Non-small Cell Lung Cancer
Conditions
Keywords
Ensartinib, adjuvant therapy, ALK, Tyrosine kinase inhibitor
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.
Interventions
DRUGEnsartinib
Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate (DFSR) | 3 years | Defined as the percentage of patients alive and disease free at 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 5-year overall survival rate | 5 years | Defined as the percentage of patients alive at 5 years |
| 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 |
Countries
China
Contacts
Primary ContactJunfeng Liu, PhD
Outcome results
None listed