Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
40
Countries
1
Sites
1
Non-Small Cell Lung Cancer
Key facts
- Sponsor
- Transgene
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-10-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10029519 | Non-small cell lung cancer stage III | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Transgene
- Sponsor organisation
- Transgene
- Address
- Parc D Innovation, 400 Boulevard Gonthier D Andernach, Cs 80166 Illkirch Graffenstaden, Illkirch Graffenstaden 400 Boulevard Gonthier D Andernach Cs 80166 Illkirch Graffenstaden
- City
- Illkirch Cedex
- Postcode
- 67405
- Country
- France
Scientific contact point
- Organisation
- Transgene
- Contact name
- Transgene medical affairs
Public contact point
- Organisation
- Transgene
- Contact name
- Transgene medical affairs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 20 | 1 |
| Rest of world
United Kingdom
|
— | 20 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-28 | France | Acceptable 2024-10-03
|
2024-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-22 | France | Acceptable 2025-03-24
|
2025-03-28 |