Study to Investigate the Efficacy and Safety of WX-0593 in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 in patients with ALK-positive NSCLC

Official Title
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A Phase II Study to Investigate the Efficacy and Safety of WX-0593 in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: WX-0593


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: ≥18 years Female or male Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Life expectancy of at least 12 weeks At least one measurable lesion Histologically or cytologically confirmed diagnosis of advanced or recurrent or metastatic NSCLC that is ALK-positive by grade A tertiary hospitals, and subjects should have disease progression (RECIST 1.1) or intolerance (stopping criteria according to drug insert) after 1 or 2 marketed ALK inhibitors, the patients had disease progression after ALK inhibitor should continuously have drug at least 12 weeks , and less than 3 chemotherapy regimens previously No brain metastasis, or asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of > 10 mg/day or equivalent hormone) for more than 2 weeks Key Exclusion Criteria: Crizotinib is the only ALK inhibitor subjects received;unmarketed ALK inhibitor received; Lorlatinib or Brigatinib received; active ingredient or generic drug of ALK inhibitors received HBsAg-positive and/or HBcAb positive and HBV DNA > 1000 copies/mL, or HCV antibody-positive, or known HIV infected

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: WX0593<br>60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 21-days cycle. | Drug: WX-0593<br>* WX-0593 Tablets 60 mg QD，once daily for 7 days, followed by 180 mg of WX-0593 tablets,once daily in a 21-days cycle.<br>* Other names: FL-006;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) Assessed By independent radiology review | ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per independent radiology review using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. | From first administration to the date that the last patients observed for 18 weeks |