Clinical trial · Interventional
Cerebrospinal Fluid Immune Microenvironment Mechanism in Anaplastic Lymphoma Kinase Positive Lung Cancer Patients
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
NCT06697990CI-TRIAL-00082804unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iruplinalib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Iruplinalib
- description
- The treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator.
- interventionNames
- Drug: Iruplinalib
Primary outcomes (1)
- measure
- Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules
- timeFrame
- 28 days
- description
- 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 (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.