Association of BAL Fluid T-Cell Immune Activity With Tumor PD-L1 Expression and Its Prognostic Value: A Prospective Observational Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

This prospective observational study aims to evaluate whether immune profiles of T-cell subsets in bronchoalveolar lavage fluid can complement tumor PD-L1 expression, assessed by immunohistochemistry in tumor tissue specimens, in predicting clinical outcomes in patients with advanced lung cancer. Although tumor PD-L1 expression measured on tissue biopsies is widely used to guide immunotherapy decisions, its predictive value is limited by spatial heterogeneity and sampling variability. By analyzing activated, exhausted, and regulatory T-cell populations in bronchoalveolar lavage fluid and examining their association with tissue-based tumor PD-L1 expression, this study seeks to determine whether combining local immune biomarkers with PD-L1 expression improves the prediction of treatment response and survival in patients receiving standard-of-care systemic therapy.

Eligibility criteria

Qualifiers

Adults aged 19 years or older

Patients with suspected or histologically confirmed stage IV lung cancer based on clinical and radiologic findings

Scheduled to undergo clinically indicated bronchoscopy with bronchoalveolar lavage as part of routine clinical care

Able and willing to provide written informed consent

Disqualifiers

Receipt of treatment for acute lower respiratory tract infection (including pneumonia or fungal infection) within 4 weeks prior to bronchoscopy

History of solid organ transplantation or hematopoietic stem cell transplantation

Current use of systemic immunosuppressive therapy

Current or planned use of biologic immunomodulatory agents

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

60 Participants
are grouped into 1 trial group

Sponsors and collaborators

Seoul National University Hospital

Lead sponsor

SMG-SNU Boramae Medical Center

Collaborator