Spots Global Cancer Trial Database for X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

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Trial Identification

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

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

Study ID: NCT03753685

Conditions

Nonsmall Cell Lung Cancer

Brain Metastases

Interventions

X-396(Ensartinib) Capsule

Study Description

Brief 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.