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

NCT04415320 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-06-04

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)

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

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2020-12-31
Completion
2021-06-30

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 NCT04415320 on ClinicalTrials.gov