latest Decision Or Authorization Date
31-10-2025
Processing Time Days
667
Number Of Sites
2
Number Of Participants
23

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Onkologie und Hämatologie
Principal Investigator Name
Damian Rieke
Principal Investigator Email
studien-imt@charite.de
Contact Person Name
Damian Rieke
Contact Person Email
studien-imt@charite.de
Site Name
Technische Universitaet Dresden
Department Name
Nationales Centrum für Tumorerkrankungen Dresden
Principal Investigator Name
Martin Wermke
Principal Investigator Email
martin.wermke@uniklinikum-dresden.de
Contact Person Name
Martin Wermke

France

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
659
Number Of Sites
4
Number Of Participants
46

Sites

Site Name
Institut Curie
Department Name
Département Oncologie Médicale
Principal Investigator Name
Pauline DU RUSQUEC
Principal Investigator Email
pauline.durusquec@pierre-fabre.com
Contact Person Name
Pauline DU RUSQUEC
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Oncopole Claudius Regaud IUCT-O
Principal Investigator Name
Julien Mazieres
Principal Investigator Email
mazieres.j@chu-toulouse.fr
Contact Person Name
Julien Mazieres
Contact Person Email
mazieres.j@chu-toulouse.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Site René Gauducheau
Principal Investigator Name
Sandrine HIRET
Principal Investigator Email
sandrine.hiret@ico.unicancer.fr
Contact Person Name
Sandrine HIRET
Site Name
Institut Gustave Roussy
Department Name
Drug Development Department
Principal Investigator Name
Anas Gazzah
Principal Investigator Email
anas.gazzah@gustaveroussy.fr
Contact Person Name
Anas Gazzah
Contact Person Email
anas.gazzah@gustaveroussy.fr

Sponsor

Primary sponsor

Full Name
Pierre Fabre Medicament
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
STX-721/PFL-721

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