Clinical trial • Phase I/II • Oncology
Pembrolizumab for Non-small cell lung cancer
Phase I/II trial of Pembrolizumab for Non-small cell lung cancer. 84 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase I/II
- Drug Modality
- ADC|Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 17-05-2024
- First CTIS Authorization Date
- 21-06-2024
Trial design
Phase I/II trial across 5 sites in Italy, Spain.
- Target Sample Size
- 84
Recruitment
- Planned Sample Size
- 84
- Recruitment Window Months
- 62
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 37
Italy
- Latest Decision Or Authorization Date
- 26-06-2024
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Oncologia medica
- Principal Investigator Name
- Diego Cortinovis
- Principal Investigator Email
- diegoluigi.cortinovis@irccs-sangerardo.it
- Contact Person Name
- Diego Cortinovis
- Contact Person Email
- diegoluigi.cortinovis@irccs-sangerardo.it
Spain
- Latest Decision Or Authorization Date
- 21-06-2024
- Number Of Sites
- 4
- Number Of Participants
- 32
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Domine Gomez
- Principal Investigator Email
- MDomine@fjd.es
- Contact Person Name
- Manuel Domine Gomez
- Contact Person Email
- MDomine@fjd.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- enriqueta.felip@vallhebron.cat
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- enriqueta.felip@vallhebron.cat
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Medical Oncology
- Principal Investigator Name
- Mariano Provencio Pulla
- Principal Investigator Email
- mprovencio.ensayosclinicos@gmail.com
- Contact Person Name
- Mariano Provencio Pulla
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Luis Paz-Ares Rodriguez
- Principal Investigator Email
- lpazaresr@seom.org
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
Sponsor
Primary sponsor
- Full Name
- Daiichi Sankyo Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Dato-DXd
- Modality
- ADC
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Platinum chemotherapy
- Modality
- Small molecule
- Combination Treatment
- Yes
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