Overview
Sponsor-declared trial summary
Non-small cell lung cancer Oesophageal squamous cell carcinoma Renal cell carcinoma Squamous cell carcinoma of head and neck
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 Jun 2023 → 26 Jan 2026
- Decision date (initial)
- 2022-12-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-small cell lung cancer Oesophageal squamous cell carcinoma Renal cell carcinoma Squamous cell carcinoma of head and neck
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
| 21.0 | PT | 10061534 | Oesophageal squamous cell carcinoma | 100000004864 |
| 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
- EU Legal Representative
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- EU Legal Representative
Locations
5 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 17 | 1 |
| France | Ended | 13 | 1 |
| Germany | Ended | 19 | 1 |
| Italy | Ended | 18 | 1 |
| Spain | Ended | 21 | 1 |
| Rest of world
Singapore, Taiwan, United States, Japan
|
— | 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 | 2023-11-07 | 2023-11-07 | |||
| France | 2023-07-03 | 2023-07-03 | 2024-10-03 | ||
| Germany | 2023-06-27 | 2023-06-27 | |||
| Italy | 2023-04-17 | 2023-04-17 | 2024-10-03 | ||
| Spain | 2023-04-05 | 2023-04-05 | 2024-10-03 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-51341
- Halt date
- 2024-10-03
- Member states concerned
- Italy
- Publication date
- 2024-11-20
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-51338
- Halt date
- 2024-10-03
- Member states concerned
- Spain
- Publication date
- 2024-11-20
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-51335
- Halt date
- 2024-10-03
- Member states concerned
- France
- Publication date
- 2024-11-20
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-23 | Spain | Acceptable 2022-12-02
|
2022-12-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-01-31 | Acceptable | 2023-03-09 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-02-01 | Spain | Acceptable | 2023-02-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-02-02 | Acceptable | 2023-03-07 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-02-02 | Acceptable | 2023-03-17 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-02-02 | Acceptable | 2023-03-20 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-08-16 | Spain | Acceptable 2023-11-20
|
2023-11-20 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-05-27 | Spain | Acceptable 2024-07-18
|
2024-07-18 |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-09-13 | Spain | Acceptable 2024-10-17
|
2024-10-18 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-10 | Spain | Acceptable 2024-10-17
|
2024-12-10 |