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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Oncologie Polyclinique Bordeaux Nord Aquitaine
NOT_YET_RECRUITING
Bordeaux
Centre Hospitalier du Morvan
RECRUITING
Brest
Pneumologie Centre Hospitalier Intercommunal de Créteil
RECRUITING
Créteil
Oncologie, CLCC Dijon
NOT_YET_RECRUITING
Dijon
Pneumologie, CHU Grenoble
RECRUITING
Grenoble
Pneumologie CH
NOT_YET_RECRUITING
Le Mans
Oncologie thoracique Hôpital Nord
RECRUITING
Marseille
Oncologie, Centre Antoine Lacassagne
WITHDRAWN
Nice
Hôpital Cochin
RECRUITING
Paris
Oncologie Institut Curie
NOT_YET_RECRUITING
Paris
Pneumologie, Hôpital Tenon
RECRUITING
Paris
Pneumologie Centre Hospitalier
NOT_YET_RECRUITING
Pau
Pneumologie CHI Cornouaille
NOT_YET_RECRUITING
Quimper
Hôpital Charles Nicolle
RECRUITING
Rouen
CHU La Réunion Site Nord
RECRUITING
Saint-denis
CHU Hôpital Nord
RECRUITING
Saint-etienne
CH Bretagne Atlantique
RECRUITING
Vannes
Pneumologie, Hôpital Mutualiste Resamut
NOT_YET_RECRUITING
Villeurbanne
Contact Information
Primary
Laurent GRELLIER
laurent.greillier@ap-hm.fr
+33 (0)4 91 96 59 01
Backup
Soizic Ferlandin
soizic_ferlandin@yahoo.fr
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 30
Treatments
Experimental: Experimental arm
Patients presenting advanced NSCLC with EGFR ins20 already treated with amivantamab as monotherapy in France under Temporary Use Authorisation or Early Access Program who will accept to provide blood samples at disease progression.
Sponsors
Leads: Groupe Francais De Pneumo-Cancerologie

This content was sourced from clinicaltrials.gov

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