Clinical trial • Phase III • Oncology

gilteritinib for Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer

Phase III trial of gilteritinib for Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer. 28 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
04-09-2025
First CTIS Authorization Date
14-01-2026

Trial design

Phase III trial in France, Spain.

Target Sample Size
28

Eligibility

Recruits 28 Vulnerable population selected; no details on consent or assent provided..

Vulnerable Population
Vulnerable population selected; no details on consent or assent provided.

Recruitment

Planned Sample Size
28
Recruitment Window Months
47

Geography

Total Number Of Sites
7
Total Number Of Participants
12

France

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
90
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology Department
Principal Investigator Name
Audrey Rabeau
Principal Investigator Email
Rabeau.audrey@xn--iuctoncopole-j09f.fr
Contact Person Name
Audrey Rabeau
Site Name
Institut Gustave Roussy
Department Name
MEDICAL ONCOLOGY
Principal Investigator Name
Benjamin Besse
Principal Investigator Email
benjamin.besse@gustaveroussy.fr
Contact Person Name
Benjamin Besse
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical oncology
Principal Investigator Name
Judith Raimbourg
Principal Investigator Email
judith.raimbourg@ico.unicancer.fr
Contact Person Name
Judith Raimbourg

Spain

Earliest CTIS Part Ii Submission Date
17-11-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
63
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Principal Investigator Name
Santiago Ponce Aix
Principal Investigator Email
santiago.ponce@oncosur.org
Contact Person Name
Santiago Ponce Aix
Contact Person Email
santiago.ponce@oncosur.org
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Principal Investigator Name
Ramón Yarza Barrio
Principal Investigator Email
ramon.yarza@startmadrid.com
Contact Person Name
Ramón Yarza Barrio
Contact Person Email
ramon.yarza@startmadrid.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario Regional De Malaga
Department Name
Medical Oncology
Principal Investigator Name
Manuel Ángel Cobo Dols
Principal Investigator Email
manuelcobodols@yahoo.es
Contact Person Name
Manuel Ángel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es

Sponsor

Primary sponsor

Full Name
Astellas Pharma Global Development Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
gilteritinib
Active Substance
gilteritinib
Modality
Small molecule

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