Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer
Recruiting · NCT07563205 · Observational (researchers observe without assigning treatment) · Lead sponsor: GFPC Investigation
View the official record on ClinicalTrials.gov →What this trial is about
The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations. The study includes two groups of people: * Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program. * Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program. The main question the study wants to answer is: How long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people? People already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025. No extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.
Who can take part
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 it is running
16 locations listed.
- CH du Pays d Aix - Service des Maladies Respiratoires - Aix-en-Provence, France
- APHP Hôpital Avicennes - Bobigny, France
- Hôpital Louis Pradel - Bron, France
- Pneumologie Centre François Baclesse - Caen, France
- Pneumologie Centre Hospitalier Intercommunal de Créteil - Créteil, France
- Hôpital A. Mignot - Le Chesnay, France
- Pneumologie Hôpital Calmette - Lille, France
- Pneumologie Hôpital privé Jean Mermoz - Lyon, France
- Centre Léon Bérard - Lyon, France
- Hôpital Nord - Marseille, France
- CHRU de Nancy - Nancy, France
- Centre Antoine Lacassagne - Nice, France
- Institut Curie - Paris, France
- CH de la Région d'Annecy - Service de Pneumologie - Pringy, France
- Pneumologie CHU St Etienne - Saint-Etienne, France
- CHU La Réunion Site Sud - Saint-Pierre, France