Non-small Cell Lung Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | February 2029 |
Est. primary completion date | February 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Jun Feng Liu | Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Hebei Medical University Fourth Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year disease free survival rate (DFSR) | Defined as the percentage of patients alive and disease free at 3 years | 3 years | |
Secondary | 5-year overall survival rate | Defined as the percentage of patients alive at 5 years | 5 years | |
Secondary | 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 | |
Secondary | overall survival (OS) | Defined as the time from starting treatment to death. | Up to 5 years | |
Secondary | Adverse Events | The safety and tolerability profile of Ensartinib | Up to 3 years |
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