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

Starting soon

Conditions studied: Lung Neoplasms, Tumor Immune Microenvironment

In brief

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.

Key facts

Study ID

NCT07331701

Run by

Seoul National University Hospital

People needed

60

Starts

2026-01-01

Expected to finish

2027-12-31

Last updated by the study team

2026-01-12

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Known autoimmune disease requiring systemic immunosuppressive treatment
• Pregnant women
• Patients with recurrent stage IV lung cancer after prior definitive therapy

Where it is running

• SMG-SNU Boramae Medical Center — Seoul, Dongjak-gu, South Korea

Full record on ClinicalTrials.gov

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