Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
13
Countries
1
Sites
1
non-small cell lung cancer or
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Nov 2021 → ongoing
- Decision date (initial)
- 2024-07-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514034-20-00
- EudraCT number
- 2021-001063-25
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
non-small cell lung cancer or
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 13 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting Amsterdam UMC
Radiology & Nuclear Medicine, De Boelelaan 1117, 1081 HV, Amsterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2021-11-16 | 2022-03-03 | 2026-01-07 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-15 | Netherlands | Acceptable with conditions 2024-07-29
|
2024-07-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-29 | Netherlands | Acceptable with conditions 2024-07-29
|
2024-10-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-14 | Netherlands | Acceptable with conditions 2024-07-29
|
2025-03-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-06 | Netherlands | Acceptable with conditions 2024-07-29
|
2025-08-06 |