Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
169
Countries
1
Sites
11
Small Cell Lung Cancer
Key facts
- Sponsor
- Zai Lab (US) LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Nov 2024 → ongoing
- Decision date (initial)
- 2024-10-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zai Lab (US) LLC
- Sponsor organisation
- Zai Lab (US) LLC
- Address
- 314 Main Street Ste 04-100
- City
- Cambridge
- Postcode
- 02142-1042
- Country
- United States
Scientific contact point
- Organisation
- Zai Lab (Shanghai) Co. Ltd.
- Contact name
- Yinjia Fu
Public contact point
- Organisation
- Zai Lab (Shanghai) Co. Ltd.
- Contact name
- Yinjia Fu
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 80 | 11 |
| Rest of world
United States, China
|
— | 89 | — |
Investigational sites
Vall D Hebron Institute Of Oncology
Oncology Department, Calle Natzaret 115, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology Department, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology Department, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Hm Nou Delfos
Oncology Department, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology Department, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
Oncology Department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Y Politecnico La Fe
Oncology Department, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Regional De Malaga
Oncology Department, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Quironsalud Madrid
Oncology Department, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Virgen De La Macarena
Oncology Department, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario 12 De Octubre
Oncology Department, Bloque D, Avenida De Cordoba Sn, Madrid
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 | 2024-11-21 | 2024-11-27 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-31 | Spain | Acceptable 2024-10-31
|
2024-10-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-11 | Spain | Acceptable 2024-10-31
|
2025-02-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-02 | Spain | Acceptable 2024-10-31
|
2025-04-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-16 | Spain | Acceptable 2024-10-31
|
2025-04-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-29 | Spain | Acceptable 2025-06-25
|
2025-06-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-07 | Spain | Acceptable 2025-06-25
|
2025-07-07 |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-08 | Spain | Acceptable 2025-08-11
|
2025-08-11 |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-10 | Spain | Acceptable 2025-12-26
|
2026-01-09 |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-19 | Spain | Acceptable 2026-04-06
|
2026-04-13 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-04-27 | Spain | Acceptable 2026-04-06
|
2026-04-27 |