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 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

Exclusion Criteria:

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