This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. The study population includes patients with ALK-positive NSCLC who have undergone R0 resection and have not received any postoperative treatment, with a TNM stage of I and high-risk factors for recurrence.
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;
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;
Single group
Ensartinib group
DrugEnsartinib 200 mg, once daily, orally, for a continuous period of 2 years.
2 year disease-free survival rate
2-year DFS rate refers to the percentage of patients who remain free of any signs or symptoms of the disease (in this case, cancer) for two years after receiving treatment.
5 year overall survival rate.
The 5 year overall survival rate (5-year OS) is a critical measure in clinical oncology, indicating the percentage of patients who are still alive five years after being diagnosed with cancer or starting treatment.
Disease-free survival
Disease-free survival (DFS) is a measure used in clinical oncology to describe the length of time after treatment during which a patient remains free from any signs or symptoms of the disease.
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