adjuvant therapy of ensartinib in stage ib-iiia alk-positive non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

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.


Eligibility criteria:
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.

Keywords: ensartinib adjuvant therapy alk tyrosine kinase inhibitor