Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
15
Countries
1
Sites
3
cell lung carcinoma
Key facts
- Sponsor
- Institut De Cancerologie De L Ouest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-05-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514057-30-00
- ClinicalTrials.gov
- NCT07007325
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
cell lung carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10059514 | Small cell lung cancer metastatic | 100000004864 |
| 21.1 | PT | 10041069 | Small cell lung cancer limited stage | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Cancerologie De L Ouest
- Sponsor organisation
- Institut De Cancerologie De L Ouest
- Address
- 15 Rue Andre Boquel
- City
- Angers
- Postcode
- 49100
- Country
- France
Scientific contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- LACOMBE Marie
Public contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- LACOMBE Marie
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 15 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Regional D'Angers
Nuclear Medicine, 4 Rue Larrey, 49100, Angers
Institut De Cancerologie De L Ouest
Nuclear Medicine, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut De Cancerologie De L Ouest
Nuclear Medicine, 15 Rue Andre Boquel, 49100, Angers
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-31 | France | Acceptable 2025-05-06
|
2025-05-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-15 | France | Acceptable 2025-10-30
|
2025-10-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-10 | France | Acceptable 2026-03-05
|
2026-03-12 |