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

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
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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