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.
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 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
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).
Cohort
Other
Not listed
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.
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.
Baseline Clinical Characteristics
Baseline Clinical Characteristics as defined by baseline patient clinical characteristics (e.g. medical history, comorbidity, potential professional exposure, past history of cancer or auto-immune disease, smoking status, NSCLC or SCLC characteristics)
Overall Survival (OS)
OS is defined as the time from date of initiation of treatment combination initiation to date of death from any cause. Patients alive (or lost to follow up) at the time of analysis will be censored at the date they were last known to be alive.
Investigator Objective Response Rate (Investigator ORR)
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by the investigator using thorax-abdominal-pelvic and brain CT scans. The frequency of the tumor assessments will follow the site practices.
Independent Panel Objective Response Rate (Independent Panel ORR)
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by the independent panel based on thorax-abdominal-pelvic and brain CT scans provided by the sites.
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