Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
160
Countries
5
Sites
17
Small Cell Lung Cancer
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
- 27 May 2026 → ongoing
- Decision date (initial)
- 2026-05-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522888-15-00
- WHO UTN
- U1111-1330-7464
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small Cell Lung Cancer
| 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
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 9 | 3 |
| France | Authorised, recruitment pending | 11 | 3 |
| Germany | Authorised, recruiting | 11 | 3 |
| Poland | Authorised, recruitment pending | 10 | 3 |
| Spain | Authorised, recruitment pending | 12 | 5 |
| Rest of world
Turkey, Australia, Korea, Republic of, United States, Switzerland
|
— | 107 | — |
Investigational sites
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Ziekenhuis Aan De Stroom
Medical Oncology, Oosterveldlaan 24, 2610, Antwerp
Universitair Ziekenhuis Gent
Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Hospices Civils De Lyon
Pulmonology Department, 59 Boulevard Pinel, 69500, Bron
Institut Gustave Roussy
Early Drug Development Department (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional De Marseille
Marseille Early Phase Oncology Clinical Trials Unit, 264 Rue Saint Pierre, 13005, Marseille
Charite Universitaetsmedizin Berlin KöR
Hematology, oncology and tumor immunology, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Wuerzburg AöR
Comprehensive Cancer Center Mainfranken, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Technische Universitaet Dresden
NCT Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Uniwersyteckie Centrum Kliniczne
Oncology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitari Vall D Hebron
Servicio de Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Victoria
Servicio de Oncologia, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitario 12 De Octubre
Servicio de Oncologia, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinico Universitario De Valencia
Servicio de Hematologia y Oncologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Ramon Y Cajal
Servicio de Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, 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 |
|---|---|---|---|---|---|
| Germany | 2026-05-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-28 | Belgium | Acceptable 2026-05-04
|
2026-05-05 |