Clinical trial • Phase III • Oncology

trastuzumab deruxtecan for HER2-positive advanced or metastatic non-small cell lung cancer

Phase III trial of trastuzumab deruxtecan for HER2-positive advanced or metastatic non-small cell lung cancer. 180 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-positive advanced or metastatic non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
ADC|Small molecule|Other

Key dates

Initial CTIS Submission Date
11-09-2024
First CTIS Authorization Date
14-11-2024

Trial design

Phase III trial in Poland, France, Italy.

Biomarker Stratified
True: HER2 overexpression (HER2) - patients selected for HER2 overexpression
Target Sample Size
180

Eligibility

Recruits 180 Vulnerable population selected; no details on consent or assent handling provided in source..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling provided in source.

Recruitment

Planned Sample Size
180
Recruitment Window Months
75

Geography

Total Number Of Sites
10
Total Number Of Participants
52

Poland

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
577
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Osrodek Badan Klinicznych Wczesnych Faz
Contact Person Name
Rafal Dziadziuszko
Contact Person Email
rafald@gumed.edu.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddzial Onkologii z Pododdzialem chemioterapii
Contact Person Name
Jaroslaw Kolb-Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuc i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
dariusz.kowalski@nio.gov.pl

France

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
570
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Département d'Oncologie Médicale
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Département d'Oncologie Médicale
Contact Person Name
François Ghiringhelli
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Hospices Civils De Lyon
Department Name
Département d'Oncologie Médicale
Contact Person Name
Michael Duruisseaux
Site Name
Institut Gustave Roussy
Department Name
Département d'Oncologie Médicale
Contact Person Name
David Planchard

Italy

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
575
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Oncologia Medica
Contact Person Name
Diego Cortinovis
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Ematologia e Oncologia - Struttura Complessa Oncologia Falck
Contact Person Name
Salvatore Siena
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Trastuzumab deruxtecan
Active Substance
trastuzumab deruxtecan
Modality
ADC
Combination Treatment
Yes

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