Ignite Creation Date:
2025-12-18 @ 8:35 AM
Ignite Modification Date:
2025-12-18 @ 8:35 AM
Study NCT ID:
NCT03753685
Status:
None
Last Update Posted:
2025-07-23 00:00:00
First Post:
2018-11-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
Sponsor:
None
Organization:
Study Overview
Official Title:
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:
None
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: