Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

Other illness

• History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
• Any medical conditions requiring chronic continuous oxygen therapy
• History of any malignancy other than the disease under study within 3 years before randomization
• Any cardiovascular disease as follows:
  • History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment
  • History of myocardial infarction or unstable angina within 24 weeks of randomization

Other

• Symptomatic and unstable brain metastases
• Leptomeningeal metastases
• Symptomatic spinal cord compression

• Pathologically confirmed adenocarcinoma of the lung
• Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
• At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
• Treatment-naïve for locally advanced or metastatic NSCLC
• WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
• At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period