Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
54
Countries
5
Sites
15
Extensive-stage small cell lung carcinoma (ES-SCLC)
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Jan 2024 → ongoing
- Decision date (initial)
- 2023-12-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506008-20-00
- WHO UTN
- U1111-1291-5998
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Extensive-stage small cell lung carcinoma (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
Boehringer Ingelheim RCV GmbH & Co. KG
- Sponsor organisation
- Boehringer Ingelheim RCV GmbH & Co. KG
- Address
- Dr.-Boehringer-Gasse 5-11, Meidling Meidling
- City
- Vienna
- Postcode
- 1121
- Country
- Austria
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Locations
5 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 4 | 2 |
| France | Ongoing, recruitment ended | 12 | 4 |
| Germany | Authorised, recruiting | 3 | 1 |
| Poland | Ongoing, recruitment ended | 9 | 3 |
| Spain | Ongoing, recruitment ended | 12 | 5 |
| Rest of world
Switzerland, Japan, United States
|
— | 14 | — |
Investigational sites
Algemeen Ziekenhuis Groeninge
Longziekten, President Kennedylaan 4, 8500, Kortrijk
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut Bergonie
Early Phase Trials and Sarcoma Units, 229 Cours De L Argonne, 33000, Bordeaux
Hospices Civils De Lyon
Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Les Hopitaux Universitaires De Strasbourg
Centre d’Investigation Clinique-CIC, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Institut Gustave Roussy
Département d'Innovation Thérapeutique et d’Essais Précoces - DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Justus-Liebig-Universitaet Giessen
Medizinische Klinik IV Organonkologie, Gaffkystrasse 5, 35392, Giessen
Instytut Centrum Zdrowia Matki Polki
Department of Oncology, Ul. Rzgowska 281/289, 93-338, Lodz
Med Polonia Sp. z o.o.
NA, Obornicka 262, 60-693, Poznan
Uniwersyteckie Centrum Kliniczne
N/A, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Clinico Universitario De Valencia
Servicio de Hematología y Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Fundacion Instituto Valenciano De Oncologia
Servicio de Oncología Médica, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Virgen De La Macarena
Servicio de Oncología Médica, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Ramon Y Cajal
Servicio de Oncología Médica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
Unidad de Ensayos Clínicos Fase I, Calle De Isaac Peral 42 Oficinas 2a Planta Oficina 1, 28015, Madrid
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 | 2024-03-11 | 2024-03-29 | 2024-03-29 | 2024-03-29 | |
| France | 2024-02-22 | 2024-07-08 | 2025-07-31 | ||
| Germany | 2024-03-21 | ||||
| Poland | 2024-01-11 | 2024-02-14 | 2025-07-31 | ||
| Spain | 2024-03-06 | 2024-10-11 | 2025-07-31 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-38444
- Halt date
- 2024-07-31
- Member states concerned
- Germany
- Publication date
- 2024-08-01
- Reason
- Study management related
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-18 | Germany | Acceptable 2023-12-04
|
2023-12-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-22 | Acceptable | 2024-02-14 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-26 | Germany | Acceptable 2024-06-10
|
2024-06-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-02 | Germany | Acceptable 2025-01-27
|
2025-01-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-25 | Germany | Acceptable 2025-07-31
|
2025-08-01 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-03 | Germany | Acceptable 2026-04-20
|
2026-04-22 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-19 | Acceptable 2026-04-20
|
2026-05-19 |