Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
1
Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations
Key facts
- Sponsor
- Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Apr 2025 → 18 Jul 2025
- Decision date (initial)
- 2025-03-27
- 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 (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
- Sponsor organisation
- Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
- Address
- No. 9 Dongjin Road, Economic And Technical Development Zone Economic And Technical Development Zone
- City
- Lianyungang
- Postcode
- 222069
- Country
- China
Scientific contact point
- Organisation
- Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
- Contact name
- Shaonan Fan
Public contact point
- Organisation
- Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
- Contact name
- Shaonan Fan
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 3 | 1 |
| Rest of world
Serbia, Bosnia and Herzegovina, Moldova, Republic of
|
— | 17 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-04-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-06 | Bulgaria | Acceptable 2025-03-24
|
2025-03-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-26 | Bulgaria | Acceptable 2025-08-13
|
2025-08-14 |