Clinical trial • Phase II • Oncology
SB27 for Non-small cell lung cancer
Phase II trial of SB27 for Non-small cell lung cancer. 94 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 22-09-2023
- First CTIS Authorization Date
- 19-01-2024
Trial design
Phase II trial across 6 sites in Spain, Poland.
- Target Sample Size
- 94
Eligibility
Recruits 94 Vulnerable population selected; no details on consent or assent handling provided in the source..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided in the source.
Recruitment
- Planned Sample Size
- 94
- Recruitment Window Months
- 31
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 41
Spain
- Earliest CTIS Part Ii Submission Date
- 17-01-2024
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 764
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Hospital Universitario Severo Ochoa
- Department Name
- Oncology
- Contact Person Name
- Anna Lopez Martin
- Contact Person Email
- almartin@salud.madrid.org
- Site Name
- Hospital Universitario De Jaen
- Department Name
- Oncology
- Contact Person Name
- Jose Antonio Lopez Lopez
- Contact Person Email
- jall92hs@gmail.com
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Oncology
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuelcobodols@yahoo.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Contact Person Name
- Luis Angel Leon Mateos
- Contact Person Email
- Luis.Angel.Leon.Mateos@sergas.es
Poland
- Earliest CTIS Part Ii Submission Date
- 12-01-2024
- Latest Decision Or Authorization Date
- 22-02-2026
- Processing Time Days
- 772
- Number Of Sites
- 2
- Number Of Participants
- 23
Sites
- Site Name
- Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
- Department Name
- Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
- Contact Person Name
- Aleksandra Szczęsna
- Contact Person Email
- ola_szczesna@outlook.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
- Contact Person Name
- Anna Kowalczyk
- Contact Person Email
- akow@gumed.edu.pl
Sponsor
Primary sponsor
- Full Name
- Samsung Bioepis Co. Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Korea, Republic of
Investigational products
- Investigational Product Name
- SB27
- Modality
- Monoclonal antibody
- Investigational Product Name
- Keytruda (EU sourced)
- Modality
- Monoclonal antibody
- Investigational Product Name
- Keytruda (US sourced)
- Modality
- Monoclonal antibody
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