Status:
UNKNOWN
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Collaborating Sponsors:
Fudan University
Conditions:
Lung Cancer, Nonsmall Cell
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
- Female or male, 18 years of age or older
- Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
- 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.
- 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.
- A Karnofsky Performance Status score of at least 60.
- An expected survival time of at least 12 weeks.
- Adequate organ functions.
- Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss.
- Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Signed and dated informed consent.
Exclusion
- Currently under treatment of other systemic anti-cancer therapies.
- Evidence of active malignancy within last 5 years.
- Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
- Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment.
- Patients who need to receive drugs which are potent CYP3A4 inhibitors or inducers within last 2 weeks before the initiation of study treatment and during the study.
- Patients who previously received organ transplantation or stem cell transplantation.
- Patients with clinically significant cardiovascular diseases.
- Patients with active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
- Patients with interstitial lung disease history or signs of active interstitial lung disease.
- Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
- Pregnant and lactating women.
- Patients with other illness or medical conditions potentially interfering with the study treatment.
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04415320
Start Date
March 21 2019
End Date
June 1 2021
Last Update
June 4 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China