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A Phase III,Double-Blind, Randomised Study to Assess the Efficacy and Safety of ASK120067 Versus Gefitinib as First-Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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Trial Profile

A Phase III,Double-Blind, Randomised Study to Assess the Efficacy and Safety of ASK120067 Versus Gefitinib as First-Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 May 2025

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At a glance

  • Drugs Limertinib (Primary) ; Gefitinib
  • Indications Adenocarcinoma; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Jiangsu Aosaikang Pharmaceutical

Most Recent Events

  • 26 Apr 2025 According to Innovent Biologics media release, Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences is principal investigator of the Phase 3 clinical study.
  • 26 Apr 2025 According to Innovent Biologics media release, National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib as the first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer. The approval of this new indication is supported by positive results from a randomized, double-blind, positive-controlled Phase 3 clinical trial.
  • 17 Jan 2025 Results presented in an Innovent Biologics media release

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