NCT05241028

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

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

Timeline

• Start date: 2022-05-01
• Primary completion: 2027-02-01
• Completion: 2029-02-01
• First posted: 2022-02-15
• Last updated: 2023-10-10

Locations

1 site across 1 country: China