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

NCT03753685 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-07-23

No results posted yet for this study

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

Interventions

DRUG

X-396(Ensartinib) Capsule

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

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03753685 on ClinicalTrials.gov