Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
232
Countries
1
Sites
2
Squamous-Cell Non-Small Cell Lung Cancer
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Sep 2025 → ongoing
- Decision date (initial)
- 2025-09-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518012-39-00
- ClinicalTrials.gov
- NCT06858813
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Squamous-Cell Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
| 24.0 | LLT | 10085300 | Squamous non-small cell lung cancer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 20 | 2 |
| Rest of world
Japan, China, Taiwan, Israel, Korea, Republic of, United States
|
— | 212 | — |
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 |
|---|---|---|---|---|---|
| Spain | 2025-09-22 | 2025-10-07 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-13 | Spain | Acceptable 2025-09-08
|
2025-09-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-08 | Spain | Acceptable 2026-02-20
|
2026-03-06 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-25 | Spain | Acceptable 2026-02-20
|
2026-03-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-30 | Spain | Acceptable 2026-05-18
|
2026-05-20 |