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.
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
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
The study population comprises adult patients evaluated at SMG-SNU Boramae Medical Center in Seoul, Republic of Korea. Participants are drawn from routine clinical practice and include patients undergoing clinically indicated bronchoscopy as part of the diagnostic evaluation or management of suspected or confirmed stage IV lung cancer. All clinical assessments, treatments, and follow-up are performed according to standard-of-care practice based on current clinical guidelines, and no additional diagnostic or therapeutic procedures are introduced solely for research purposes.
Cohort
Prospective
Not listed
Correlation Between Bronchoalveolar Lavage T-cell Immunophenotypes and Tumor PD-L1 Expression
The primary outcome is the association between T-cell immunophenotypes quantified in bronchoalveolar lavage fluid by multicolor flow cytometry and tumor PD-L1 expression assessed by immunohistochemistry. T-cell subsets include activated, exhausted, and regulatory T-cell populations defined by surface marker expression (e.g., PD-1, TIM-3, CD39, CD28, CD25, and CD127). Tumor PD-L1 expression is evaluated as the percentage of PD-L1-positive tumor cells and analyzed as a continuous variable and by predefined categories (\<1%, 1-49%, ≥50%).
Differences in Bronchoalveolar Lavage T-cell Immunophenotypes Across Tumor PD-L1 Expression Categories
This outcome compares bronchoalveolar lavage T-cell subset distributions among participants stratified by tumor PD-L1 expression categories (\<1%, 1-49%, and ≥50%). T-cell immunophenotypes are assessed by flow cytometry and include proportions of activated, exhausted, and regulatory T-cell subsets.
Objective Response Rate by Combined Tumor PD-L1 Expression and Bronchoalveolar Lavage T-cell Immunophenotypes
Objective response rate is defined as the proportion of participants achieving complete or partial response according to RECIST version 1.1. Objective response rates are evaluated using combined stratification by tumor PD-L1 expression categories and bronchoalveolar lavage T-cell immunophenotype profiles, and compared with response rates stratified by tumor PD-L1 expression alone to assess improvement in treatment response prediction.
Progression-Free Survival by Combined Tumor PD-L1 Expression and Bronchoalveolar Lavage T-cell Immunophenotypes
Progression-free survival is defined as the time from initiation of systemic anticancer therapy to disease progression or death from any cause, whichever occurs first. Progression-free survival is analyzed using combined stratification based on tumor PD-L1 expression categories (\<1%, 1-49%, ≥50%) and bronchoalveolar lavage T-cell immunophenotype profiles. Survival outcomes using the combined stratification are compared with those based on tumor PD-L1 expression categories alone to evaluate the incremental prognostic value of bronchoalveolar lavage immune profiling.
Overall Survival by Combined Tumor PD-L1 Expression and Bronchoalveolar Lavage T-cell Immunophenotypes
Overall survival is defined as the time from initiation of systemic anticancer therapy to death from any cause. Overall survival is analyzed according to combined stratification by tumor PD-L1 expression categories and bronchoalveolar lavage T-cell immunophenotype profiles. Survival outcomes derived from the combined model are compared with those based on tumor PD-L1 expression alone to assess whether bronchoalveolar lavage immune profiling improves prognostic discrimination.
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Seoul National University Hospital
Lead sponsor
SMG-SNU Boramae Medical Center
Collaborator
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