Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
102
Countries
1
Sites
1
Patients with localy advanced or metastatic non squamous non small cell lung cancer with PDL1˂50%.
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] - Neoplasms [C04]
- Trial duration
- 24 Jul 2024 → ongoing
- Decision date (initial)
- 2024-03-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with localy advanced or metastatic non squamous non small cell lung cancer with PDL1˂50%.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
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
- Head of project
Public contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Head of project
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 102 | 1 |
| 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 | 2024-07-24 | 2024-07-25 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-03 | France | Acceptable 2024-03-04
|
2024-03-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-17 | France | Acceptable 2025-02-12
|
2025-03-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-26 | France | Acceptable 2025-06-20
|
2025-06-20 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-05 | France | Acceptable 2025-06-20
|
2025-12-05 |