Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
340
Countries
3
Sites
8
Metastatic Solid Tumor Advanced Solid Tumor Non-small Cell Lung Cancer SMARCA4-Deficient Tumor
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Nov 2025 → ongoing
- Decision date (initial)
- 2025-09-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519727-18-00
- WHO UTN
- U1111-1322-5086
- ClinicalTrials.gov
- NCT06561685
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Solid Tumor Advanced Solid Tumor Non-small Cell Lung Cancer SMARCA4-Deficient Tumor
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Locations
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 48 | 3 |
| Germany | Authorised, recruiting | 27 | 3 |
| Spain | Ongoing, recruiting | 37 | 2 |
| Rest of world
Switzerland, Japan, United States, Korea, Republic of
|
— | 228 | — |
Investigational sites
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
Department of Medicine / DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Krankenhaus Nordwest GmbH
Klinik für Onkologie und Hämatologie, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Universitaetsklinikum Essen AöR
Department of Medical Oncology, Hufelandstrasse 55, Holsterhausen, Essen
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 | 2025-12-10 | 2025-12-29 | |||
| Germany | 2026-05-19 | ||||
| Spain | 2025-11-25 | 2026-01-28 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-27 | France | Acceptable 2025-09-15
|
2025-09-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-25 | France | Acceptable | 2025-11-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-25 | Acceptable | 2025-10-29 |