AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients With EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    126
  • sponsor
    Michael Hopp
Updated on 31 January 2021

Summary

This randomized, open label Phase IV trial will be performed in patients with a diagnosis of advanced NSCLC (non-squamous cell histology), harboring EGFR mutation positive but T790M Mutation negative, who have no previous chemotherapy for metastatic NSCLC. Neoadjuvant or adjuvant systemic treatments had to be finished at least () 6 months before study inclusion. In conclusion, this study is investigating the important clinical question whether tumor growth and long term overall survival for a patient is better controlled in a specific treatment sequence of different EGFR-inhibitors. Patients will be treated with registered compounds according to their label in both treatment arms. Thus, all patients will get an effective treatment regimen and patients who progressed on afatinib, and who developed a T790M mutation will be treated subsequently with osimertinib. Those who progressed under osimertinib or under afatinib without T790M mutation will be treated according to the current treatment guidelines with Investigators choice of active therapy (ICT) including but not limited to platin doublet chemotherapy.

Details
Condition Non-squamous NSCLC, Non-squamous NSCLC, Non-squamous NSCLC
Treatment Afatinib, Osimertinib
Clinical Study IdentifierNCT04413201
SponsorMichael Hopp
Last Modified on31 January 2021

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