Clinical trial • Phase III • Oncology
Trastuzumab deruxtecan for Advanced breast cancer | Non-small cell lung cancer
Phase III trial of Trastuzumab deruxtecan for Advanced breast cancer | Non-small cell lung cancer. 76 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced breast cancer | Non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- ADC | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 03-10-2024
- First CTIS Authorization Date
- 24-10-2024
Eligibility
Recruits 76 Vulnerable population not selected; no consent/assent details provided..
- Vulnerable Population
- Vulnerable population not selected; no consent/assent details provided.
Recruitment
- Recruitment Window Months
- 74
- Consent Approach
- Informed consent process not provided in the record; no details on assent or language-specific documents.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 76
France
- Latest Decision Or Authorization Date
- 05-05-2026
- Number Of Sites
- 2
- Number Of Participants
- 45
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Departement d’oncologie medicale
- Contact Person Name
- Julien MAZIERES
- Contact Person Email
- mazieres.julien@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Centre d’Essais Précoces en Cancérologie de Marseille (CEPCM)
- Contact Person Name
- Marie Meurer
- Contact Person Email
- marie.meurer@ap-hm.fr
Spain
- Latest Decision Or Authorization Date
- 11-05-2026
- Number Of Sites
- 2
- Number Of Participants
- 31
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Medical Oncology
- Contact Person Name
- Maria Rosario Garcia Campelo
- Contact Person Email
- MA.Rosario.Garcia.Campelo@sergas.es
Sponsor
Primary sponsor
- Full Name
- Daiichi Sankyo Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Trastuzumab Deruxtecan
- Active Substance
- Trastuzumab deruxtecan
- Modality
- ADC
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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