Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
310
Countries
2
Sites
9
METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER
Key facts
- Sponsor
- Daiichi Sankyo Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 May 2020 → ongoing
- Decision date (initial)
- 2024-08-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511205-33-00
- EudraCT number
- 2017-000543-41
- ClinicalTrials.gov
- NCT03260491
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Daiichi Sankyo Inc.
- Sponsor organisation
- Daiichi Sankyo Inc.
- Address
- 211 Mount Airy Road
- City
- Basking Ridge
- Postcode
- 07920-2311
- Country
- United States
Scientific contact point
- Organisation
- Daiichi Sankyo Inc.
- Contact name
- Fortrea Inc.
Public contact point
- Organisation
- Daiichi Sankyo Inc.
- Contact name
- Fortrea Inc.
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 8 | 1 |
| Spain | Ongoing, recruitment ended | 20 | 8 |
| Rest of world
Japan, United States, Taiwan, Korea, Democratic People's Republic of
|
— | 282 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Pneumology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Ramon Y Cajal
-, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Clinica Universidad De Navarra
-, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
-, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
-, Calle Ona 10, 28050, Madrid
Hospital Universitario Quironsalud Madrid
-, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital General Universitario Gregorio Maranon
-, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Quironsalud Barcelona
-, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario 12 De Octubre
-, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| Netherlands | 2020-05-19 | 2020-07-07 | 2025-04-15 | ||
| Spain | 2020-05-18 | 2020-06-26 | 2025-12-01 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-25 | Netherlands | Acceptable with conditions 2024-08-15
|
2024-08-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Netherlands | Acceptable 2025-02-03
|
2025-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-18 | Acceptable | 2025-09-01 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-10 | Netherlands | Acceptable | 2025-09-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-21 | Netherlands | Acceptable 2026-04-14
|
2026-04-14 |