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

Tianjin Medical University

Status and phase

Not yet enrolling

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Iruplinalib

Study type

Interventional

Funder types

Other

Identifiers

NCT06697990

QLMA-NSCLC-IIT-001

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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