drugset / Trial / NCT06772610

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

NCT06772610

Phase 2 Not yet recruiting 40 enrolled Shanghai Pulmonary Hospital, Shanghai, China
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-03-15
Primary completion
2029-03-31
Completion
2032-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ensartinib Small molecule 200 mg Oral