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RECRUITING
NCT05241028
PHASE2

Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

Sponsor: Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.

Official title: Adjuvant Therapy of Ensatinib in Patients With Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer: a Prospective, Multi-center, Single-arm Exploratory Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2022-05-01

Completion Date

2029-02

Last Updated

2023-10-10

Healthy Volunteers

No

Interventions

DRUG

Ensartinib

Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity

Locations (1)

Jun Feng Liu

Shijiazhuang, Hebei, China