Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
33
Countries
2
Sites
12
metastatic squamous non-small cell lung cancer
Key facts
- Sponsor
- CureVac SE
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 11 May 2026
- Decision date (initial)
- 2025-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
metastatic squamous non-small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10085300 | Squamous non-small cell lung cancer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CureVac SE
- Sponsor organisation
- CureVac SE
- Address
- Leipziger Strasse 35, Bierstadt Bierstadt
- City
- Wiesbaden
- Postcode
- 65191
- Country
- Germany
Scientific contact point
- Organisation
- CureVac SE
- Contact name
- Julia Bosch
Public contact point
- Organisation
- CureVac SE
- Contact name
- Julia Bosch
Locations
2 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 18 | 7 |
| Spain | Ended | 12 | 5 |
| Rest of world
United States
|
— | 3 | — |
Investigational sites
Institut Bergonie
n/a, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Regional De Marseille
n/a, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Rennes
Service de pneumologie Pneumology department, 2 Rue Henri Le Guilloux, 35000, Rennes
Institut Gustave Roussy
n/a, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
Oncologie Médicale, 26 Rue D Ulm, 75005, Paris
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut De Cancerologie De L Ouest
Medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Hospital Universitario Virgen De La Victoria
Oncología Médica, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitari Vall D Hebron
Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Quironsalud Barcelona
NEXT Oncology Barcelona, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncología, Unidad de Fase I START Madrid-CIOCC, Calle Ona 10, 28050, Madrid
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-17 | France | Acceptable 2025-05-28
|
2025-06-03 |