Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Francais De Pneumo-Cancerologie
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Patients receiving amivantamab in combination with another therapy;
Patients who do not consent to liquid biopsy at progression.
Trial design
Design model
Single group
Treatments tested in this trial
Blood sampling
Procedure/SurgeryBlood 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of molecular alterations
Percentage of molecular alterations found at the time of disease progression on amivantamab monotherapy in patients with advanced NSCLC with EGFR ins20.
Time frame
At disease progression on a period up to 18 months at maximumSecondary outcomes
1
Progression Free Survival
Progression free survival with the first subsequent therapy after amivatamab, defined as the time from first dose to first documentation of objective disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause.
Time frame
From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever came first, assessed up to 18 monthsSponsors and contacts
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Source ClinicalTrials.gov