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

Launched by BETTA PHARMACEUTICALS CO., LTD. · May 29, 2020

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Female or male, 18 years of age or older
• • 2. Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
• • 3. 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.
• • 4. 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.
• • 5. A Karnofsky Performance Status score of at least 60.
• • 6. An expected survival time of at least 12 weeks.
• • 7. Adequate organ functions.
• • 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.
• • 5. 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.
• • 6. Patients who previously received organ transplantation or stem cell transplantation.
• • 7. Patients with clinically significant cardiovascular diseases.
• • 8. Patients with active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
• • 9. Patients with interstitial lung disease history or signs of active interstitial lung disease.
• • 10. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
• • 11. Pregnant and lactating women.
• • 12. Patients with other illness or medical conditions potentially interfering with the study treatment.