Clinical trial · Observational
Association of BAL Fluid T-Cell Immune Activity With Tumor PD-L1 Expression and Its Prognostic Value: A Prospective Observational Study
NCT07331701CI-TRIAL-00100627not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Tumor Immune Microenvironment | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Advanced Lung Cancer Cohort
- description
- Adults with suspected or confirmed stage IV lung cancer undergoing clinically indicated bronchoscopy with bronchoalveolar lavage. Participants are enrolled prospectively as a single observational cohort, and no treatment assignment or intervention is determined by the study. Bronchoalveolar lavage fluid is collected for immune profiling by flow cytometry, and study analyses stratify participants post hoc according to tumor PD-L1 expression levels and bronchoalveolar lavage T-cell immunophenotypes.
Primary outcomes (1)
- measure
- Correlation Between Bronchoalveolar Lavage T-cell Immunophenotypes and Tumor PD-L1 Expression
- timeFrame
- At baseline, prior to initiation of systemic anticancer therapy
- description
- 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%).
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (7)
- RESULTKim IA, Hur JY, Kim HJ, Kim WS, Lee KY. Extracellular Vesicle-Based Bronchoalveolar Lavage Fluid Liquid Biopsy for EGFR Mutation Testing in Advanced Non-Squamous NSCLC. Cancers (Basel). 2022 May 31;14(11):2744. doi: 10.3390/cancers14112744. PMID 35681723
- RESULTKalkanis A, Papadopoulos D, Testelmans D, Kopitopoulou A, Boeykens E, Wauters E. Bronchoalveolar Lavage Fluid-Isolated Biomarkers for the Diagnostic and Prognostic Assessment of Lung Cancer. Diagnostics (Basel). 2022 Nov 25;12(12):2949. doi: 10.3390/diagnostics12122949. PMID 36552956
- RESULTMasuhiro K, Tamiya M, Fujimoto K, Koyama S, Naito Y, Osa A, Hirai T, Suzuki H, Okamoto N, Shiroyama T, Nishino K, Adachi Y, Nii T, Kinugasa-Katayama Y, Kajihara A, Morita T, Imoto S, Uematsu S, Irie T, Okuzaki D, Aoshi T, Takeda Y, Kumagai T, Hirashima T, Kumanogoh A. Bronchoalveolar lavage fluid reveals factors contributing to the efficacy of PD-1 blockade in lung cancer. JCI Insight. 2022 May 9;7(9):e157915. doi: 10.1172/jci.insight.157915. PMID 35389889
- RESULTMariniello A, Tabbo F, Indellicati D, Tesauro M, Rezmives NA, Reale ML, Listi A, Capelletto E, Carnio S, Bertaglia V, Mecca C, Consito L, De Filippis M, Bungaro M, Paratore C, Di Maio M, Passiglia F, Righi L, Sangiolo D, Novello S, Geuna M, Bironzo P. Comparing T Cell Subsets in Broncho-Alveolar Lavage (BAL) and Peripheral Blood in Patients with Advanced Lung Cancer. Cells. 2022 Oct 14;11(20):3226. doi: 10.3390/cells11203226. PMID 36291098
- RESULTMansour MSI, Hejny K, Johansson F, Mufti J, Vidis A, Mager U, Dejmek A, Seidal T, Brunnstrom H. Factors Influencing Concordance of PD-L1 Expression between Biopsies and Cytological Specimens in Non-Small Cell Lung Cancer. Diagnostics (Basel). 2021 Oct 18;11(10):1927. doi: 10.3390/diagnostics11101927. PMID 34679625
- RESULTBen Dori S, Aizic A, Sabo E, Hershkovitz D. Spatial heterogeneity of PD-L1 expression and the risk for misclassification of PD-L1 immunohistochemistry in non-small cell lung cancer. Lung Cancer. 2020 Sep;147:91-98. doi: 10.1016/j.lungcan.2020.07.012. Epub 2020 Jul 13.