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 considered a new, permanent, and mutant-selective epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). It has a demonstrated efficacy to treat patients experiencing EGFR-mutated non-small cell cancer (NSCLC). The present study aims to explore the clinical efficacy and safety of nazartinib in patients experiencing EGFR-mutated NSCLC. MATERIALS AND METHODS: The present study is a prospective, multicentre, open-label experiment seeking to assess the clinical safety as well as efficacy of nazartinib in patients suffering from EGFR-mutated NSCLC. The study will randomly divide 78 patients into experimental and control groups using a ratio of 1:1. Additionally, the study will treat the experimental group with nazartinib, and the control group with other chemotherapeutic agents. Besides, the study will treat both the experimental and control groups with standard treatment for a period of 14 days and will be followed up at least 24 weeks. Overall response rate is the major endpoint. Accordingly, the minor endpoints will include progression-free survival, response time, overall survival, and adverse events. Statistical analysis will be performed by SPSS 25.0 software. DISCUSSION: The study will investigate the clinical safety and efficacy of nazartinib in patients suffering from EGFR-mutated NSCLC. The anticipated results of the study are expected to provide clinical basis for nazartinib to treat patients suffering from EGFR-mutated NSCLC.