Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
385
Countries
4
Sites
18
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 · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 70 | 7 |
| Germany | Ongoing, recruiting | 32 | 4 |
| Netherlands | Ongoing, recruiting | 13 | 1 |
| Spain | Ongoing, recruiting | 70 | 6 |
| Rest of world
United States, Taiwan, Korea, Republic of
|
— | 200 | — |
Investigational sites
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncopole Claudius Regaud IUCT-O, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut De Cancerologie De L Ouest
Site René Gauducheau, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional De Marseille
Centre d'Essais en Cancérologie de Marseille (CEPCM-CLIPP), 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Lille
Pneumology and Thoracic Oncology, Boulevard Du Professeur Jules Leclercq, 59000, Lille
LMU Klinikum Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Goethe University Frankfurt
Medizinische Klinik II Hämatologie/Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Technische Universitaet Dresden
Nationales Centrum für Tumorerkrankungen Dresden, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Klinik für Onkologie und Hämatologie, Hindenburgdamm 30, Lichterfelde, Berlin
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Regional De Malaga
Oncologia Medica, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Virgen Del Rocio S.L.
Oncologia Medica, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital San Pedro
Oncology, Calle Piqueras 98, 26006, Logrono
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
12 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 |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-25 | Netherlands | Acceptable with conditions 2026-06-29
|
2026-06-30 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-07-07 | Netherlands | Acceptable with conditions 2026-06-29
|
2026-07-07 |