Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
251
Countries
4
Sites
11
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Key facts
- Sponsor
- Pierre Fabre Medicament
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506759-51-00
- ClinicalTrials.gov
- NCT06043817
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10029514 | Non-small cell lung cancer NOS | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pierre Fabre Medicament
- Sponsor organisation
- Pierre Fabre Medicament
- Address
- Les Cauquillous
- City
- Lavaur
- Postcode
- 81500
- Country
- France
Scientific contact point
- Organisation
- Scorpion Therapeutics Inc.
- Contact name
- Corporate Scientific and Medical information
Public contact point
- Organisation
- Scorpion Therapeutics Inc.
- Contact name
- Corporate Scientific and Medical information
Locations
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 46 | 4 |
| Germany | Ongoing, recruiting | 23 | 2 |
| Netherlands | Ongoing, recruiting | 13 | 1 |
| Spain | Ongoing, recruiting | 46 | 4 |
| Rest of world
United States, Korea, Republic of, Taiwan
|
— | 123 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Site René Gauducheau, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncopole Claudius Regaud IUCT-O, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
Département Oncologie Médicale, 26 Rue D Ulm, 75005, Paris
Charite Universitaetsmedizin Berlin KöR
Klinik für Onkologie und Hämatologie, Hindenburgdamm 30, Lichterfelde, Berlin
Technische Universitaet Dresden
Nationales Centrum für Tumorerkrankungen Dresden, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Regional De Malaga
Oncologia Medica, Avenida De Carlos De Haya S/N, 29010, Malaga
University Hospital Virgen Del Rocio S.L.
Oncologia Medica, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2024-03-29 | 2024-06-27 | |||
| Germany | 2024-05-29 | 2025-01-06 | |||
| Netherlands | 2024-04-26 | 2024-08-15 | |||
| Spain | 2024-04-18 | 2024-06-28 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-10 | Netherlands | Acceptable with conditions 2024-02-19
|
2024-02-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-27 | Netherlands | Acceptable 2024-04-22
|
2024-04-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-12 | Netherlands | Acceptable 2024-09-30
|
2024-09-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-23 | Netherlands | Acceptable 2024-09-30
|
2024-10-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-07 | Netherlands | Acceptable 2025-04-04
|
2025-04-04 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-25 | Netherlands | Acceptable 2025-04-04
|
2025-04-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-30 | Netherlands | Acceptable 2025-05-07
|
2025-05-07 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-24 | Netherlands | Acceptable 2025-07-29
|
2025-07-29 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-15 | Netherlands | Acceptable 2025-10-30
|
2025-10-31 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-11 | Netherlands | Acceptable 2026-02-24
|
2026-02-24 |