The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Ensartinib to see how effective and safe it is as a follow-up treatment for patients with stage I ALK-positive non-small cell lung cancer (NSCLC) who are at high risk of their cancer coming back. Participants in this trial will have already had surgery to remove their tumor and will not have received any other treatments afterward. The trial aims to find out if taking Ensartinib for two years after surgery can help prevent cancer recurrence in these patients.

To be eligible for this trial, participants need to be between 18 and 75 years old, have a specific type of lung cancer confirmed by tests, and show certain risk factors that could make their cancer more likely to return, such as poorly differentiated tumors or other signs. They should be in good overall health and able to start treatment within a few weeks after surgery. Participants will be monitored closely during the trial to assess how well the treatment is working and to check for any side effects. It’s important for potential participants to discuss any concerns and ask questions to understand the benefits and risks of joining this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18-75 years;
• • ECOG performance status 0-1;
• • Postoperative histopathology confirms R0 resection with TNM stage I pulmonary adenocarcinoma;
• • Confirmed ALK fusion-positive by FISH, IHC, or NGS;
• • No prior systemic treatment after surgery;
• • At least one high-risk recurrence factor: poorly differentiated tumor, vascular invasion, wedge resection, visceral pleura involvement, uncertain lymph node status, intrapulmonary dissemination;
• • Able to start Ensartinib adjuvant therapy within 4-8 weeks after surgery;
• • Hematological, biochemical, and organ function requirements met: Hemoglobin ≥100 g/L; Absolute neutrophil count ≥1.5×10\^9/L; Platelet count ≥100×10\^9/L; Total bilirubin ≤2 times the upper limit of normal; ALT and AST ≤2.5 times the upper limit of normal; Creatinine ≤1.5 times the upper limit of normal; Creatinine clearance ≥60 mL/min;
• • Women of childbearing potential must have a negative urine pregnancy test - within 7 days prior to starting treatment;
• • Informed consent obtained from the patient or their legal representative;
• • Men and women of childbearing potential must agree to use reliable - contraception from enrollment in the study until 8 weeks after discontinuation of the study drug.
• Exclusion Criteria:
• • Previous systemic treatment for NSCLC;
• • Previous local radiotherapy for NSCLC;
• • Unable to take oral medications;
• • Known allergy to Ensartinib or any component of this product;
• • History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; baseline CT scan showing idiopathic pulmonary fibrosis;
• • Any unstable systemic diseases, including: active infections, uncontrolled hypertension, unstable angina, angina onset within the last 3 months, congestive heart failure (≥ NYHA class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases;
• • Pregnant or breastfeeding women;
• • History of definite neurological or psychiatric disorders, including epilepsy or dementia;
• • Any other conditions that the investigator deems unsuitable for enrollment.