The main purpose of the study is to evaluate safety and efficacy of X-396(Ensartinib) capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.
This is a phase II, multicenter, single-arm study in which the safety and efficacy of X-396(Ensartinib) will be assessed in adult Chinese patients with ALK-positive(rearrangement) non-small cell lung cancer previously treated with crizotinib. Approximately 144 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
152
225mg once daily
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital,Capital Medical University
Beijing, China
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking Union College Hospital
Beijing, China
Objective response rate (ORR) based on independent radiology review
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Time frame: 24 months
ORR based on investigator assessment
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Time frame: 24 months
Progression-free survival (PFS) as assessed by independent radiology review and investigator
PFS, defined as time from first dose of X-396 to progression or death due to any cause.
Time frame: 36 months
Overall survival (OS)
OS, defined as time from first dose of X-396 to death due to any cause.
Time frame: 36 months
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