Status:
ACTIVE_NOT_RECRUITING
X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Nonsmall Cell Lung Cancer
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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. Eli...
Eligibility Criteria
Inclusion
- 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
- 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.
- 14\. Patients with other illness or medical conditions potentially interfering with the study treatment.
Key Trial Info
Start Date :
April 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03753685
Start Date
April 12 2019
End Date
June 30 2026
Last Update
July 23 2025
Active Locations (1)
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1
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China, 518100