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
Overview
- Phase
- Phase 2
- Intervention
- Iruplinalib
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 12
- Primary Endpoint
- Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Iruplinalib
The treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator.
Intervention: Iruplinalib
Outcomes
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(Day 28)
- Objective response rate(16 weeks)
- Disease control rate(16 weeks)
- Intracranial objective response rate(16 weeks)
- Intracranial disease control rate(16 weeks)