lung cancer NSCLC
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Have a diagnosis of cytologically proven or suspicion on early stage (T1N0-T3N0/Nx) NSCLC, for which SABR has been recommended following discussions within a multi-disciplinary tumor board. 2. Be willing and able to provide written informed consent for the trial. 3. Be 18 years of age on day of signing informed consent.
Exclusion criteria
Exclusion criteria: 1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 30 days prior to the planned SABR. 2. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 30 days prior to SABR. 3. Has 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. 4. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen*s syndrome will not be excluded from the study. 5. Has a history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis. 6. Has an active infection requiring systemic therapy. 7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject*s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 8. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or a known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this study are the immunological responses in the peripheral blood. The endpoints will be assessed by examination of the liquid biopsies and peripheral blood to detect immunomodulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secundary parameters | — |
Countries
Netherlands
Outcome results
None listed