Cerebrospinal Fluid Immune Microenvironment Mechanism in Anaplastic Lymphoma Kinase Positive Lung Cancer Patients

NCT ID: NCT06697990

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-03-31

Brief Summary

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This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases treated with Iruplinalib.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iruplinalib

The treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator.

Group Type EXPERIMENTAL

Iruplinalib

Intervention Type DRUG

60 mg of Iruplinalib, once daily for 7 days, followed by 180 mg of Iruplinalib, once daily in a 28-days cycle.

Interventions

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Iruplinalib

60 mg of Iruplinalib, once daily for 7 days, followed by 180 mg of Iruplinalib, once daily in a 28-days cycle.

Intervention Type DRUG

Other Intervention Names

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WX-0593

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer(NSCLC) that is anaplastic lymphoma kinase (ALK)-postive as assessed by the next-generation sequencing (NGS) test.
* Confirmed diagnosis of brain metastases or suspected brain metastases
* Iruplinalib is proposed for treatment
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
* Adequate organ and marrow function

Exclusion Criteria

* Have serious gastrointestinal disease or other uncontrolled internal diseases and infections
* The presence of mental illness or substance abuse at the time of screening that may have affected compliance with the trial
* The presence of pleural fluid or ascites that requires treatment or is judged by the investigator to be uncontrollable at the time of screening
* Arterial/venous thrombosis events occurred within 6 months prior to administration, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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QLMA-NSCLC-IIT-001

Identifier Type: -

Identifier Source: org_study_id

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