Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruitment ended
Participants planned
135
Countries
2
Sites
6
Non-small cell lung cancer
Key facts
- Sponsor
- Samsung Bioepis Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Feb 2024 → ongoing
- Decision date (initial)
- 2024-01-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-small cell lung cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Samsung Bioepis Co. Ltd.
- Sponsor organisation
- Samsung Bioepis Co. Ltd.
- Address
- 76 Songdogyoyuk Ro
- City
- Yeonsu
- Postcode
- 21987
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Samsung Bioepis Co. Ltd.
- Contact name
- Regulatory affairs
Public contact point
- Organisation
- Samsung Bioepis Co. Ltd.
- Contact name
- Regulatory affairs
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 23 | 2 |
| Spain | Ongoing, recruitment ended | 18 | 4 |
| Rest of world
Korea, Republic of, Turkey
|
— | 94 | — |
Investigational sites
Uniwersyteckie Centrum Kliniczne
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, ul. Reymonta 83/91, Poland, Otwock
Hospital Universitario Severo Ochoa
Oncology, Avenida Orellana S/n, 28911, Leganes
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 |
|---|---|---|---|---|---|
| Poland | 2024-02-28 | 2024-06-03 | 2025-10-15 | ||
| Spain | 2024-02-28 | 2024-04-17 | 2025-10-15 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-22 | Spain | Acceptable 2024-01-19
|
2024-01-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-18 | Spain | Acceptable 2024-04-30
|
2024-04-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-04 | Acceptable | 2024-08-12 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-05 | Spain | Acceptable | 2024-07-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-13 | Spain | Acceptable | 2024-09-13 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-19 | Spain | Acceptable 2024-10-29
|
2024-10-29 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-04 | Spain | Acceptable 2025-03-18
|
2025-03-24 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-12 | Spain | Acceptable 2025-07-21
|
2025-07-22 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-19 | Spain | Acceptable 2026-02-17
|
2026-02-19 |