Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
61
Countries
3
Sites
7
EGFR-Mutant Non-Small Cell Lung Cancer
Key facts
- Sponsor
- BeOne Medicines AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 6 Jun 2025 → 22 Apr 2026
- Decision date (initial)
- 2025-05-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517322-26-00
- ClinicalTrials.gov
- NCT06685718
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
EGFR-Mutant Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BeOne Medicines AG
- Sponsor organisation
- BeOne Medicines AG
- Address
- Aeschengraben 27
- City
- Basel
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 1 | 1 |
| Italy | Ended | 6 | 3 |
| Spain | Ended | 6 | 3 |
| Rest of world
Korea, Republic of, China, Brazil, United States, New Zealand, Thailand, Australia, Malaysia
|
— | 48 | — |
Investigational sites
Universitaetsklinikum Ulm AöR
Comprehensive Cancer Center Ulm (CCCU), Early clinical trials unit, Albert-Einstein-Allee 23, Eselsberg, Ulm
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncolocy-Hematology Department, Via Pietro Albertoni 15, 40138, Bologna
Fondazione IRCCS San Gerardo Dei Tintori
UOC Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Hospital Universitario Puerta De Hierro De Majadahonda
Oncologia, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario 12 De Octubre
Oncologia, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Oncologia, 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 |
|---|---|---|---|---|---|
| Italy | 2025-07-04 | 2025-10-23 | |||
| Spain | 2025-06-06 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-17 | Italy | Acceptable 2025-05-09
|
2025-05-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-29 | Italy | Acceptable 2025-05-09
|
2025-08-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-20 | Italy | Acceptable 2025-11-07
|
2025-11-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-06 | Acceptable 2026-04-27
|
2026-04-30 |