Carcinoma, Non-Small-Cell Lung
Conditions
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.
Interventions
DRUGIruplinalib
60 mg of Iruplinalib, once daily for 7 days, followed by 180 mg of Iruplinalib, once daily in a 28-days cycle.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules | 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
| Measure | Time frame | Description |
|---|---|---|
| Iruplinalib concentration in cerebrospinal fluid | Day 28 | Iruplinalib concentration in cerebrospinal fluid. |
| Objective response rate | 16 weeks | Objective response rate is defined as the percentage of participants who have a complete response or partial response. |
| Disease control rate | 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 | 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 | 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. |
Outcome results
None listed