Clinical trial • Phase III • Oncology
U3-1402 for Non-small cell lung cancer | Metastatic or unresectable non-small cell lung cancer
Phase III trial of U3-1402 for Non-small cell lung cancer | Metastatic or unresectable non-small cell lung cancer. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Metastatic or unresectable non-small cell lung cancer
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 25-07-2024
- First CTIS Authorization Date
- 15-08-2024
Trial design
None/Not specified-controlled Phase III trial across 9 sites in Netherlands, Spain.
- Comparator
- None/Not specified
- Target Sample Size
- 282
Eligibility
Recruits 282 Vulnerable population selected; no further details on consent or assent handling available in the record..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling available in the record.
Recruitment
- Planned Sample Size
- 282
- Recruitment Window Months
- 105
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 28
Netherlands
- Earliest CTIS Part Ii Submission Date
- 13-08-2024
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 609
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Pneumology
- Contact Person Name
- Gerrina Ruiter
- Contact Person Email
- g.ruiter@nki.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 13-08-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 612
- Number Of Sites
- 8
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- -
- Contact Person Name
- Valentina Boni
- Contact Person Email
- na@na.com
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- -
- Contact Person Name
- Fabricio Racca
- Contact Person Email
- na@na.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- -
- Contact Person Name
- Luis Gonzaga Paz-Ares Rodríguez
- Contact Person Email
- pazaresr@seom.org
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- -
- Contact Person Name
- Antonio Calles Blanco
- Contact Person Email
- na@na.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- -
- Contact Person Name
- Pilar Garrido Lopez
- Contact Person Email
- na@na.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- -
- Contact Person Name
- Anna Vilalta-Lacarra
- Contact Person Email
- avilaltal@unav.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- -
- Contact Person Name
- Ramón Yarza
- Contact Person Email
- Ramon.yarza@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- -
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- na@na.com
Sponsor
Primary sponsor
- Full Name
- Daiichi Sankyo Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- Listed as Public and Scientific contact (submissions@fortrea.com)
Investigational products
- Investigational Product Name
- U3-1402
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