Clinical trial • Phase I | Phase III • Oncology
Durvalumab for Metastatic non-small cell lung cancer | Non-small cell lung cancer stage IV
Phase I | Phase III trial of Durvalumab for Metastatic non-small cell lung cancer | Non-small cell lung cancer stage IV. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic non-small cell lung cancer | Non-small cell lung cancer stage IV
- Trial Stage
- Phase I | Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 15-05-2024
- First CTIS Authorization Date
- 03-06-2024
Trial design
None/Not specified-controlled Phase I | Phase III trial across 2 sites in Poland.
- Comparator
- None/Not specified
- Target Sample Size
- 125
Eligibility
Recruits 125 Vulnerable population selected: true; no details on consent or assent handling provided in source..
- Vulnerable Population
- Vulnerable population selected: true; no details on consent or assent handling provided in source.
Recruitment
- Planned Sample Size
- 125
- Recruitment Window Months
- 87
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 44
Poland
- Earliest CTIS Part Ii Submission Date
- 09-04-2024
- Latest Decision Or Authorization Date
- 20-12-2024
- Processing Time Days
- 255
- Number Of Sites
- 2
- Number Of Participants
- 44
Sites
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Principal Investigator Name
- Bogdan Żurawski
- Principal Investigator Email
- bzur1@wp.pl
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- bzur1@wp.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej
- Principal Investigator Name
- Dariusz Kowalski
- Principal Investigator Email
- dariusz.kowalski@coi.pl
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- dariusz.kowalski@coi.pl
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Durvalumab
- Active Substance
- Durvalumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Combination Treatment
- Yes
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