Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
232
Countries
3
Sites
10
Advanced or metastatic non-squamous non-small lung cancer (mNSCLC) with human epidermal growth factor receptor 2 (HER2) overexpression (OE)
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
- 1 Dec 2021 → ongoing
- Decision date (initial)
- 2024-11-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504949-31-00
- EudraCT number
- 2020-003260-31
- ClinicalTrials.gov
- NCT04686305
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic non-squamous non-small lung cancer (mNSCLC) with human epidermal growth factor receptor 2 (HER2) overexpression (OE)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10084785 | HER2 positive non-small cell lung cancer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- 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
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 12 | 4 |
| Italy | Ongoing, recruiting | 10 | 3 |
| Poland | Ongoing, recruiting | 30 | 3 |
| Rest of world
Taiwan, Australia, Canada, Singapore, China, Malaysia, Thailand, Israel, Philippines, Brazil, United States, Turkey, Korea, Republic of
|
— | 180 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Département d'Oncologie Médicale, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Hospices Civils De Lyon
Département d'Oncologie Médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centr Georges Francois Leclerc
Département d'Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Institut Gustave Roussy
Département d'Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
ASST Grande Ospedale Metropolitano Niguarda
Ematologia e Oncologia - Struttura Complessa Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
U.O.C. Oncologia Medica, Via Mariano Semmola 52, 80131, Naples
Fondazione IRCCS San Gerardo Dei Tintori
S.C. Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Uniwersyteckie Centrum Kliniczne
Osrodek Badan Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuc i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddzial Onkologii z Pododdzialem chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
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 | 2022-07-25 | 2022-11-21 | |||
| Italy | 2021-12-01 | 2022-03-10 | |||
| Poland | 2022-04-12 | 2022-05-24 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-11 | France | Acceptable 2024-11-14
|
2024-11-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-04 | France | Acceptable 2025-04-16
|
2025-04-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-18 | France | Acceptable 2025-11-07
|
2025-11-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-18 | France | Acceptable 2026-04-23
|
2026-04-23 |