Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
169
Countries
1
Sites
2
Metastatic Non-Small Cell Lung Cancer (NSCLC)
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 May 2019 → 10 Feb 2026
- Decision date (initial)
- 2024-06-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511956-42-00
- EudraCT number
- 2018-001748-74
- ClinicalTrials.gov
- NCT03819465
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Non-Small Cell Lung Cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10029522 | Non-small cell lung cancer stage IV | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 44 | 2 |
| Rest of world
Taiwan, Russian Federation, United States, Canada, Thailand, Korea, Republic of
|
— | 125 | — |
Investigational sites
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
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 |
|---|---|---|---|---|---|
| Poland | 2019-05-14 | 2026-02-10 | 2019-05-15 | 2024-06-04 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-15 | Poland | Acceptable 2024-05-29
|
2024-06-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-31 | Poland | Acceptable 2024-12-16
|
2024-12-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-09 | Poland | Acceptable 2025-07-14
|
2025-07-18 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-12 | Poland | Acceptable 2025-07-14
|
2025-11-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-03 | Poland | Acceptable 2026-05-08
|
2026-05-11 |