Study of Ensartinib Treatment in Advanced ALK-Positive Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are studying the use of Ensartinib in people with advanced ALK-positive non-small cell lung cancer NSCLC. The study aims to evaluate how well Ensartinib works and its safety, as well as to understand how the drug moves through the body and how resistance to it may develop. This research is observational and focuses on patients whose cancer has progressed after previous ALK-TKI treatments. Participants will take Ensartinib orally at a dose of 225 mg once daily. Treatment continues until the disease worsens or if certain conditions like patient choice, side effects, or pregnancy occur. When the disease progresses, patients enter a follow-up period to monitor survival until death, withdrawal, or study end. Blood samples will be collected three times before starting treatment, after 8 weeks, and at disease progression, to analyze genetic material and drug levels. During the study, participants will undergo routine blood tests and assessments of their cancer status. Researchers will track progression-free survival over 36 months as the main outcome. They will also measure response rates, overall survival up to 48 months, and record any adverse events. This comprehensive monitoring helps evaluate how patients respond to Ensartinib and understand the safety of treatment over time.

A Real World Study of Ensartinib in Advanced ALK-positive NSCLC