Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
313
Countries
4
Sites
18
Advanced non-small cell lung cancer
Key facts
- Sponsor
- BioNTech SE
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Apr 2022 → ongoing
- Decision date (initial)
- 2024-02-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509283-14-00
- EudraCT number
- 2021-004739-94
- ClinicalTrials.gov
- NCT05142189
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced non-small cell lung cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BioNTech SE
- Sponsor organisation
- BioNTech SE
- Address
- An Der Goldgrube 12, Oberstadt Oberstadt
- City
- Mainz
- Postcode
- 55131
- Country
- Germany
Scientific contact point
- Organisation
- BioNTech SE
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- BioNTech SE
- Contact name
- Clinical Trial Information Desk
Locations
4 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 27 | 4 |
| Hungary | Ongoing, recruiting | 34 | 3 |
| Poland | Ongoing, recruiting | 31 | 3 |
| Spain | Ongoing, recruiting | 64 | 8 |
| Rest of world
United States, United Kingdom, Turkey, Australia
|
— | 157 | — |
Investigational sites
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Krankenhaus Nordwest GmbH
Klinik für Onkologie und Hämatologie, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Med. Klinik, Langenbeckstrasse 1, Oberstadt, Mainz
Clinexpert Kft.
Fázis 1 Vizsgálóhely, Dozsa Gyorgy Utca 15, 3200, Gyongyos
Orszagos Onkologiai Intezet
“B” Belgyógyászat-Onkológiai és Klinikai Farmakológiai Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Semmelweis University
Belgyógyászati és Onkológiai Klinika (Klinikai Farmakológiai Részleg, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Onkologii i pododdziałem chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Med Polonia Sp. z o.o.
NA/ND, Obornicka 262, 60-693, Poznan
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Germans Trias I Pujol
Oncology, Carretera Canyet 1a Planta, 08916, Badalona
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 |
|---|---|---|---|---|---|
| Germany | 2022-11-09 | 2022-11-15 | |||
| Hungary | 2022-04-25 | 2022-06-17 | |||
| Poland | 2023-03-08 | 2023-08-30 | |||
| Spain | 2023-03-23 | 2023-04-19 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-19 | Germany | Acceptable 2024-01-31
|
2024-02-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-16 | Germany | Acceptable 2024-07-22
|
2024-07-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-18 | Germany | Acceptable 2025-04-14
|
2025-04-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-12 | Germany | Acceptable 2025-11-17
|
2025-11-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-18 | Germany | Acceptable 2026-03-09
|
2026-03-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-19 | Acceptable | 2026-04-02 |