Clinical trial • Phase III • Oncology

furmonertinib for Non-small cell lung cancer (EGFR- or HER2-mutant) | HER2-positive non-small cell lung cancer | Metastatic non-small cell lung cancer

Phase III trial of furmonertinib for Non-small cell lung cancer (EGFR- or HER2-mutant) | HER2-positive non-small cell lung cancer | Metastatic non-small c…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (EGFR- or HER2-mutant) | HER2-positive non-small cell lung cancer | Metastatic non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-06-2024
First CTIS Authorization Date
11-07-2024

Trial design

Phase III trial across 10 sites in France, Italy, Spain and others.

Biomarker Stratified
True: biomarker EGFR and HER2; strata: EGFR-mutant, HER2-mutant
Target Sample Size
130

Eligibility

Recruits 130 Vulnerable population selected; no details on consent or assent handling provided..

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

Recruitment

Planned Sample Size
130
Recruitment Window Months
54

Geography

Total Number Of Sites
10
Total Number Of Participants
32

France

Latest Decision Or Authorization Date
22-04-2026
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Institut Gustave Roussy
Department Name
Medecine Oncologique
Contact Person Name
David Planchard
Site Name
Centre Leon Berard
Department Name
Oncologie Medicale
Contact Person Name
Maurice Perol
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie Medicale
Contact Person Name
Julien Mazieres
Contact Person Email
mazieresjulien@gmail.com

Italy

Latest Decision Or Authorization Date
03-03-2025
Number Of Sites
2
Number Of Participants
1

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncology
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it

Spain

Latest Decision Or Authorization Date
27-04-2026
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
MD Anderson Cancer Center
Department Name
Oncology
Contact Person Name
FERNANDO FABIO FRANCO PEREZ
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
OSCAR JOSÉ JUAN VIDAL
Contact Person Email
Juan_osc@gva.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
START Madrid - CIOCC
Contact Person Name
RAMON YARZA BARRIO
Contact Person Email
Ramon.Yarza@startmadrid.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Thoracic and H&N Oncology Unit, Oncology department
Contact Person Name
ENRIQUETA FELIP FONT
Contact Person Email
efelip@vhio.net

Netherlands

Latest Decision Or Authorization Date
24-04-2026
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
MOD, Thoracic-Oncology
Contact Person Name
Adrianus Johannes (Joop) de Langen
Contact Person Email
j.d.langen@nki.nl

Sponsor

Primary sponsor

Full Name
Arrivent Biopharma Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
Furmonertinib
Active Substance
furmonertinib
Modality
Small molecule

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