Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
90
Countries
3
Sites
10
relapsed/refractory extensive stage - small cell lung cancer (ES-SCLC)
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
- 15 Jan 2024 → ongoing
- Decision date (initial)
- 2024-03-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506007-26-00
- WHO UTN
- U1111-1293-4098
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
relapsed/refractory extensive stage - small cell lung cancer (ES-SCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041068 | Small cell lung cancer extensive stage | 100000004864 |
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 · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 20 | 3 |
| Germany | Ongoing, recruitment ended | 46 | 5 |
| Poland | Ongoing, recruitment ended | 5 | 2 |
| Rest of world
United Kingdom, United States
|
— | 19 | — |
Investigational sites
Institut Gustave Roussy
Département d'Innovation Thérapeutique et d’Essais Précoces - DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Les Hopitaux Universitaires De Strasbourg
Service de Pneumologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Institut Curie
Unité d'Investigation Clinique, 26 Rue D Ulm, 75005, Paris
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts
III. Medizinische Klinik, Hämatologie und Medizinische Onkologie, Building 704, Langenbeckstrasse 1, Mainz
Technische Universitat Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 1 - Bereich Pneumologie, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Wuerzburg AöR
Interdisziplinäres Studienzentrum mit ECTU, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Thoraxklinik Heidelberg gGmbH
Thoraxonkologie Heidelberg, Roentgenstrasse 1, Rohrbach, Heidelberg
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 | 2024-04-29 | 2024-07-02 | 2026-02-09 | ||
| Germany | 2024-01-15 | 2024-02-14 | 2026-02-09 | ||
| Poland | 2024-04-17 | 2024-06-10 | 2026-02-09 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-03-13
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with the version 6.4 of CTR Q&A / point 1.23, the sponsor is requested to submit a specific SM Part II only in France in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-16 | Germany | Acceptable 2023-12-04
|
2023-12-07 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-12-15 | Acceptable 2023-12-04
|
2024-03-25 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-20 | Acceptable | 2024-04-05 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-15 | Germany | Acceptable 2024-07-22
|
2024-07-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-09 | Germany | Acceptable 2024-12-09
|
2024-12-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-17 | Germany | Acceptable 2025-07-25
|
2025-07-28 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-04 | Germany | Acceptable 2026-04-07
|
2026-04-07 |