Clinical trial • Phase III • Oncology

Trastuzumab deruxtecan for Advanced breast cancer | Non-small cell lung cancer

Phase III trial of Trastuzumab deruxtecan for Advanced breast cancer | Non-small cell lung cancer. 76 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced breast cancer | Non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
ADC | Monoclonal antibody

Key dates

Initial CTIS Submission Date
03-10-2024
First CTIS Authorization Date
24-10-2024

Eligibility

Recruits 76 Vulnerable population not selected; no consent/assent details provided..

Vulnerable Population
Vulnerable population not selected; no consent/assent details provided.

Recruitment

Recruitment Window Months
74
Consent Approach
Informed consent process not provided in the record; no details on assent or language-specific documents.

Geography

Total Number Of Sites
4
Total Number Of Participants
76

France

Latest Decision Or Authorization Date
05-05-2026
Number Of Sites
2
Number Of Participants
45

Sites

Site Name
Oncopole Claudius Regaud
Department Name
Departement d’oncologie medicale
Contact Person Name
Julien MAZIERES
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Centre d’Essais Précoces en Cancérologie de Marseille (CEPCM)
Contact Person Name
Marie Meurer
Contact Person Email
marie.meurer@ap-hm.fr

Spain

Latest Decision Or Authorization Date
11-05-2026
Number Of Sites
2
Number Of Participants
31

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Medical Oncology
Contact Person Name
Maria Rosario Garcia Campelo

Sponsor

Primary sponsor

Full Name
Daiichi Sankyo Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
Trastuzumab Deruxtecan
Active Substance
Trastuzumab deruxtecan
Modality
ADC
Investigational Product Name
Pembrolizumab
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Combination Treatment
Yes

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