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NOT YET RECRUITING
NCT06772610
PHASE2

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

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-03-15

Completion Date

2032-03-31

Last Updated

2025-01-13

Healthy Volunteers

No

Interventions

DRUG

Ensartinib group

Ensartinib 200 mg, once daily, orally, for a continuous period of 2 years.