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

NCT06697990 | Not Yet Recruiting Phase 2

• 1 other identifier: QLMA-NSCLC-IIT-001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (1)

Iruplinalib

EXPERIMENTAL

The treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator.

Drug: Iruplinalib

Interventions

Iruplinalib DRUG

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

Also known as: WX-0593

Iruplinalib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 20, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-08