Clinical trial • Phase III • Oncology
ceritinib for Non-small cell lung cancer
Phase III trial of ceritinib for Non-small cell lung cancer. 37 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 29-03-2024
- First CTIS Authorization Date
- 09-04-2024
Trial design
Phase III trial across 2 sites in Belgium, Spain.
- Target Sample Size
- 37
Eligibility
Recruits 37 isVulnerablePopulationSelected is true in the CTIS record; no further details on the vulnerable population type or consent/assent procedures are provided in the available data..
- Vulnerable Population
- isVulnerablePopulationSelected is true in the CTIS record; no further details on the vulnerable population type or consent/assent procedures are provided in the available data.
Recruitment
- Planned Sample Size
- 37
- Recruitment Window Months
- 142
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 23
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-02-2024
- Latest Decision Or Authorization Date
- 22-04-2024
- Processing Time Days
- 74
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- UZ Leuven
- Department Name
- #1200: Pneumology
- Principal Investigator Name
- Christophe Dooms
- Principal Investigator Email
- christophe.dooms@uzleuven.be
- Contact Person Name
- Christophe Dooms
- Contact Person Email
- christophe.dooms@uzleuven.be
- Number Of Participants
- 9
Spain
- Earliest CTIS Part Ii Submission Date
- 08-02-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 61
- Number Of Sites
- 1
- Number Of Participants
- 14
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #2000:Oncología
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Number Of Participants
- 14
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- Ceritinib
- Active Substance
- ceritinib
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Investigational Product Name
- Nivolumab
- Active Substance
- nivolumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous
- Combination Treatment
- Yes
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