X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: X-396 capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer. Evidence of positive ALK. Patients must have demonstrated progression during or after crizotinib treatment. Age 18 years or older at the time of informed consent. Eastern cooperative oncology group performance status (ECOG PS) of 0-2 Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). Asymptomatic CNS metastases do not require the use of steroids or anticonvulsants. Willingness and ability to comply with the trial and follow-up procedures. Ability to understand the nature of this trial and give written informed consent. Exclusion Criteria: Prior use of ALK TKIs with the exception of crizotinib. Patients currently receiving cancer system therapy. Use of an investigational drug within 4 weeks prior to the first dose of study drug. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. Patients with a known allergy or delayed hypersensitivity reaction to drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: X-396 capsule<br>225mg once daily | Drug: X-396 capsule<br>* 225mg once daily<br>* Other names: Ensartinib;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 36 months | 
| Overall survival (OS) | OS, defined as time from first dose of X-396 to death due to any cause. | 36 months |