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

Condition(s) studied

Study 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

Primary outcome measure(s)

• Investigator Progression Free Survival (Investigator PFS) — 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
  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) — 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
  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.

Trial sites (16)

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