NCT06779539

Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer

A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer：A Prospective, Open-label, Multi-center, Single-arm, Phase II Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-arm, prospective, multicenter, phase II study is designed to evaluate the efficacy and safety of ensartinib as neoadjuvant treatment in ALK positive, resectable for stage II to III non-small cell lung cancer patients.

Detailed description

This is a single-Arm, prospective, multicenter, phase II study, the primary endpoint is pathological complete response (pCR). Participants will receive ensartinib at 225 mg orally once a day taken with or without food for 12 weeks before surgical resection.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ensartinib	Ensartinib 225 mg oral once daily 12 weeks

Timeline

• Start date: 2025-01-15
• Primary completion: 2028-06-12
• Completion: 2030-12-12
• First posted: 2025-01-16
• Last updated: 2025-01-17