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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iruplinalib

Drug

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

Other names: WX-0593

Primary outcomes

Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules

Time frame: 28 days

Cerebrospinal fluid levels of natural killer (NK) cells,CD3+ T cells,CD4+ T cells,CD8+ T cells,tumour necrosis factor alpha(TNF-α), interleukin-6(IL-6), interferon-gamma(IFN-γ), high C-reactive protein(hs-CRP),immunoglobulin A(IgA),immunoglobulin E(IgE),immunoglobulin G(IgG),immunoglobulin M(IgM),intercellular adhesion molecule 1(ICAM-1) and vascular cell adhesion molecule 1(VCAM-1).

Secondary outcomes

Iruplinalib concentration in cerebrospinal fluid

Time frame: Day 28

Iruplinalib concentration in cerebrospinal fluid.
Objective response rate

Time frame: 16 weeks

Objective response rate is defined as the percentage of participants who have a complete response or partial response.
Disease control rate

Time frame: 16 weeks

Disease control rate is defined as the percentage of participants who have a best overall response of complete response, partial response, or stable disease.
Intracranial objective response rate

Time frame: 16 weeks

Intracranial objective response rate is defined as above for objective Response Rate but it is only based on intracranial disease in the subset of patients with intracranial lesion.
Intracranial disease control rate

Time frame: 16 weeks

Intracranial disease control rate is defined as above for disease control rate but it is only based on intracranial disease in the subset of patients with intracranial lesion.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

Exploring the Mechanism of Cerebrospinal Fluid Immune Microenvironment in Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Lung Cancer With Brain Metastases Treated With Iruplinalib: an Interventional Study

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Nov 20, 2024
Registry last updated: Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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