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;