drugset / Trial / NCT05241028

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

NCT05241028

Phase 2 Recruiting 80 enrolled Hebei Medical University Fourth Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-05-01
Primary completion
2027-02
Completion
2029-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ensartinib Small molecule 225 mg Oral