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Not yet recruiting NCT06697990

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

Phase II Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iruplinalib.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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

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

Primary outcome measures

  • Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules [Time frame: 28 days]
Secondary outcome measures (5)
  • Iruplinalib concentration in cerebrospinal fluid [Time frame: Day 28]
  • Objective response rate [Time frame: 16 weeks]
  • Disease control rate [Time frame: 16 weeks]
  • Intracranial objective response rate [Time frame: 16 weeks]
  • Intracranial disease control rate [Time frame: 16 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06697990 · QLMA-NSCLC-IIT-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗