Participants will receive Ensartinib at 225 mg orally once a day (QD). Treatments will continue until disease progression, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy). At the time of disease progression, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Collection of venous blood sample from participants included 3 times: before treatment, 8 weeks of treatment, and disease progression. Blood specimens of 8 ml were collected each time for ctDNA NGS testing, and evaluation of Ensartinib population pharmacokinetics with blood sampling after 8 weeks.
The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.