This is a Phase 2, multicenter, single-arm, open label study of AB-106 in the Chinese patients of NSCLC harboring with ROS1 fusion gene.~The study will consist of 2 parts. The Part 1 portion will evaluate the safety and PK profile of AB-106 by using two doses of 400mg QD and 600mg QD in order to confirm 600mg QD as the most optimal dose.~The Part 2 portion will evaluate the efficacy and safety of AB-106 by using the most optimal dose of 600mg QD.~It is expected to enroll 6 patients in Part 1 and 100 patients in Part 2. The study period of each patient will be comprised of screening, treatment, safety follow-up and survival follow-up.~In the Part 1 portion, 3 patients will receive AB-106 400mg QD and 3 patients will receive AB-106 600mg QD in 21-cycles to evaluate the safety and PK profiles.~In the Part 2 portion, 100 patients will be enrolled and divided into 2 cohorts. 60 crizotinib-naïve patients will be enrolled in Cohort A and 40 crizotinib-pretreated patients will be enrolled in Cohort B.~AB-106 will be administered 600mg once daily in 21-day cycles. Patients will continue with the study treatment until progression of disease as determined by the investigator.~The tumor response evaluation will be conducted in every two cycles in the first 8 cycles, and then every four cycles until progression of disease as determined by the investigator. The long-term survival follow up will be conducted every 12 weeks.
The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of AB-106 monotherapy in the treatment of advanced NSCLC.