Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
60
Countries
2
Sites
2
Non-small cell lung cancer
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 May 2015 → ongoing
- Decision date (initial)
- 2024-04-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-510824-38-00
- EudraCT number
- 2014-005054-19
- ClinicalTrials.gov
- NCT02393625
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
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 9 | 1 |
| Spain | Ongoing, recruitment ended | 14 | 1 |
| Rest of world
United States, Singapore, Australia, Canada, United Kingdom, Hong Kong
|
— | 37 | — |
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 |
|---|---|---|---|---|---|
| Belgium | 2015-05-27 | 2015-05-27 | 2018-02-27 | ||
| Spain | 2015-07-07 | 2015-07-07 | 2018-02-27 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-29 | Spain | Acceptable 2024-04-09
|
2024-04-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-17 | Spain | Acceptable 2024-04-09
|
2025-02-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-02 | Spain | Acceptable 2025-09-08
|
2025-09-08 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-23 | Spain | Acceptable 2025-09-08
|
2025-09-23 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-24 | Spain | Acceptable 2025-09-08
|
2026-02-24 |