Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
144
Countries
2
Sites
3
Patients with EGFR-mutant 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
- 20 Dec 2024 → ongoing
- Decision date (initial)
- 2024-07-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511757-21-00
- EudraCT number
- 2017-002496-25
- ClinicalTrials.gov
- NCT03333343
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with EGFR-mutant 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 · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 25 | 2 |
| Italy | Ended | 27 | 1 |
| Rest of world
Taiwan, Hong Kong, Singapore, Canada
|
— | 92 | — |
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 |
|---|---|---|---|---|---|
| Germany | 2018-04-13 | 2018-04-13 | 2021-04-12 | ||
| Italy | 2018-07-26 | 2025-05-15 | 2018-07-26 | 2021-04-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-42743
- Halt date
- 2024-07-05
- Member states concerned
- Germany
- Publication date
- 2024-08-27
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-42742
- Halt date
- 2024-07-05
- Member states concerned
- Italy
- Publication date
- 2024-08-27
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-21 | Italy | Acceptable 2024-07-04
|
2024-07-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-10 | Italy | Acceptable 2024-07-04
|
2025-01-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-05 | Italy | Acceptable 2025-05-26
|
2025-05-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-20 | Acceptable 2025-08-22
|
2025-08-27 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-10 | Italy | Acceptable 2025-08-22
|
2025-09-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-13 | Acceptable | 2025-11-05 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-12 | Acceptable 2026-02-10
|
2026-02-12 |