Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
704
Countries
4
Sites
13
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
- 8 Sep 2020 → ongoing
- Decision date (initial)
- 2024-03-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506577-35-00
- EudraCT number
- 2020-000747-31
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
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
4 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 87 | 5 |
| Germany | Ongoing, recruitment ended | 30 | 3 |
| Italy | Ongoing, recruitment ended | 25 | 2 |
| Spain | Ongoing, recruitment ended | 67 | 3 |
| Rest of world
Japan, Korea, Republic of, Taiwan, United States, China
|
— | 495 | — |
Investigational sites
Institut Curie
Thoracic oncology, 26 Rue D Ulm, 75005, Paris
Direction Centrale Du Service De Sante Des Armees
ONCOLOGY, 69 Avenue De Paris, 94160, Saint-Mande
Institut Gustave Roussy
MEDICAL ONCOLOGY, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
MEDICAL ONCOLOGY, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Marseille
ONCOLOGY AND THERAPEUTIC INNOVATIONS, 265 Chemin Des Bourrely, 13015, Marseille
Pius-Hospital Oldenburg
Oncology, Georgstrasse 12, Innenstadt, Oldenburg
Universitaetsklinikum Essen AöR
Oncology, Hufelandstrasse 55, Holsterhausen, Essen
University Hospital Cologne AöR
Oncology, Kerpener Strasse 62, Lindenthal, Cologne
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Unità Clinica di Fase I, SC Sperimentazioni Cliniche, Via Mariano Semmola 52, 80131, Naples
European Institute Of Oncology S.r.l.
Oncologia Medica Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovativee, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| France | 2020-09-23 | 2020-09-30 | 2024-07-15 | ||
| Germany | 2021-02-05 | 2021-02-19 | 2024-05-02 | ||
| Italy | 2020-12-16 | 2021-05-04 | 2024-07-15 | ||
| Spain | 2020-09-08 | 2020-10-15 | 2024-07-15 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-25 | Italy | Acceptable 2024-03-12
|
2024-03-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-22 | Italy | Acceptable 2024-10-01
|
2024-10-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-11 | Acceptable | 2025-01-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-14 | Italy | Acceptable 2025-11-19
|
2025-11-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-16 | Italy | Acceptable 2026-03-03
|
2026-03-05 |