Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
121
Countries
2
Sites
5
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
- 27 Sep 2021 → 20 May 2026
- Decision date (initial)
- 2024-06-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508003-20-00
- EudraCT number
- 2020-006047-25
- ClinicalTrials.gov
- NCT04526691
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 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
- clinical trial office
Public contact point
- Organisation
- Daiichi Sankyo Inc.
- Contact name
- clinical trial office
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 5 | 1 |
| Spain | Ended | 32 | 4 |
| Rest of world
Taiwan, Japan, United States
|
— | 84 | — |
Investigational sites
Fondazione IRCCS San Gerardo Dei Tintori
Oncologia medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, 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 |
|---|---|---|---|---|---|
| Italy | 2021-09-29 | 2026-05-20 | 2022-03-31 | 2023-02-14 | |
| Spain | 2021-09-27 | 2026-04-28 | 2021-10-25 | 2023-06-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Italy | Acceptable 2024-06-21
|
2024-06-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-29 | Italy | Acceptable 2024-12-10
|
2024-12-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-13 | Italy | Acceptable 2025-08-13
|
2025-08-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-12 | Italy | Acceptable 2026-03-13
|
2026-03-17 |