NCT03753685

X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

Efficacy and Safety of X-396(Ensartinib) in ALK-Positive NSCLC Patients With Brain Metastases: A Phase Ⅱ, Open-Label, Single Arm, Multicenter Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.

Detailed description

In this phase Ⅱ, open-label, single arm, multicenter study, efficacy and safety of oral X-396 capsule (Ensartinib) in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed. Eligible patients will receive 225mg X-396 capsules once daily and objective responses of brain metastasis based on investigator assessment according to Response Assessment in Neuro-Oncology (RANO) are primary outcome measures.

Conditions

• Nonsmall Cell Lung Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	X-396(Ensartinib) Capsule	All consented, enrolled, eligible patients receive X-396 capsules, 225mg once daily.

Timeline

• Start date: 2019-04-12
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2018-11-27
• Last updated: 2025-07-23

Locations

1 site across 1 country: China