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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iruplinalib | Experimental | The treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iruplinalib | Drug | 60 mg of Iruplinalib, once daily for 7 days, followed by 180 mg of Iruplinalib, once daily in a 28-days cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules | 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). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Iruplinalib concentration in cerebrospinal fluid | Iruplinalib concentration in cerebrospinal fluid. | Day 28 |
| Objective response rate | Objective response rate is defined as the percentage of participants who have a complete response or partial response. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 16 weeks |
| Disease control rate | Disease control rate is defined as the percentage of participants who have a best overall response of complete response, partial response, or stable disease. | 16 weeks |
| Intracranial objective response rate | 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. | 16 weeks |
| Intracranial disease control rate | 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. | 16 weeks |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |