Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
660
Countries
2
Sites
7
Advanced Non-Small Cell Lung Cancer
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Feb 2019 → ongoing
- Decision date (initial)
- 2024-04-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509435-11-00
- EudraCT number
- 2018-003908-38
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
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 7 | 6 |
| Italy | Ongoing, recruitment ended | 1 | 1 |
| Rest of world
United States, Canada, Australia, China, Korea, Republic of, United Kingdom, Japan, Taiwan
|
— | 652 | — |
Investigational sites
Institut Curie
Thoracic oncology, 26 Rue D Ulm, 75005, Paris
Assistance Publique Hopitaux De Marseille
ONCOLOGY AND THERAPEUTIC INNOVATIONS, 265 Chemin Des Bourrely, 13015, Marseille
Centr Georges Francois Leclerc
MEDICAL ONCOLOGY, 1 Rue Professeur Marion, 21000, Dijon
Institut De Cancerologie De L Ouest
Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Gustave Roussy
MEDICAL ONCOLOGY, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
MEDICAL ONCOLOGY, 28 Rue Laennec, 69008, Lyon
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 |
|---|---|---|---|---|---|
| France | 2019-02-21 | 2019-02-21 | 2022-12-22 | ||
| Italy | 2020-06-03 | 2020-06-03 | 2022-11-03 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | France | Acceptable 2024-04-29
|
2024-04-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-29 | France | Acceptable 2024-10-09
|
2024-10-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-14 | France | Acceptable 2025-10-27
|
2025-10-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-08 | France | Acceptable 2026-01-28
|
2026-01-28 |