NCT06247826 Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
| NCT ID | NCT06247826 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe Francais De Pneumo-Cancerologie |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-01-15 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Pascale Tomasini
PRINCIPAL INVESTIGATOR
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM
Frequently Asked Questions
Who can join the NCT06247826 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06247826 currently recruiting?
Yes, NCT06247826 is actively recruiting participants. Contact the research team at laurent.greillier@ap-hm.fr for enrollment information.
Where is the NCT06247826 trial being conducted?
This trial is being conducted at Bordeaux, France, Brest, France, Créteil, France, Dijon, France and 11 additional locations.
Who is sponsoring the NCT06247826 clinical trial?
NCT06247826 is sponsored by Groupe Francais De Pneumo-Cancerologie. The principal investigator is Pascale Tomasini at Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM. The trial plans to enroll 30 participants.
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