Clinical trial • Phase II • Oncology
DS-1062a for Non-small cell lung cancer
Phase II trial of DS-1062a for Non-small cell lung cancer. open-label, none/not specified-controlled. 100 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 08-08-2024
- First CTIS Authorization Date
- 20-09-2024
Trial design
open-label, none/not specified-controlled Phase II trial in France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 100
Eligibility
Recruits 100 Vulnerable population selected; no details provided on consent or assent in source..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent in source.
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 83
- Consent Approach
- No information on informed consent or assent provided.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 100
France
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 27-10-2025
- Processing Time Days
- 433
- Number Of Sites
- 9
- Number Of Participants
- 100
Sites
- Site Name
- Institut Bergonie
- Department Name
- Oncologie
- Contact Person Name
- Sophie COUSIN
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncologie
- Contact Person Name
- David Planchard
- Contact Person Email
- Planchard.david@gustaveroussy.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Oncologie
- Contact Person Name
- Sébastien Couraud
- Contact Person Email
- ebastien.couraud@chu-lyon.fr
- Site Name
- Hôpital Cochin
- Department Name
- Oncologie
- Contact Person Name
- marie wislez
- Contact Person Email
- marie.wislez@aphp.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Oncologie
- Contact Person Name
- Celine MASCAUX
- Contact Person Email
- celine.mascaux@chru-strasbourg.fr
- Site Name
- Hopital Tenon
- Department Name
- Oncologie
- Contact Person Name
- Jacques Cadranel
- Contact Person Email
- jacques.cadranel@aphp.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncologie
- Contact Person Name
- RADJ Gervais
- Contact Person Email
- r.gervais@baclesse.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncologie
- Contact Person Name
- MARGAUX Geier
- Contact Person Email
- margaux.geier@chu-brest.fr
- Site Name
- Centre Hospitalier Intercommunal de Créteil
- Department Name
- Oncologie
- Contact Person Name
- christos Chouaid
- Contact Person Email
- christos.chouaid@chicreteil.fr
Sponsor
Primary sponsor
- Full Name
- Institut Gustave Roussy
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- DS-1062a, an Anti-TROP-2-Antibody-Drug Conjugate (ADC)
- Active Substance
- DS-1062a
- Modality
- ADC
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