Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
40
Countries
2
Sites
2
Non small cell lung cancer
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2026-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non small cell lung cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Evelien van Genugten
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Evelien van Genugten
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 20 | 1 |
| Netherlands | Authorised, recruitment pending | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitätsklinikum Tübingen
Medical Oncology & Dept. Medical Oncology and Pneumology, Ottfried-Müller-Str. 10, 72076, Tübingen
Radboud universitair medisch centrum Stichting
Pulmonology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-06 | Netherlands | Acceptable 2026-06-29
|
2026-06-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-06-30 | Netherlands | Acceptable 2026-06-29
|
2026-06-30 |