Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer

NCT07563205 | Recruiting

• 3 other identifiers: OMAE GFPC 02-2024CNRIPH National numberCPP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer NSCLC; Non Small Cell Lung Carcinoma; NSCLC; EGFR; EGFR Exon 19 Deletion Mutation; EGFR Exon 21 Mutation; Non-Small Cell Lung Cancer; EGFR Exon 20 Insertion Mutation

Keywords

Lung Cancer; Non Small Cell lung cancer; Metastatic lung cancer; EGFR Exon 20; EGFR Exon 19; EGFR Exon 21; NSCLC

Outcome Measures

Primary Outcomes (2)

• Investigator Progression Free Survival (Investigator PFS)

  The Investigator Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let at the investigator 's discretion as per local practices. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.

  From the date of first dose of combination treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

• Independent Panel Progression Free Survival (Independent Panel PFS)

  The Independent Panel Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progressionnt defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 centrally by an independent panel based on images provided by the site. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.

  From the date of first dose of treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

Secondary Outcomes (22)

• Baseline Clinical Characteristics

  At Baseline visit, on a maximum period of 12 months

• Overall Survival (OS)

  Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum

• Investigator Objective Response Rate (Investigator ORR)

  From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

• Independent Panel Objective Response Rate (Independent Panel ORR)

  From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

• Adverse events

  From the combination treatment start date up to a 2-year-period maximum

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Principal investigator of GFPC or partner centers will identify consecutive patients eligible for the inclusion from the patient population of their center (public hospital or private clinics).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GFPC Investigation: lead

Study Sites (16)

CH du Pays d Aix - Service des Maladies Respiratoires

Aix-en-Provence, 13616, France

RECRUITING

APHP Hôpital Avicennes

Bobigny, 93000, France

RECRUITING

Hôpital Louis Pradel

Bron, 69500, France

ACTIVE NOT RECRUITING

Pneumologie Centre François Baclesse

Caen, 14000, France

ACTIVE NOT RECRUITING

Pneumologie Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

RECRUITING

Hôpital A. Mignot

Le Chesnay, 78157, France

RECRUITING

Pneumologie Hôpital Calmette

Lille, 59000, France

RECRUITING

Pneumologie Hôpital privé Jean Mermoz

Lyon, 69085, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Hôpital Nord

Marseille, 13915, France

RECRUITING

CHRU de Nancy

Nancy, 54000, France

ACTIVE NOT RECRUITING

Centre Antoine Lacassagne

Nice, 06149, France

ACTIVE NOT RECRUITING

Institut Curie

Paris, 75005, France

ACTIVE NOT RECRUITING

CH de la Région d'Annecy - Service de Pneumologie

Pringy, 74374, France

RECRUITING

Pneumologie CHU St Etienne

Saint-Etienne, 42270, France

RECRUITING

CHU La Réunion Site Sud

Saint-Pierre, 97410, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Prof. Jean-Bernard Auliac

  Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil

  PRINCIPAL INVESTIGATOR

• Dr Thomas Pierret

  Service de Pneumologie - Hôpital Louis Pradel GH Est-HCL

  PRINCIPAL INVESTIGATOR

• Prof. Christos Chouaïd

  Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil

  STUDY CHAIR

Central Study Contacts

Prof. Laurent Greillier

CONTACT

+33 4 73 98 39 86; a.boucheix@g-f-p-c.org

Soizic Ferlandin

CONTACT

+33 6 63 22 47 89; soizic_ferlandin@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 1, 2026
• Study Start: November 19, 2025
• Primary Completion (Estimated): November 19, 2027
• Study Completion (Estimated): November 19, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

FR (16)