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A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

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Trial Profile

A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 Apr 2024

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At a glance

  • Drugs Lazertinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Acronyms LASER201
  • Sponsors Janssen Research & Development; Yuhan

    • Most Recent Events

    • 01 Apr 2024 Results from long term follow up published in the Lung Cancer
    • 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
    • 01 Jan 2023 Results assessing Effects of food and race on the pharmacokinetics of lazertinib (from 3 studies NCT03556436: Healthy subjects N = 24; NCT03046992 n=30 Asian subjects and NCT04075396, n=22 non Asian patients NSCLC patients ) in healthy subjects and patients with EGFR mutation-positive advanced non-small cell lung cancer published in the Lung Cancer

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