Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
220
Countries
4
Sites
12
Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
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
- 22 Nov 2024 → ongoing
- Decision date (initial)
- 2024-10-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511838-12-00
- WHO UTN
- U1111-1308-2523
- ClinicalTrials.gov
- NCT06598306
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
| 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
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 24 | 3 |
| Germany | Ongoing, recruiting | 24 | 2 |
| Poland | Ongoing, recruiting | 13 | 3 |
| Spain | Ongoing, recruiting | 25 | 4 |
| Rest of world
Japan, Switzerland, Australia, United States, China, Turkey
|
— | 134 | — |
Investigational sites
Centre hospitalier universitaire de Liege
Pneumologie, Avenue De L'hopital 1, 4000, Liege
UZ Leuven
Respiratory Oncology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Longziekten, Corneel Heymanslaan 10, 9000, Gent
Universitaetsklinikum Wuerzburg AöR
Interdisziplinaeres Studienzentrum mit ECTU Zentrum für Innere Medizin, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Universitaetsklinikum Regensburg AöR
Zentrum für Klinische Studien, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oncology, Ul. Monte Cassino 18, 37-700, Przemysl
Instytut Centrum Zdrowia Matki Polki
Oncology, Ul. Rzgowska 281/289, 93-338, Lodz
Uniwersyteckie Centrum Kliniczne
N/A, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Universitari Vall D Hebron
Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Y Politecnico La Fe
Oncología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Regional De Malaga
Oncología Médica, Avenida De Carlos De Haya S/N, 29010, Malaga
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 | 2024-11-22 | 2025-01-02 | |||
| Germany | 2024-12-02 | 2025-01-09 | |||
| Poland | 2024-12-10 | 2024-12-27 | |||
| Spain | 2024-12-16 | 2024-12-31 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-10 | Belgium | Acceptable 2024-10-21
|
2024-10-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-20 | Belgium | Acceptable 2025-08-14
|
2025-08-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-10 | Belgium | Acceptable 2025-11-14
|
2025-11-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-19 | Belgium | Acceptable 2026-03-30
|
2026-03-30 |