Clinical trial • Phase III • Oncology

Clinical trial in Non-small cell lung cancer|EGFR-mutant non-small cell lung cancer

Phase III trial for Non-small cell lung cancer|EGFR-mutant non-small cell lung cancer. 92 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer|EGFR-mutant non-small cell lung cancer
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
21-06-2024
First CTIS Authorization Date
05-07-2024

Trial design

Phase III trial across 3 sites in Germany, Italy.

Biomarker Stratified
True, biomarker: EGFR mutation (EGFR-mutant)
Target Sample Size
92

Recruitment

Planned Sample Size
92
Recruitment Window Months
96

Geography

Total Number Of Sites
3
Total Number Of Participants
52

Germany

Latest Decision Or Authorization Date
05-11-2025
Number Of Sites
2
Number Of Participants
25

Sites

Site Name
University Hospital Cologne AöR
Department Name
#2001:​Klinik I fuer Innere Medizin
Contact Person Name
Juergen Wolf
Contact Person Email
juergen.wolf@uk-koeln.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
​​#2002:Westdeutsches Tumorzentrum
Contact Person Name
Martin Schuler
Contact Person Email
martin.schuler@uk-essen.de

Italy

Latest Decision Or Authorization Date
10-06-2025
Number Of Sites
1
Number Of Participants
27

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
4001: Clinica di Oncologia Medica
Contact Person Name
Rossana Berardi

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Combination Treatment
Yes

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