Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients

Exclusion Criteria

• •Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed)
• •Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment)
• •Uncontrolled central nervous system metastases- patient with asymptomatic brain metastases or CNS symptom manageable with TKI and evaluated by investigator can be enrolled.
• •Spinal cord compression, leptomeningeal carcinomatosis
• •Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
• •Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week
• •Any unresolved toxicities from prior therapy, greater than CTCAE grade 1
• •Mean QT interval corrected for heart rate (QTc) ≥ 470 ms
• •No measurable lesion
• •Unable to swallow the product due to refractory nausea, vomiting or chornic gastrointestinal disease.