Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
184
Countries
6
Sites
15
Extensive Stage Small cell lung cancer (ES-SCLC)
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Aug 2022 → ongoing
- Decision date (initial)
- 2024-08-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511021-58-00
- EudraCT number
- 2021-005462-17
- WHO UTN
- U1111-1309-5174
- ClinicalTrials.gov
- NCT05361395
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
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
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
6 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 12 | 4 |
| France | Ongoing, recruitment ended | 14 | 3 |
| Germany | Ongoing, recruitment ended | 27 | 3 |
| Italy | Ongoing, recruitment ended | 1 | 1 |
| Netherlands | Ongoing, recruitment ended | 4 | 1 |
| Spain | Ongoing, recruitment ended | 22 | 3 |
| Rest of world
Australia, United States, Japan, Korea, Republic of, Switzerland, Israel, Taiwan, Canada
|
— | 104 | — |
Investigational sites
Antwerp University Hospital
Oncologie, Drie Eikenstraat 655, 2650, Edegem
Algemeen Ziekenhuis Delta
Pneumology, Deltalaan 1, 8800, Roeselare
Jessa Ziekenhuis
Respiratoire Oncologie, Stadsomvaart 11, 3500, Hasselt
Az Maria Middelares Gent
Pneumologie, Buitenring-Sint-Denijs 30, 9000, Gent
Institut Gustave Roussy
Departement d'Innovation Therapeutique et d'Essais Précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Nantes
Service Pneumologie, Institut du thorax, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Leon Berard
Service de Cancerologie Medicale, 28 Rue Laennec, 69008, Lyon
Technische Universitaet Dresden
Early Clinical Trial Unit - Universitaetskrebszentrum, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Medical Center - University Of Freiburg
Klinik für Tumorbiologie, Breisacher Str. 117, 79106, Freiburg
Universitaetsklinikum Essen AöR
Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
Fondazione IRCCS San Gerardo Dei Tintori
Unità Operativa Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Universitair Medisch Centrum Groningen
Pulmonary medicine, Hanzeplein 1, 9713 GZ, Groningen
Hospital Germans Trias I Pujol
Servicio de Oncologia, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario 12 De Octubre
Servicio de Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Vall D Hebron
Servicio de Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2022-09-30 | 2023-02-21 | 2024-08-28 | ||
| France | 2022-08-25 | 2022-09-21 | 2024-08-28 | ||
| Germany | 2022-08-09 | 2022-08-25 | 2024-08-28 | ||
| Italy | 2023-01-27 | 2023-05-23 | 2024-08-28 | ||
| Netherlands | 2022-12-01 | 2023-07-13 | 2024-08-28 | ||
| Spain | 2022-08-02 | 2023-01-10 | 2024-08-28 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-05 | Spain | Acceptable with conditions 2024-08-23
|
2024-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-21 | Spain | Acceptable 2025-01-30
|
2025-01-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-19 | Spain | Acceptable 2025-05-22
|
2025-05-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-23 | Acceptable 2025-05-22
|
2025-06-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-04 | Spain | Acceptable 2025-10-09
|
2025-10-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-28 | Spain | Acceptable 2026-02-09
|
2026-02-11 |