Informations générales (source: ClinicalTrials.gov)
Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion (RESAMEX)
Interventional
N/A
Groupe Francais De Pneumo-Cancerologie (Voir sur ClinicalTrials)
janvier 2024
septembre 2025
11 juillet 2024
The goal of this prospective, interventional study is to evaluate the mechanisms of
acquired resistance to amivantamab monotherapy in patients with advanced NSCLC with EGFR
ins20. The main question it aims to answer is:
What are the mechanisms of acquired resistance to amivantamab monotherapy in this
population of patients ? How anticipate the efficacy of subsequent systemic therapies ?
After this information session, the participant will be asked to sign the study informed
consent. A blood samples (2*10 mL on ethylenediaminetetraacetic acid (EDTA)) will be
taken at time of disease progression and will be sent for central liquid biopsy ctDNA
analysis. If available, tumor tissue will also be sent for DNA NGS analysis.
Etablissements
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
AP-HP - Hôpital Cochin | Marie WISLEZ | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Tenon | Antony CANELLAS | Contact (sur clinicalTrials) | |||
CHI DE CRETEIL | Jean-Bernard AULIAC | Contact (sur clinicalTrials) | |||
CLCC INSTITUT CURIE | Elisa Gobbini | Contact (sur clinicalTrials) | |||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
Centre Hospitalier du Morvan - 29200 - Brest - France | Renaud DESCOURT, PhD | Contact (sur clinicalTrials) | |||
CH Bretagne Atlantique - 56017 - Vannes - France | Gonzague DE CHABOT | Contact (sur clinicalTrials) | |||
CHU Hôpital Nord - 42055 - Saint-Étienne - France | Sophie BAYLE-BLEUEZ | Contact (sur clinicalTrials) | |||
CHU La Réunion Site Nord - 97411 - Saint-Denis - France | Diane MOREAU | Contact (sur clinicalTrials) | |||
Hôpital Charles Nicolle - 76031 - Rouen - France | Florian GUISIER | Contact (sur clinicalTrials) | |||
Oncologie Polyclinique Bordeaux Nord Aquitaine - 33000 - Bordeaux - France | Camille MAZZA | Contact (sur clinicalTrials) | |||
Oncologie thoracique Hôpital Nord - 13915 - Marseille - France | Pascale Tomasini | Contact (sur clinicalTrials) | |||
Oncologie, Centre Antoine Lacassagne - 06149 - Nice - France | Josiane OTTO | Contact (sur clinicalTrials) | |||
Oncologie, CLCC Dijon - 21000 - Dijon - France | Loick GALLAND | Contact (sur clinicalTrials) | |||
Pneumologie Centre Hospitalier - 64000 - Pau - France | Aldo RENAULT | Contact (sur clinicalTrials) | |||
Pneumologie CH - 72000 - Le Mans - France | Olivier MOLINIER | Contact (sur clinicalTrials) | |||
Pneumologie CHI Cornouaille - 02900 - Quimper - France | Michel ANDRE | Contact (sur clinicalTrials) | |||
Pneumologie, CHU Grenoble - 38043 - Grenoble - France | Anne Claire TOFFART | Contact (sur clinicalTrials) | |||
Pneumologie, Hôpital Mutualiste Resamut - 69100 - Villeurbanne - France | Jean-Marc DOT | Contact (sur clinicalTrials) |
Critères
Tous
Inclusion Criteria:
- All patients with advanced NSCLC with EGFR ins20 receiving amivantamab as
monotherapy in France under ATU or EAP;
- Age ≥ 18 years;
- Histologically confirmed advanced NSCLC (metastatic or locally advanced unresectable
and not suitable for definitive radiotherapy) with EGFR ins20;
- Patients included will be required to sign an informed consent form to collect blood
samples (liquid biopsy) and tissue biopsy when available at progression on
amivantamab;
- Confirmed progression on amivantamab according to RECIST 1.1;
- Patient enrolled in the french National Health Insurance program or with a third-
party payer.
- All patients with advanced NSCLC with EGFR ins20 receiving amivantamab as
monotherapy in France under ATU or EAP;
- Age ≥ 18 years;
- Histologically confirmed advanced NSCLC (metastatic or locally advanced unresectable
and not suitable for definitive radiotherapy) with EGFR ins20;
- Patients included will be required to sign an informed consent form to collect blood
samples (liquid biopsy) and tissue biopsy when available at progression on
amivantamab;
- Confirmed progression on amivantamab according to RECIST 1.1;
- Patient enrolled in the french National Health Insurance program or with a third-
party payer.
- Patients receiving amivantamab in combination with another therapy;
- Patients who do not consent to liquid biopsy at progression.