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

Study Overview
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Brief Summary
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The main purpose of the study is to evaluate safety and efficacy of Alkotinib 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
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The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC. The study is a non-control study. The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study. This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.

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

Conditions
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ALK-positive Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Alkotinib Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 At least one measurable lension by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). Willingness and ability to comply with the trial and follow-up procedures. Exclusion Criteria: chemotherapy, radiation therapy, immunotherapy within 4 weeks. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alkotinib 400mg QD<br>400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal. | Drug: Alkotinib Capsules<br>* Alkotinib 400mg QD<br>* Other names: ZG0418;|

What is the study measuring?
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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 |
| --- | --- | --- |
| Progression-free survival (PFS) as assessed by independent radiology review and investigator | PFS, defined as time from first dose of Alkotinib to progression or death due to any cause. | 36 months | 
| Overall survival (OS) | OS, defined as time from first dose of Alkotinib to death due to any cause | 36 months |