Trial Title:
Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
NCT ID:
NCT06247826
Condition:
Non-small Cell Lung Cancer
EGFR Exon 20 Insertion Mutation
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Blood sampling
Description:
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.
Arm group label:
Experimental arm
Summary:
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.
Detailed description:
RESAMEX is a prospective study evaluating the mechanisms of acquired resistance to
amivantamab monotherapy in patients with advanced NSCLC with EGFR ins20. Biological
analysis will be performed on circulating tumor deoxyribonucleic acid (ctDNA) at the time
of disease progression and on tumor tissue at the time of disease progression when
available.
- ctDNA : The extraction of the ctDNA will be performed in an automated way with the
Promega RSC LV cfDNA kit on Maxwell platform. Sequencing will be performed on
NextSeq500 platform with a panel of 208 genes (including 190 genes with full
coverage of coding regions, and 11 genes with coverage of introns involved in
translocations) covering 800 kpb and at a target depth of 8000 X.
- Tissue : Deoxyribonucleic acid (DNA) next generation sequencing (NGS) will be
performed on tumor biopsy (10 slides of 5 microns) .
Samples will be sent for centralized analysis to Centre de Recherche en Cancérologie de
Marseille (CRCM), 27 Bd Lei Roure, 13009 Marseille (Prof. Tomasini and Gwenaël Lumet),
and will be stored at Centre de Ressources Biologiques de l'Assistance Publique Hôpitaux
de Marseille (CRB AP-HM), 264 Rue Saint-Pierre, 13005 Marseille.
Criteria for eligibility:
Criteria:
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.
Exclusion Criteria:
- Patients receiving amivantamab in combination with another therapy;
- Patients who do not consent to liquid biopsy at progression.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncologie Polyclinique Bordeaux Nord Aquitaine
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Camille MAZZA
Email:
c.mazza@bordeauxnord.com
Facility:
Name:
Centre Hospitalier du Morvan
Address:
City:
Brest
Zip:
29200
Country:
France
Status:
Recruiting
Contact:
Last name:
Renaud DESCOURT, PhD
Phone:
+33 298223827
Email:
renaud.descourt@chu-brest.fr
Investigator:
Last name:
Renaud DESCOURT, PhD
Email:
Principal Investigator
Facility:
Name:
Pneumologie Centre Hospitalier Intercommunal de Créteil
Address:
City:
Creteil
Zip:
94010
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean-Bernard AULIAC
Email:
jean-bernard.auliac@chicreteil.fr
Investigator:
Last name:
Jean-Bernard AULIAC
Email:
Principal Investigator
Facility:
Name:
Oncologie, CLCC Dijon
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Loick GALLAND
Email:
lgalland@cgfl.fr
Facility:
Name:
Pneumologie, CHU Grenoble
Address:
City:
Grenoble
Zip:
38043
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anne Claire TOFFART
Email:
atoffart@chu-grenoble.fr
Facility:
Name:
Pneumologie CH
Address:
City:
Le Mans
Zip:
72000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Olivier MOLINIER
Email:
omolinier@ch-lemans.fr
Facility:
Name:
Oncologie thoracique Hôpital Nord
Address:
City:
Marseille
Zip:
13915
Country:
France
Status:
Recruiting
Contact:
Last name:
Pascale Tomasini
Email:
pascale.tomasini@ap-hm.fr
Facility:
Name:
Oncologie, Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06149
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Josiane OTTO
Email:
josiane.otto@nice.unicancer.fr
Facility:
Name:
Oncologie Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Elisa Gobbini
Email:
elisa.gobbini@curie.fr
Facility:
Name:
Hôpital Cochin
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie WISLEZ
Email:
marie.wislez@aphp.fr
Facility:
Name:
Pneumologie, Hôpital Tenon
Address:
City:
Paris
Zip:
75970
Country:
France
Status:
Recruiting
Contact:
Last name:
Antony CANELLAS
Email:
anthony.canellas@aphp.fr
Facility:
Name:
Pneumologie Centre Hospitalier
Address:
City:
Pau
Zip:
64000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aldo RENAULT
Email:
also.renault@ch-pau.fr
Facility:
Name:
Pneumologie CHI Cornouaille
Address:
City:
Quimper
Zip:
02900
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Michel ANDRE
Email:
michel.andré@ch-cornouaille.fr
Facility:
Name:
Hôpital Charles Nicolle
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Recruiting
Contact:
Last name:
Florian GUISIER
Email:
florian.guisier@chu-rouen.fr
Investigator:
Last name:
Florian GUISIER
Email:
Principal Investigator
Facility:
Name:
CHU La Réunion Site Nord
Address:
City:
Saint-Denis
Zip:
97411
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Diane MOREAU
Email:
diane.moreau@chu-reunion.fr
Investigator:
Last name:
Diane MOREAU
Email:
Principal Investigator
Facility:
Name:
CHU Hôpital Nord
Address:
City:
Saint-Étienne
Zip:
42055
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sophie BAYLE-BLEUEZ
Email:
sophie.bayle@chu-st-etienne.fr
Investigator:
Last name:
Sophie BAYLE-BLEUEZ
Email:
Principal Investigator
Facility:
Name:
CH Bretagne Atlantique
Address:
City:
Vannes
Zip:
56017
Country:
France
Status:
Recruiting
Contact:
Last name:
Gonzague DE CHABOT
Email:
gonzague.dechabot@ch-bretagne-atlantique.fr
Facility:
Name:
Pneumologie, Hôpital Mutualiste Resamut
Address:
City:
Villeurbanne
Zip:
69100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-Marc DOT
Email:
j.dot@resamut.fr
Start date:
January 15, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Groupe Francais De Pneumo-Cancerologie
Agency class:
Other
Source:
Groupe Francais De Pneumo-Cancerologie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06247826
