Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer
Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program
This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Francais De Pneumo-Cancerologie Academic / other |
| Drugs / interventions | amivantamab, osimertinib, chemotherapy |
| Locations | 16 sites (Aix-en-Provence and 15 other locations) |
| Trial ID | NCT07563205 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study collects real-world outcomes from adults with metastatic NSCLC who receive amivantamab plus platinum-based chemotherapy through an early access program. It enrolls two cohorts: Cohort A includes patients with EGFR exon 20 insertions treated with the combination as first-line therapy, and Cohort B includes patients with EGFR exon 19 or 21 mutations treated with the combination after prior osimertinib. Investigators will record time to disease progression (progression-free survival), other clinical outcomes, and safety events using routine clinical data. The study is non-randomized and aims to describe effectiveness and tolerability across participating French hospitals.
Who should consider this trial
Good fit: Adults with metastatic NSCLC who have an EGFR exon 20 insertion receiving amivantamab plus platinum chemotherapy in first line, or adults with EGFR exon 19 or 21 mutations receiving the combination after osimertinib, and who are covered by French National Health Insurance or an approved payer.
Not a fit: Patients without the specified EGFR mutations, those with earlier-stage disease, or people not receiving amivantamab through the early access program are unlikely to be eligible or to benefit from this study.
Why it matters
Potential benefit: If successful, the study could show that adding amivantamab to chemotherapy helps people with EGFR-mutant metastatic NSCLC stay progression-free longer and clarify the combination's real-world safety.
How similar studies have performed: Prior clinical trials have shown activity of amivantamab in EGFR exon 20–mutant NSCLC, but combining amivantamab with platinum chemotherapy in these exact real-world settings is less well documented and is the focus of this observational effort.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years old * Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting. * Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program. * Patient covered by the French National Health Insurance system or by an approved third-party payer * Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required) Exclusion Criteria: * Patient placed under legal guardianship or subject to a protective legal measure * Patient who explicitly refuses the collection or use of their personal data for research purposes * Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator
Where this trial is running
Aix-en-Provence and 15 other locations
- CH du Pays d Aix - Service des Maladies Respiratoires — Aix-en-Provence, France (Recruiting)
- APHP Hôpital Avicennes — Bobigny, France (Recruiting)
- Hôpital Louis Pradel — Bron, France (Active_not_recruiting)
- Pneumologie Centre François Baclesse — Caen, France (Active_not_recruiting)
- Pneumologie Centre Hospitalier Intercommunal de Créteil — Créteil, France (Recruiting)
- Hôpital A. Mignot — Le Chesnay, France (Recruiting)
- Pneumologie Hôpital Calmette — Lille, France (Recruiting)
- Pneumologie Hôpital privé Jean Mermoz — Lyon, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Hôpital Nord — Marseille, France (Recruiting)
- CHRU de Nancy — Nancy, France (Active_not_recruiting)
- Centre Antoine Lacassagne — Nice, France (Active_not_recruiting)
- Institut Curie — Paris, France (Active_not_recruiting)
- CH de la Région d'Annecy - Service de Pneumologie — Pringy, France (Recruiting)
- Pneumologie CHU St Etienne — Saint-Etienne, France (Recruiting)
- CHU La Réunion Site Sud — Saint-Pierre, France (Recruiting)
Study contacts
- Principal investigator: Prof. Jean-Bernard Auliac — Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil
- Study coordinator: Prof. Laurent Greillier
- Email: a.boucheix@g-f-p-c.org
- Phone: +33 4 73 98 39 86
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.