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X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT03753685•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
•2\. Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy.
•3\. At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared.
•4\. Female or male, 18 years of age or older 5. A Karnofsky Performance Status score of at least 60. 6. An expected survival time of at least 12 weeks. 7. Adequate organ functions, defined as absolute neutrophils count ≥1.5\*10\^9/L，platelets count ≥80\*10\^9/L, hemoglobin concentration≥ 9 g/dL, total bilirubin ≤1.5 \*ULN (upper limits of normal), ALT≤2.5 \*ULN, AST≤2.5 \*ULN, creatinine≤1.5 \*ULN.
•8\. Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss.
•9\. Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
•10\. Signed and dated informed consent.

Exclusion Criteria

•1\. Currently under treatment of other systemic anti-cancer therapies. 2. Evidence of active malignancy within last 5 years. 3. Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
•4\. Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment, or received radiotherapy within last 2 weeks before the initiation of study treatment.
•5\. Patients who previously received organ transplantation or stem cell transplantation.
•6\. Patients with clinically significant cardiovascular and cerebrovascular diseases.
•7\. Patients with dysphagia, active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
•8\. Patients who are active carrier of hepatitis B (HBsAg positive and HBV-DNA ≥500IU/mL), hepatitis C virus antibody, treponema pallidum antibody or HIV antibody.
•9\. Patients with interstitial lung disease history or signs of active interstitial lung disease.
•10\. Pregnant and lactating women. 11. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
•12\. Patients who need to receive drugs which could induce QT/QTc interval prolongation or torsade de pointes, or drugs which are potent CYP3A4 inhibitors or inducers within last 14 days before the initiation of study treatment and during the study.
•13\. Patients who are currently under treatment of warfarin or other coumarin anticoagulants.
+1 more criteria

Locations (1)

Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Key Dates

Start Date

April 12, 2019

Primary Completion Date

June 30, 2025

Completion Date

June 30, 2026

Last Updated

July 23, 2025

Enrollment

ACTUAL participants

Conditions

Nonsmall Cell Lung CancerBrain Metastases

Interventions

X-396(Ensartinib) Capsule

DRUG

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

View study

RECRUITINGPHASE2

Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

NCT04253964

Nonsmall Cell Lung CancerPerformance Status

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

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