Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
86
Countries
1
Sites
2
Metastatic non small cell lung cancer (Phase I and expansion cohorts)
Key facts
- Sponsor
- Centr Georges Francois Leclerc
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 27 Nov 2024 → 17 Nov 2025
- Decision date (initial)
- 2024-11-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516717-20-00
- EudraCT number
- 2021-003848-25
- ClinicalTrials.gov
- NCT05259319
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic non small cell lung cancer (Phase I and expansion cohorts)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centr Georges Francois Leclerc
- Sponsor organisation
- Centr Georges Francois Leclerc
- Address
- 1 Rue Professeur Marion
- City
- Dijon
- Postcode
- 21000
- Country
- France
Scientific contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Pr François GHIRINGHELLI
Public contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Emilie REDERSTORFF
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 86 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-11-27 | 2024-11-27 | 2025-11-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-17 | France | Acceptable 2024-11-05
|
2024-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-15 | France | Acceptable 2026-01-20
|
2026-03-23 |