Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
3
Sites
22
Non-small Cell Lung Cancer (NSCLC)
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Feb 2025 → 20 Feb 2025
- Decision date (initial)
- 2024-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511030-12-00
- WHO UTN
- U1111-1302-9694
- ClinicalTrials.gov
- NCT05828303
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-small Cell Lung Cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 21.1 | PT | 10029517 | Non-small cell lung cancer stage I | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Locations
3 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Not authorised | 5 | 7 |
| Italy | Ended | 3 | 4 |
| Spain | Ended | 9 | 11 |
| Rest of world
Australia, Brazil, United States
|
— | 7 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Oncology, 15 Rue Andre Boquel, 49100, Angers
Centre Hospitalier Regional De Marseille
Oncology, 265 Chemin Des Bourrely, 13015, Marseille
Institut Bergonie
Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Universitaire De Poitiers
Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire Grenoble Alpes
Oncology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Nantes
Oncology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Rennes
Oncology, 2 Rue Henri Le Guilloux, 35000, Rennes
Humanitas Mirasole S.p.A.
U.O. Di Oncologia ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale Santa Maria Della Misericordia - Azienda Ospedaliera di Perugia
S.C. di Oncologia Medica, via Dottori 1, 06132, Perugia
Centro Ricerche Cliniche Di Verona S.r.l.
U.O.C. Oncologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Centro Di Riferimento Oncologico Di Aviano
S.O.C. Oncologia medica e dei tumori immuno-correlati, Via Franco Gallini 2, 33081, Aviano
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 28040, 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 |
|---|---|---|---|---|---|
| Spain | 2025-02-03 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-16 | France | Acceptable 2024-11-27
|
2024-11-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-17 | Acceptable 2024-11-27
|
2024-12-17 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-19 | Acceptable 2024-11-27
|
2024-12-19 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-29 | France | Acceptable 2024-11-27
|
2025-01-29 |