Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Ensartinib Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity |
Drug: Ensartinib
Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
Other Names:
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Outcome Measures
Primary Outcome Measures
- 3-year disease free survival rate (DFSR) [3 years]
Defined as the percentage of patients alive and disease free at 3 years
Secondary Outcome Measures
- 5-year overall survival rate [5 years]
Defined as the percentage of patients alive at 5 years
- disease free survival (DFS) [Up to 5 years]
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)
- overall survival (OS) [Up to 5 years]
Defined as the time from starting treatment to death.
- Adverse Events [Up to 3 years]
The safety and tolerability profile of Ensartinib
Eligibility Criteria
Criteria
Inclusion Criteria:
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Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS).
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Males or females aged ≥18 years, ≤75 years.
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ECOG performance status 0-2.
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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).
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Clinical examinations before treatment report no signs of disease recurrance.
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With enough tumor histology specimens (non-cytology) for molecular marker analysis.
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hemoglobin concentration ≥ 100 g/L (permit to maintain hematologic criteria by blood transfusion); absolute neutrophil count (ANC) ≥1.5×109/L; platelet count ≥100×109/L.
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Liver Function: TBil ≤2xULN; ALT and AST ≤2.5xULN;
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Renal Function: Cr ≤1.5xULN, and Ccr ≥60ml/min;
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Signed inform consent form by patient or his/her legal representative.
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Comply with study protocol and procedure, and be able to take oral medication.
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Female patients of childbearing potential must have a negative urine pregnancy test within 7 days before study treatment.
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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:
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Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal antibody) and experimental therapy for NSCLC in the past.
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Having local radiotherapy of NSCLC.
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Known allergy to Ensatinib or any of the ingredients in this product.
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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.
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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.
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Women who are pregnant or breastfeeding.
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Having history of neurological or psychiatric disorders, including epilepsy or dementia.
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Other conditions investigators evaluate that patient is not eligible to this study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Jun Feng Liu | Shijiazhuang | Hebei | China | 050011 |
Sponsors and Collaborators
- Hebei Medical University Fourth Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BD-EN-IV006