Clinical trial • Phase I • Oncology

Clinical trial in Metastatic Solid Tumor | Advanced Solid Tumor | Non-small cell lung cancer | SMARCA4-deficient tumor

Phase I trial for Metastatic Solid Tumor | Advanced Solid Tumor | Non-small cell lung cancer | SMARCA4-deficient tumor. 228 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic Solid Tumor | Advanced Solid Tumor | Non-small cell lung cancer | SMARCA4-deficient tumor
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
27-05-2025
First CTIS Authorization Date
15-09-2025

Trial design

Phase I trial across 8 sites in Spain, France, Germany.

Target Sample Size
228

Recruitment

Planned Sample Size
228
Recruitment Window Months
38

Geography

Total Number Of Sites
8
Total Number Of Participants
112

Spain

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
13
Number Of Sites
2
Number Of Participants
37

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Victor Moreno
Contact Person Email
Victor.moreno@startmadrid.com

France

Earliest CTIS Part Ii Submission Date
11-06-2025
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
145
Number Of Sites
3
Number Of Participants
48

Sites

Site Name
Institut Gustave Roussy
Department Name
Department of Medicine / DITEP
Contact Person Name
Rastislav BAHLEDA
Site Name
Institut Curie
Department Name
Pneumology
Contact Person Name
Nicolas GIRARD
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Institut Bergonie
Department Name
Medical Oncology
Contact Person Name
Antoine ITALIANO

Germany

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
29-10-2025
Processing Time Days
47
Number Of Sites
3
Number Of Participants
27

Sites

Site Name
Krankenhaus Nordwest GmbH
Department Name
Klinik für Onkologie und Hämatologie
Contact Person Name
Akin Atmaka
Contact Person Email
atmaca.akin@khnw.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie
Contact Person Name
Damian Rieke
Contact Person Email
damian.rieke@charite.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of Medical Oncology
Contact Person Name
Martin Schuler
Contact Person Email
martin.schuler@uk-essen.de

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

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