Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
40
Countries
2
Sites
7
Locally advanced or metastatic NSCLC
Key facts
- Sponsor
- Astellas Pharma Global Development Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522398-12-00
- ClinicalTrials.gov
- NCT07140016
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced or metastatic NSCLC
| 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
Astellas Pharma Global Development Inc.
- Sponsor organisation
- Astellas Pharma Global Development Inc.
- Address
- 2375 Waterview Drive
- City
- Northbrook
- Postcode
- 60062-6145
- Country
- United States
Scientific contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Taisa Paluch-Kassenberg
Public contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Taisa Paluch-Kassenberg
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 6 | 3 |
| Spain | Ongoing, recruiting | 6 | 4 |
| Rest of world
Japan, United States
|
— | 28 | — |
Investigational sites
Oncopole Claudius Regaud
Medical Oncology Department, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Gustave Roussy
MEDICAL ONCOLOGY, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Regional De Malaga
Medical Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
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 |
|---|---|---|---|---|---|
| Spain | 2026-01-30 | 2026-03-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-04 | Spain | Acceptable 2026-01-14
|
2026-01-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-20 | Spain | Acceptable 2026-01-14
|
2026-03-20 |