Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
126
Countries
2
Sites
5
Advanced non-small cell lung cancer
Key facts
- Sponsor
- Johnson And Johnson Enterprise Innovation Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Feb 2024 → ongoing
- Decision date (initial)
- 2024-01-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced non-small cell lung cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Johnson And Johnson Enterprise Innovation Inc.
- Sponsor organisation
- Johnson And Johnson Enterprise Innovation Inc.
- Address
- 1 Johnson And Johnson Plaza
- City
- New Brunswick
- Postcode
- 08933-0001
- Country
- United States
Scientific contact point
- Organisation
- Johnson And Johnson Enterprise Innovation Inc.
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Johnson And Johnson Enterprise Innovation Inc.
- Contact name
- CTIS Point of Contact
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 15 | 1 |
| Spain | Ongoing, recruitment ended | 35 | 4 |
| Rest of world
United States, Korea, Republic of
|
— | 76 | — |
Investigational sites
Justus-Liebig-Universitaet Giessen
Medizinische Klinik IV Organonkologie, Gaffkystrasse 5, 35392, Giessen
Instituto Oncologico Dr. Rosell S.L.
Medical Oncology, Calle De Sabino Arana Num. 5, 08028, Barcelona
Hospital Universitario Y Politecnico La Fe
Medical Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
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 | 2024-03-21 | 2024-04-25 | 2026-04-02 | ||
| Spain | 2024-02-13 | 2024-02-22 | 2026-04-02 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-12 | Germany | Acceptable 2024-01-15
|
2024-01-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-12 | Germany | Acceptable 2024-01-15
|
2024-09-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-10 | Germany | Acceptable 2025-02-06
|
2025-02-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-26 | Germany | Acceptable 2025-04-25
|
2025-04-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-12 | Germany | Acceptable 2025-04-25
|
2025-09-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-19 | Germany | Acceptable 2026-02-23
|
2026-02-26 |