Understanding resistance to amivantamab in lung cancer patients
Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
This study is trying to understand why some lung cancer patients with a specific mutation stop responding to the drug amivantamab, by looking at their blood and tumor samples after their disease gets worse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Francais De Pneumo-Cancerologie Academic / other |
| Drugs / interventions | amivantamab |
| Locations | 18 sites (Bordeaux and 17 other locations) |
| Trial ID | NCT06247826 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the mechanisms of acquired resistance to amivantamab monotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have an EGFR exon 20 insertion mutation. Participants will provide blood samples for circulating tumor DNA (ctDNA) analysis and, when available, tumor tissue samples for DNA next-generation sequencing (NGS) at the time of disease progression. The study seeks to identify how resistance develops and how it may inform future systemic therapies for these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced NSCLC and an EGFR exon 20 insertion mutation who are receiving amivantamab as monotherapy.
Not a fit: Patients receiving amivantamab in combination with other therapies or those who do not consent to liquid biopsy at progression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of resistance mechanisms, potentially guiding more effective treatment strategies for patients with advanced NSCLC.
How similar studies have performed: While this study focuses on a specific resistance mechanism, similar studies have shown promise in understanding treatment resistance in cancer therapies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bordeaux and 17 other locations
- Oncologie Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Not_yet_recruiting)
- Centre Hospitalier du Morvan — Brest, France (Recruiting)
- Pneumologie Centre Hospitalier Intercommunal de Créteil — Créteil, France (Recruiting)
- Oncologie, CLCC Dijon — Dijon, France (Not_yet_recruiting)
- Pneumologie, CHU Grenoble — Grenoble, France (Recruiting)
- Pneumologie CH — Le Mans, France (Not_yet_recruiting)
- Oncologie thoracique Hôpital Nord — Marseille, France (Recruiting)
- Oncologie, Centre Antoine Lacassagne — Nice, France (Withdrawn)
- Oncologie Institut Curie — Paris, France (Not_yet_recruiting)
- Hôpital Cochin — Paris, France (Recruiting)
- Pneumologie, Hôpital Tenon — Paris, France (Recruiting)
- Pneumologie Centre Hospitalier — Pau, France (Not_yet_recruiting)
- Pneumologie CHI Cornouaille — Quimper, France (Not_yet_recruiting)
- Hôpital Charles Nicolle — Rouen, France (Recruiting)
- CHU La Réunion Site Nord — Saint-Denis, France (Recruiting)
- CHU Hôpital Nord — Saint-Etienne, France (Recruiting)
- CH Bretagne Atlantique — Vannes, France (Recruiting)
- Pneumologie, Hôpital Mutualiste Resamut — Villeurbanne, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Pascale Tomasini — Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM
- Study coordinator: Laurent GRELLIER
- Email: laurent.greillier@ap-hm.fr
- Phone: +33 (0)4 91 96 59 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.