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Ensartinib

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All consented, enrolled, eligible patients receive X-396 capsules, 225mg once daily.

X-396(Ensartinib) Capsule

Jue Feng

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.

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.

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

iORR per RANO-BM calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.

Defined as the percentage of patients who have achieved intracranial overall response of CR, PR and stable disease (SD), assessed by investigator.

Defined as time from first dose of X-396 capsule to intracranial disease progression or death due to any causes, assessed by investigator.

Defined as time from first dose of X-396 capsule to intracranial disease progression, assessed by investigator.

Defined as time from documentation of intracranial response (CR or PR) to intracranial disease progression or death, assessed by investigator.

iORR per RECIST 1.1 calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.

ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.

Defined as the percentage of patients who have achieved overall response of CR, PR and stable disease (SD), assessed by investigator.

Defined as time from first dose of X-396 capsule to overall disease progression or death due to any causes, assessed by investigator.

Defined as time from first dose of X-396 capsule to overall disease progression, assessed by investigator.

Defined as time from documentation of overall response (CR or PR) to overall disease progression or death, assessed by investigator.

Defined as time from first dose of X-396 to death due to any causes.

Incidence of adverse events occurred during the study (from the timeoint of signing a informed consent form to 30days after the end of trial).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases	NCT03753685	Nonsmall Cell L... Brain Metastase...	X-396(Ensartini...	18 Years -	Fudan University
X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases	NCT03753685	Nonsmall Cell L... Brain Metastase...	X-396(Ensartini...	18 Years -	Fudan University

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