Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer

Completed · Not applicable

Conditions studied: Non-small Cell Lung Cancer Stage I

In brief

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.

Key facts

Study ID

NCT03603002

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

6

Starts

2018-10-16

Expected to finish

2025-06-27

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Primary tumors not amenable to serial core biopsies.
• 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.
• Female patients who are pregnant from screening to completion of SABR

Where it is running

• Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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