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

Launched by HEBEI MEDICAL UNIVERSITY FOURTH HOSPITAL · Feb 6, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a medication called Ensartinib as an additional treatment for patients with stage IB-IIIA non-small cell lung cancer (NSCLC) that has a specific genetic change known as ALK-fusion. The goal is to see how effective and safe Ensartinib is when given after surgery to remove the tumor. Patients participating in the study will take Ensartinib for up to three years or until their cancer comes back or if they experience side effects that are too difficult to manage.

To join the trial, patients must be between 18 and 75 years old, have fully recovered from their cancer surgery, and show no signs of disease recurrence. They also need to provide test results confirming their cancer is ALK-positive and meet certain health criteria. Throughout the study, participants will be closely monitored to ensure their safety and to assess how well the treatment works. This research is important because it could lead to better options for patients with this type of lung cancer.

Gender

ALL

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.