Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
43
Countries
3
Sites
7
Small Cell Lung Carcinoma expressing DLL3
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
- 25 Aug 2023 → ongoing
- Decision date (initial)
- 2023-06-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small Cell Lung Carcinoma expressing DLL3
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10041058 | Small cell carcinoma of the lung | 10029104 |
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
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 15 | 2 |
| France | Ongoing, recruitment ended | 12 | 3 |
| Germany | Ongoing, recruitment ended | 10 | 2 |
| Rest of world
Japan
|
— | 6 | — |
Investigational sites
Universitair Ziekenhuis Gent
Vijverpark Container - Drug unit, 1st floor, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Department of Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut Claudius Regaud
Département d'Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Hospices Civils De Lyon
Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Centre Francois Baclesse
Service d'Oncologie Médicale, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Goethe University Frankfurt
Medizinische Klinik 2 - Hämatologie / Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Technische Universitat Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
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 |
|---|---|---|---|---|---|
| Belgium | 2023-08-25 | 2023-08-28 | 2025-04-29 | ||
| France | 2023-10-13 | 2023-11-09 | 2025-04-29 | ||
| Germany | 2023-09-28 | 2024-01-25 | 2025-04-29 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-14 | Germany | Acceptable with conditions 2023-06-06
|
2023-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-05 | Acceptable with conditions | 2023-08-21 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-08 | Germany | Acceptable with conditions | 2023-09-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-08-24 | Acceptable with conditions | 2023-09-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-11-22 | Germany | Acceptable with conditions 2024-03-11
|
2024-03-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-04-29 | Germany | Acceptable 2024-07-22
|
2024-07-23 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-05 | Germany | Acceptable 2025-03-31
|
2025-03-31 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-16 | Germany | Acceptable 2025-12-08
|
2025-12-09 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-19 | Germany | Acceptable 2025-12-08
|
2026-03-19 |