Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion

Last updated: August 1, 2025
Sponsor: Groupe Francais De Pneumo-Cancerologie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Treatment

Blood sampling

Clinical Study ID

NCT06247826
GFPC 06-2023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients with advanced NSCLC with EGFR ins20 receiving amivantamab asmonotherapy in France under ATU or EAP;

  • Age ≥ 18 years;

  • Histologically confirmed advanced NSCLC (metastatic or locally advanced unresectableand not suitable for definitive radiotherapy) with EGFR ins20;

  • Patients included will be required to sign an informed consent form to collect bloodsamples (liquid biopsy) and tissue biopsy when available at progression onamivantamab;

  • 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

Exclusion Criteria:

  • Patients receiving amivantamab in combination with another therapy;

  • Patients who do not consent to liquid biopsy at progression.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Blood sampling
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Oncologie Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33000
    France

    Site Not Available

  • Centre Hospitalier du Morvan

    Brest, 29200
    France

    Active - Recruiting

  • Pneumologie Centre Hospitalier Intercommunal de Créteil

    Creteil, 94010
    France

    Active - Recruiting

  • Oncologie, CLCC Dijon

    Dijon, 21000
    France

    Site Not Available

  • Pneumologie, CHU Grenoble

    Grenoble, 38043
    France

    Active - Recruiting

  • Pneumologie CH

    Le Mans, 72000
    France

    Site Not Available

  • Oncologie thoracique Hôpital Nord

    Marseille, 13915
    France

    Active - Recruiting

  • Oncologie, Centre Antoine Lacassagne

    Nice, 06149
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 75014
    France

    Active - Recruiting

  • Oncologie Institut Curie

    Paris, 75005
    France

    Site Not Available

  • Pneumologie, Hôpital Tenon

    Paris, 75970
    France

    Active - Recruiting

  • Pneumologie Centre Hospitalier

    Pau, 64000
    France

    Site Not Available

  • Pneumologie CHI Cornouaille

    Quimper, 02900
    France

    Site Not Available

  • Hôpital Charles Nicolle

    Rouen, 76031
    France

    Active - Recruiting

  • CHU La Réunion Site Nord

    Saint-Denis, 97411
    France

    Active - Recruiting

  • CHU Hôpital Nord

    Saint-Étienne, 42055
    France

    Active - Recruiting

  • CH Bretagne Atlantique

    Vannes, 56017
    France

    Active - Recruiting

  • Pneumologie, Hôpital Mutualiste Resamut

    Villeurbanne, 69100
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.