Clinical trial • Respiratory

pembrolizumab for Metastatic non-squamous non-small cell lung cancer|Non-small cell lung cancer

Clinical trial of pembrolizumab for Metastatic non-squamous non-small cell lung cancer|Non-small cell lung cancer. 1666 participants.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Metastatic non-squamous non-small cell lung cancer|Non-small cell lung cancer
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-01-2024
First CTIS Authorization Date
12-03-2024

Trial design

Clinical trial in France, Spain, Belgium.

Target Sample Size
1666

Recruitment

Planned Sample Size
1666
Recruitment Window Months
72

Geography

Total Number Of Participants
1666

France

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
12-03-2024
Processing Time Days
35
Number Of Participants
1166

Spain

Earliest CTIS Part Ii Submission Date
01-11-2024
Latest Decision Or Authorization Date
23-12-2024
Processing Time Days
52
Number Of Participants
300

Belgium

Earliest CTIS Part Ii Submission Date
04-02-2025
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
30
Number Of Participants
200

Sponsor

Primary sponsor

Full Name
Institut Gustave Roussy
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Pembrolizumab
Active Substance
pembrolizumab
Modality
Monoclonal antibody

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