Lung NeoplasmsNCT07331701
Association of BAL Fluid T-Cell Immune Activity With Tumor PD-L1 Expression and Its Prognostic Value: A Prospective Observational Study
An observational study of Lung Neoplasms and Tumor Immune Microenvironment, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Neoplasms, Tumor Immune Microenvironment
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2026to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
SMG-SNU Boramae Medical Center
Seoul, Dongjak-gu, 07061
Deog Kyeom Kim, MD, PhD, +82-2-870-2228, kimdkmd@gmail.com
Heemoon Park, MD, +82-2-870-3439, coramdeo33@gmail.com
About this study
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.
Read the detailed description
Tumor PD-L1 expression assessed by immunohistochemistry on tumor tissue specimens is an established biomarker for selecting immune checkpoint inhibitor therapy in lung cancer; however, its clinical utility is limited by intratumoral heterogeneity, temporal variability, and dependence on the size and location of tissue biopsy samples. As a result, tissue-based PD-L1 expression alone does not fully capture the immune context of the tumor microenvironment or reliably predict treatment response and prognosis in all patients.
Bronchoalveolar lavage fluid provides access to the local pulmonary immune microenvironment and contains immune cells that may reflect tumor-immune interactions more directly than peripheral blood. Prior studies suggest that T-cell populations in bronchoalveolar lavage fluid share phenotypic characteristics with tumor-infiltrating lymphocytes and may serve as surrogate indicators of local antitumor immune activity. However, the relationship between bronchoalveolar lavage T-cell immunophenotypes, tissue-based tumor PD-L1 expression, and clinical outcomes has not been comprehensively evaluated in a prospective setting.
This single-center prospective observational cohort study enrolls adult patients with suspected or confirmed stage IV lung cancer who are undergoing clinically indicated bronchoscopy as part of routine diagnostic or management procedures. Residual bronchoalveolar lavage fluid obtained during standard-of-care bronchoscopy is analyzed using multicolor flow cytometry to quantify T-cell subsets, including activated, exhausted, and regulatory populations defined by surface marker expression. Tumor PD-L1 expression is evaluated by immunohistochemistry performed on diagnostic tumor tissue specimens obtained as part of routine clinical care and analyzed both as a continuous variable and by predefined expression categories.
Participants receive standard systemic anticancer therapy according to current clinical guidelines, including immune checkpoint inhibitor-based regimens when indicated. Clinical outcomes, including objective response rate, progression-free survival, and overall survival, are prospectively collected from electronic medical records. The study examines correlations between bronchoalveolar lavage T-cell immunophenotypes and tissue-based tumor PD-L1 expression, as well as whether stratification based on combined immune profiling provides improved prognostic information compared with tumor PD-L1 expression alone.
By integrating local immune profiling from bronchoalveolar lavage fluid with tumor PD-L1 expression assessed in tissue specimens, this study seeks to identify complementary biomarkers that may enhance risk stratification and refine prognostic assessment in advanced lung cancer, potentially informing future approaches to personalized immunotherapy.
- Conditions
- Lung Neoplasms, Tumor Immune Microenvironment
- Keywords
- Bronchoalveolar Lavage Fluid, Tumor-Infiltrating T Lymphocytes, Programmed Cell Death 1 Ligand 1, Immune Checkpoint Inhibitors, Flow Cytometry, Tumor Immune Microenvironment, Treatment Response, Progression-Free Survival, Overall Survival, Predictive Biomarkers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Lung Cancer Cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: At baseline, prior to initiation of systemic anticancer therapy
Secondary outcomes (4)
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.
Measured: At baseline, prior to initiation of systemic anticancer therapy
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.
Measured: From treatment initiation to first radiologic response assessment (typically 6-12 weeks)
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.
Measured: From treatment initiation to disease progression or death, up to approximately 24 months
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.
Measured: From treatment initiation to death from any cause, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startJan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Deog Kyeom Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331701
- Sponsor's protocol ID
- BRMH 30-2025-48
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. The study includes sensitive clinical, immunologic, and imaging data derived from bronchoalveolar lavage samples and other patient-specific assessments, and no formal data-sharing infrastructure or governance plan has been established at the time of trial registration. However, de-identified individual participant data that underlie the results reported in peer-reviewed publications may be made available after publication upon reasonable request to the corresponding author, subject to appropriate data use agreements, institutional approval, and compliance with applicable ethical and privacy regulations.
Publications
Kim 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.
PubMed 35681723Kalkanis 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.
PubMed 36552956Masuhiro 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.
PubMed 35389889Mariniello 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.
PubMed 36291098Mansour 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.
PubMed 34679625Ben 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.
PubMed 32683207Gniadek TJ, Li QK, Tully E, Chatterjee S, Nimmagadda S, Gabrielson E. Heterogeneous expression of PD-L1 in pulmonary squamous cell carcinoma and adenocarcinoma: implications for assessment by small biopsy. Mod Pathol. 2017 Apr;30(4):530-538. doi: 10.1038/modpathol.2016.213. Epub 2017 Jan 6.
PubMed 28059094
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of BAL Fluid T-Cell Immune Activity With Tumor PD-L1 Expression and Its Prognostic Value: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07331701
- Acronym / sponsor ID
- BRMH 30-2025-48
- Conditions
- Lung Neoplasms, Tumor Immune Microenvironment
- Keywords
- Bronchoalveolar Lavage Fluid, Tumor-Infiltrating T Lymphocytes, Programmed Cell Death 1 Ligand 1, Immune Checkpoint Inhibitors, Flow Cytometry, Tumor Immune Microenvironment, Treatment Response, Progression-Free Survival
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tumor PD-L1 expression assessed by immunohistochemistry on tumor tissue specimens is an established biomarker for selecting immune checkpoint inhibitor therapy in lung cancer; however, its clinical utility is limited by intratumoral heterogeneity, temporal variability, and dependence on the size and location of tissue biopsy samples. As a result, tissue-based PD-L1 expression alone does not fully capture the immune context of the tumor microenvironment or reliably predict treatment response and prognosis in all patients.
Bronchoalveolar lavage fluid provides access to the local pulmonary immune microenvironment and contains immune cells that may reflect tumor-immune interactions more directly than peripheral blood. Prior studies suggest that T-cell populations in bronchoalveolar lavage fluid share phenotypic characteristics with tumor-infiltrating lymphocytes and may serve as surrogate indicators of local antitumor immune activity. However, the relationship between bronchoalveolar lavage T-cell immunophenotypes, tissue-based tumor PD-L1 expression, and clinical outcomes has not been comprehensively evaluated in a prospective setting.
This single-center prospective observational cohort study enrolls adult patients with suspected or confirmed stage IV lung cancer who are undergoing clinically indicated bronchoscopy as part of routine diagnostic or management procedures. Residual bronchoalveolar lavage fluid obtained during standard-of-care bronchoscopy is analyzed using multicolor flow cytometry to quantify T-cell subsets, including activated, exhausted, and regulatory populations defined by surface marker expression. Tumor PD-L1 expression is evaluated by immunohistochemistry performed on diagnostic tumor tissue specimens obtained as part of routine clinical care and analyzed both as a continuous variable and by predefined expression categories.
Participants receive standard systemic anticancer therapy according to current clinical guidelines, including immune checkpoint inhibitor-based regimens when indicated. Clinical outcomes, including objective response rate, progression-free survival, and overall survival, are prospectively collected from electronic medical records. The study examines correlations between bronchoalveolar lavage T-cell immunophenotypes and tissue-based tumor PD-L1 expression, as well as whether stratification based on combined immune profiling provides improved prognostic information compared with tumor PD-L1 expression alone.
By integrating local immune profiling from bronchoalveolar lavage fluid with tumor PD-L1 expression assessed in tissue specimens, this study seeks to identify complementary biomarkers that may enhance risk stratification and refine prognostic assessment in advanced lung cancer, potentially informing future approaches to personalized immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Lung Cancer Cohort | – | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between Bronchoalveolar Lavage T-cell Immunophenotypes and Tumor PD-L1 Expression
Time frame: At baseline, prior to initiation of systemic anticancer therapy
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%).
4 secondary outcomes
Differences in Bronchoalveolar Lavage T-cell Immunophenotypes Across Tumor PD-L1 Expression Categories
Time frame: At baseline, prior to initiation of systemic anticancer therapy
Objective Response Rate by Combined Tumor PD-L1 Expression and Bronchoalveolar Lavage T-cell Immunophenotypes
Time frame: From treatment initiation to first radiologic response assessment (typically 6-12 weeks)
Progression-Free Survival by Combined Tumor PD-L1 Expression and Bronchoalveolar Lavage T-cell Immunophenotypes
Time frame: From treatment initiation to disease progression or death, up to approximately 24 months
Overall Survival by Combined Tumor PD-L1 Expression and Bronchoalveolar Lavage T-cell Immunophenotypes
Time frame: From treatment initiation to death from any cause, up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Results publication: PubMed 35681723Kim 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.
- Results publication: PubMed 36552956Kalkanis 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.
- Results publication: PubMed 35389889Masuhiro 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.
- Results publication: PubMed 36291098Mariniello 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.
- Results publication: PubMed 34679625Mansour 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.
- Results publication: PubMed 32683207Ben 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.
- Results publication: PubMed 28059094Gniadek TJ, Li QK, Tully E, Chatterjee S, Nimmagadda S, Gabrielson E. Heterogeneous expression of PD-L1 in pulmonary squamous cell carcinoma and adenocarcinoma: implications for assessment by small biopsy. Mod Pathol. 2017 Apr;30(4):530-538. doi: 10.1038/modpathol.2016.213. Epub 2017 Jan 6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. The study includes sensitive clinical, immunologic, and imaging data derived from bronchoalveolar lavage samples and other patient-specific assessments, and no formal data-sharing infrastructure or governance plan has been established at the time of trial registration. However, de-identified individual participant data that underlie the results reported in peer-reviewed publications may be made available after publication upon reasonable request to the corresponding author, subject to appropriate data use agreements, institutional approval, and compliance with applicable ethical and privacy regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Tumor Immune Microenvironment, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deog Kyeom Kim, MD, PhD (+82-2-870-2228, kimdkmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Bronchoalveolar Lavage T-cell Immunophenotypes and Tumor PD-L1 Expression (time frame: At baseline, prior to initiation of systemic anticancer therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07331701, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.