Immunological effects of stereotactic radiotherapy - An exploratory trial (iDOSE)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

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

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this study are the immunological responses in the<br /><br>peripheral blood. The endpoints will be assessed by examination of the liquid<br /><br>biopsies and peripheral blood to detect immunomodulation. </p><br>

Secondary Outcome Measures