lung cancer pulmonary malignancy
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Be willing and able to provide written informed consent for the study. * Be 18 years of age or older on the day of signing informed consent. * A (suspected) diagnosis of NSCLC. * For the exploration and validation part TNM stage cTxN1-2Mx. * For the qualification part TNM stage cT1-2aN0M0 and planned for SABR treatment. * At least one lymph node with a minimal short axis diameter of 10 mm. * Eligible to undergo an EBUS procedure according to the treating physician and international guidelines. * Able to undergo an EBUS procedure according to institutional guidelines.
Exclusion criteria
Exclusion criteria: * Active infection requiring systemic therapy. * A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * A known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Major surgery or blood transfusions in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the exploration part: difference in the percentage and ratio of immune cells between tumor draining lymph nodes (TDLNs), non-tumor draining lymph nodes (NTDLNs), bronchial wash and peripheral blood. For the qualification part: change in the percentage, activation status and ratio of selected immune cells in TDLNs and NTDLNs after SABR treatment as compared to baseline. | — |
Countries
Netherlands
Outcome results
None listed