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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2025

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At a glance

  • Drugs Lazertinib (Primary) ; Gefitinib
  • Indications Adenocarcinoma; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms LASER301
  • Sponsors Yuhan

Most Recent Events

  • 30 Apr 2025 Results assessing mechanisms of acquired resistance and circulating tumor DNA (ctDNA) clearance in pts who received Lazertinib, presented at the 116th Annual Meeting of the American Association for Cancer Research.
  • 13 Aug 2024 Planned End Date changed from 1 Jun 2024 to 1 Jun 2026.
  • 24 Oct 2023 Results (n=332) of an integrated analysis characterizing clinical features of paresthesia and related AEs, and examined effect of lazertinib dose reduction (DR) on drug exposure, safety and clinical efficacy presented at the 48th European Society for Medical Oncology Congress

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