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

NCT03753685 | Active Not Recruiting Phase 2

• 1 other identifier: BTP-42324-IIT
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 outcome measures.

Conditions

Nonsmall Cell Lung Cancer; Brain Metastases

Keywords

NSCLC; Brain metastases; ALK mutations; X-396 (Ensartinib)

Outcome Measures

Primary Outcomes (1)

• Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM.

  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.

  12 weeks

Secondary Outcomes (16)

• Disease control rate based on intracranial response (iDCR) according to RANO-BM.

  12 weeks

• Progression-free survival based on intracranial response (iPFS) according to RANO-BM

  36 months

• Time to progression based on intracranial response (iTTP) according to RANO-BM.

  36 months

• Duration of response based on intracranial response (iDOR) according to RANO-BM.

  36 months

• Intracranial objective response rate (iORR) based on intracranial response according to RECIST 1.1

  12 weeks

Study Arms (1)

X-396(Ensartinib) Capsule

EXPERIMENTAL

Drug: X-396(Ensartinib) Capsule

Interventions

X-396(Ensartinib) Capsule DRUG

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

X-396(Ensartinib) Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. Patients who previously received organ transplantation or stem cell transplantation.
• \. Patients with clinically significant cardiovascular and cerebrovascular diseases.
• \. Patients with dysphagia, active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
• \. 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.
• \. Patients with interstitial lung disease history or signs of active interstitial lung disease.
• \. Pregnant and lactating women. 11. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
• \. 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.
• \. Patients who are currently under treatment of warfarin or other coumarin anticoagulants.
• \. Patients with other illness or medical conditions potentially interfering with the study treatment.

Sponsors & Collaborators

• Fudan University: lead
• Betta Pharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, 518100, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Capsules

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 27, 2018
• Study Start: April 12, 2019
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)