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Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program

Status: Recruiting
Location: See all (16) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
CH du Pays d Aix - Service des Maladies Respiratoires
RECRUITING
Aix-en-provence
APHP Hôpital Avicennes
RECRUITING
Bobigny
Hôpital Louis Pradel
ACTIVE_NOT_RECRUITING
Bron
Pneumologie Centre François Baclesse
ACTIVE_NOT_RECRUITING
Caen
Pneumologie Centre Hospitalier Intercommunal de Créteil
RECRUITING
Créteil
Hôpital A. Mignot
RECRUITING
Le Chesnay
Pneumologie Hôpital Calmette
RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
Pneumologie Hôpital privé Jean Mermoz
RECRUITING
Lyon
Hôpital Nord
RECRUITING
Marseille
CHRU de Nancy
ACTIVE_NOT_RECRUITING
Nancy
Centre Antoine Lacassagne
ACTIVE_NOT_RECRUITING
Nice
Institut Curie
ACTIVE_NOT_RECRUITING
Paris
CH de la Région d'Annecy - Service de Pneumologie
RECRUITING
Pringy
Pneumologie CHU St Etienne
RECRUITING
Saint-etienne
CHU La Réunion Site Sud
RECRUITING
Saint-pierre
Contact Information
Primary
Prof. Laurent Greillier
a.boucheix@g-f-p-c.org
+33 4 73 98 39 86
Backup
Soizic Ferlandin
soizic_ferlandin@yahoo.fr
+33 6 63 22 47 89
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2027-11-19
Participants
Target number of participants: 100
Treatments
Cohort 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.
Cohort 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.
Sponsors
Leads: GFPC Investigation

This content was sourced from clinicaltrials.gov

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