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

Inclusion Criteria:

• Pathologically confirmed adenocarcinoma of the lung

• Locally advanced or metastatic NSCLC, not amenable to curative surgery orradiotherapy

• At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKIsensitivity (Ex19del or L858R), either alone or in combination with other EGFRmutations

• Treatment-naïve for locally advanced or metastatic NSCLC

• WHO performance status score of 0 to 1 with no clinically significant deteriorationover the previous 2 weeks before randomization

• At least 1 measurable lesion, not previously irradiated and not chosen for biopsyduring the study Screening period

Exclusion Criteria:

• Symptomatic and unstable brain metastases

• Leptomeningeal metastases

• Symptomatic spinal cord compression

• History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitiswhich 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 beforerandomization

• Any cardiovascular disease as follows:

• History of symptomatic chronic heart failure or serious cardiac arrhythmiarequiring active treatment

• History of myocardial infarction or unstable angina within 24 weeks ofrandomization