Overview
Sponsor-declared trial summary
Advanced non-small cell lung cancer with or without NFE2L2/KEAP1/CUL3 mutations in adult patients
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
- 25 Nov 2022 → 14 Oct 2025
- Decision date (initial)
- 2023-12-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504350-36-00
- EudraCT number
- 2021-006793-22
- ClinicalTrials.gov
- NCT05275868
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced non-small cell lung cancer with or without NFE2L2/KEAP1/CUL3 mutations in adult patients
| 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 Town
- 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 · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 25 | 3 |
| Spain | Ended | 25 | 2 |
| Rest of world
United States, Korea, Republic of, Switzerland, Japan
|
— | 70 | — |
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 | 2022-11-25 | 2022-11-25 | 2025-09-30 | ||
| Spain | 2025-07-15 | 2025-07-15 | 2025-09-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-101413
- Halt date
- 2025-09-30
- Member states concerned
- Spain
- Publication date
- 2025-10-09
- Reason
- Sponsor decision
- Explanation
- Business reasons
- Follow-up measures
- Patients currently on study will continue on study as per approved protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-101416
- Halt date
- 2025-09-30
- Member states concerned
- Germany
- Publication date
- 2025-10-09
- Reason
- Sponsor decision
- Explanation
- Business reasons
- Follow-up measures
- Patients currently on study will continue on study as per approved protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-24 | Spain | Acceptable 2023-12-12
|
2023-12-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-04 | Spain | Acceptable 2024-08-29
|
2024-08-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-22 | Acceptable 2024-08-29
|
2025-01-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-30 | Spain | Acceptable 2025-03-04
|
2025-03-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-26 | Spain | Acceptable 2025-07-09
|
2025-07-10 |