Clinical trial • Phase I • Oncology

Lenvatinib for Squamous non-small cell lung cancer|Hepatocellular carcinoma

Phase I trial of Lenvatinib for Squamous non-small cell lung cancer|Hepatocellular carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Squamous non-small cell lung cancer|Hepatocellular carcinoma
Trial Stage
Phase I
Drug Modality
Other|Small molecule

Key dates

Initial CTIS Submission Date
13-06-2025
First CTIS Authorization Date
09-09-2025

Trial design

Oral Lenvatinib Capsules; dose and schedule not specified-controlled Phase I trial across 2 sites in Spain.

Comparator
Oral Lenvatinib Capsules; dose and schedule not specified
Target Sample Size
212

Recruitment

Planned Sample Size
212
Recruitment Window Months
59

Geography

Total Number Of Sites
2
Total Number Of Participants
212

Spain

Earliest CTIS Part Ii Submission Date
17-07-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
232
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncología
Contact Person Name
Manuel Pedregal Trujillo
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncología
Contact Person Name
Irene Moreno Candilejo
Contact Person Email
irene.moreno@startmadrid.com

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
ABBV-324
Modality
Other
Routes Of Administration
Intravenous infusion
Investigational Product Name
Lenvatinib (oral lenvatinib capsules)
Active Substance
Lenvatinib
Modality
Small molecule
Routes Of Administration
Oral

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