NCT03603002Completed
Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer
Studying the Pathologic and Immunologic Response After Ablative Radiation in Stage I Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
This is a pilot study to compare pre- and post-SABR core biopsies of stage I NSCLC tumors to identify SABR-induced immune-mediated tumor recognition based on a significant and specific expansion of T-cell clones using a novel T-cell receptor (TCR) sequencing assay. This will be coupled with (1) novel genomic analysis of candidate tumor antigens that may be released from the pre-SABR tumor and (2) functional validation assays to screen post-treatment peripheral blood T-cells for reactivity to these released candidate tumor antigens. In addition, cell-based analysis will be used to identify changes in key T-cell infiltrates into the post-SABR tumor.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 18 Jul 2018
- Start date
- 16 Oct 2018
- Primary completion date
- 1 Sept 2021
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Lung cancer
- NCT number
- NCT03603002
What you commit to
- Study type: Interventional
- Participants enrolled: 6
- From 16 Oct 2018 to the primary completion date, 1 Sept 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior thoracic radiation in the region that will be treated by SABR.
- Patient may not be receiving any other concurrent investigational agents or chemotherapy.
- Patient may not be receiving or received immunotherapy.
- Patients may not be on or use steroids within 14 days before radiation, and from the duration of radiation to the time of the post-SABR biopsies and blood samples.
Other
- Primary tumors not amenable to serial core biopsies.
- Female patients who are pregnant from screening to completion of SABR
Who the study is looking for
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Age \> 18 year
- Confirmed non-small cell lung cancer after initial biopsies
- Patient with accessible tumor for biopsy
- Patient is to have sufficient initial core biopsy samples for tissue analyses
- Stage I lung cancer
- Adequate normal organ and marrow function
- Patient with tumor amenable to SABR treatment as determined by a radiation oncologist
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bayview Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.