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

RecruitingNAAges 18 Years - anyAllGroupe Francais De Pneumo-Cancerologie
NCT06247826 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Blood sampling
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Where

18 sites
Oncologie Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Centre Hospitalier du Morvan
Brest, France
Pneumologie Centre Hospitalier Intercommunal de Créteil
Créteil, France
Oncologie, CLCC Dijon
Dijon, France
Pneumologie, CHU Grenoble
Grenoble, France
Pneumologie CH
Le Mans, France
Oncologie thoracique Hôpital Nord
Marseille, France
Oncologie, Centre Antoine Lacassagne
Nice, France

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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