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A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 Vs. a Standard of Care EGFR TKI, As First Line Treatment to EGFR Mutation Positive Advanced NSCLC with CNS Metastases

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A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 Vs. a Standard of Care EGFR TKI, As First Line Treatment to EGFR Mutation Positive Advanced NSCLC with CNS Metastases

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 26 Nov 2024

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At a glance

  • Drugs Zorifertinib (Primary) ; Erlotinib; Gefitinib
  • Indications Brain metastases; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EVEREST
  • Sponsors Alpha Biopharma

    • Most Recent Events

    • 20 Nov 2024 According to an Alpha Biopharma media release, based on results from this trial, the National Medical Products Administration (NMPA) has approved Zorifertinib Hydrochloride for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) accompanied with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous system (CNS) metastases.
    • 06 Jun 2023 Primary endpoint has been met (PFS assessed by Blinded Independent Central Radiological) , according to results presented at the 59th Annual Meeting of the American Society of Clinical Oncology
    • 06 Jun 2023 Results (as of 12 Jul 2022, at median follow-up 20.4 months) reporting safety and efficacy presented at the 59th Annual Meeting of the American Society of Clinical Oncology

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