Lazertinib is currently approved as a first-line treatment for EGFR-mutant NSCLC in South Korea. However, many patients experience peripheral neuropathy, which causes severe numbness, tingling, or painful muscle cramps. This side effect significantly lowers patients' quality of life and often leads to treatment interruptions. This phase 2, open-label, randomized clinical trial newly diagnosed EGFR mutant NSCLC patients is based on the hypothesis that a lower dose of lazertinib combined with magnesium supplementation will result in a more tolerable safety profile without compromising efficacy outcomes
Pathologically diagnosed pulmonary adenocarcinoma.
Patient with a stage not amenable to curative treatment by surgery or radiotherapy and requiring palliative chemotherapy.
Patient with no prior treatment history for lung cancer, or who relapsed >=6 months after curative-intent therapy (concurrent chemoradiotherapy or adjuvant chemotherapy) with no subsequent anticancer treatment - i.e., a candidate for first-line chemotherapy.
Patient with a confirmed EGFR mutation of Exon 19 deletion or L858R.
Subjects with confirmed leptomeningeal/CNS metastasis on brain MRI or cerebrospinal fluid examination.
Subjects with pre-existing peripheral neuropathy.
Subjects who are taking any agent that may affect the development of peripheral neuropathy for reasons other than peripheral neuropathy (magnesium, pregabalin, gabapentin, duloxetine) and refuse to discontinue its use.
Subjects for whom, in the physician's judgment, participation in this study would carry greater harm than benefit (no specific items specified).