Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
130
Countries
4
Sites
10
Non-small cell lung cancer (NSCLC)
Key facts
- Sponsor
- Oslo University Hospital Hf
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502640-12-01
- EudraCT number
- 2019-002537-11
- ClinicalTrials.gov
- NCT04392504
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-small cell lung cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital Hf
- Sponsor organisation
- Oslo University Hospital Hf
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital Hf
- Contact name
- Åslaug Helland
Public contact point
- Organisation
- Oslo University Hospital Hf
- Contact name
- Åslaug Helland
Locations
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Estonia | Ongoing, recruitment ended | 10 | 1 |
| Finland | Ongoing, recruitment ended | 15 | 3 |
| Lithuania | Ongoing, recruitment ended | 10 | 1 |
| Norway | Ongoing, recruitment ended | 95 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
North Estonia Medical Centre Foundation
Department of chemotherapy, clinic of oncology and haematology, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Turku University Hospital
Oncology department, Hameentie 11, 20520, Turku
Oulu University Hospital
department of oncology, Kajaanintie 50, 90220, Oulu
Tampere University Hospital
Department of oncology, Teiskontie 35, 33520, Tampere
Vilnius University Hospital
Oncology Department, Santariskiu G. 1, Vilniaus M. Sav., Vilnius
St. Olavs Hospital HF
Department of cancer research and molecular medicine, P. O. Box 3250, Torgarden, Trondheim
Helse Bergen HF
Avdeling for kreftbehandling og medisinsk fysikk, P. O. Box 1400, 5021, Bergen
Oslo University Hospital HF
Department of oncology, Taarnbygget, Kirkeveien 166, Oslo
University Hospital Of North Norway HF
Department of oncology and Department of pulmology, P. O. Box 100, 9038, Tromsoe
Stavanger University Hospital
Department of pulmonary medicine, Postboks 8100, 4068, Stavanger
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 |
|---|---|---|---|---|---|
| Estonia | 2024-09-27 | 2024-09-27 | 2024-12-15 | ||
| Finland | 2024-09-27 | 2024-09-27 | 2024-12-15 | ||
| Lithuania | 2024-10-23 | 2024-10-23 | 2024-12-15 | ||
| Norway | 2024-09-27 | 2024-09-27 | 2024-12-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-27 | Norway | Acceptable 2024-09-26
|
2024-09-27 |