Clinical efficacy and safety of nazartinib for epidermal growth factor receptor mutated non-small cell lung cancer: Study protocol for a prospective, multicenter, open-label
Background: Nazartinib is a novel, irreversible, and mutant-selective epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). It has demonstrated effectiveness in treating patients with EGFR-mutated non-small cell lung cancer (NSCLC). This study aims to evaluate the clinical efficacy and safety of nazartinib in patients with EGFR-mutated NSCLC.
Materials and Methods: This prospective, multicenter, open-label study will assess the clinical safety and efficacy of nazartinib in patients with EGFR-mutated NSCLC. A total of 78 patients will be randomly EGF816 assigned in a 1:1 ratio to either the experimental group, receiving nazartinib, or the control group, receiving other chemotherapeutic agents. Both groups will also receive standard treatment over a 14-day period, with a follow-up of at least 24 weeks. The primary endpoint is the overall response rate, while secondary endpoints include progression-free survival, response duration, overall survival, and the occurrence of adverse events. Statistical analysis will be conducted using SPSS version 25.0.
Discussion: This study will explore the clinical safety and efficacy of nazartinib in patients with EGFR-mutated NSCLC. The expected results are anticipated to provide a clinical foundation for the use of nazartinib in treating patients with EGFR-mutated NSCLC.