Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.

Official Title
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Adjuvant Therapy of Ensatinib in Patients With Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer: a Prospective, Multi-center, Single-arm Exploratory Study

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Ensartinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS). Males or females aged ≥18 years, ≤75 years. ECOG performance status 0-2. Completely recovered from surgery or standard postoperative chemotherapy before receiving adjuvant ensatinib treatment. (When starting the study treatment, the patient must have recovered from all toxicities greater than CTCAE Grade 1 caused by the previous treatment, except for hair loss and Grade 2 neuropathy related to previous platinum-based treatments). Clinical examinations before treatment report no signs of disease recurrance. With enough tumor histology specimens (non-cytology) for molecular marker analysis. hemoglobin concentration ≥ 100 g/L (permit to maintain hematologic criteria by blood transfusion); absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L. Liver Function: TBil ≤2xULN; ALT and AST ≤2.5xULN; Renal Function: Cr ≤1.5xULN, and Ccr ≥60ml/min; Signed inform consent form by patient or his/her legal representative. Comply with study protocol and procedure, and be able to take oral medication. Female patients of childbearing potential must have a negative urine pregnancy test within 7 days before study treatment. Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 8 weeks after their last dose of study therapy. Exclusion Criteria: Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal antibody) and experimental therapy for NSCLC in the past. Having local radiotherapy of NSCLC. Known allergy to Ensatinib or any of the ingredients in this product. Previously suffering from interstitial lung disease, drug-induced interstitial disease, radiation pneumonia that requires hormone therapy, or any clinically evidenced active interstitial lung disease; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis. Any unstable systemic disease, including: active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] II Grade), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medical treatment; liver, kidney or metabolic diseases. Women who are pregnant or breastfeeding. Having history of neurological or psychiatric disorders, including epilepsy or dementia. Other conditions investigators evaluate that patient is not eligible to this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Ensartinib<br>Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity | Drug: Ensartinib<br>* Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity<br>* Other names: X-396 capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate (DFSR) | Defined as the percentage of patients alive and disease free at 3 years | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival rate | Defined as the percentage of patients alive at 5 years | 5 years | 
| disease free survival (DFS) | Defined as the time from the date of starting treatment until the date of disease recurrence or death (by any cause in the absence of recurrence) | Up to 5 years | 
| overall survival (OS) | Defined as the time from starting treatment to death. | Up to 5 years | 
| Adverse Events | The safety and tolerability profile of Ensartinib | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ensartinib, adjuvant therapy, ALK, Tyrosine kinase inhibitor