Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
20
Countries
1
Sites
2
Advanced KRASG12C-mutated non-small cell lung cancer subjects who previosly progressed on at least one prior line of therapy, or who have contraindications for immuno/chemotherapy.
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-10-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515250-25-00
- EudraCT number
- 2022-002322-27
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced KRASG12C-mutated non-small cell lung cancer subjects who previosly progressed on at least one prior line of therapy, or who have contraindications for immuno/chemotherapy.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10069759 | KRAS mutation | 10018065 |
| 22.0 | LLT | 10075674 | KRAS codon 12 and 13 mutation | 10018065 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | LLT | 10025044 | Lung cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Karin Lindberg
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Karin Lindberg
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 20 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Sweden | Acceptable 2024-10-25
|
2024-10-25 |