CompletedNot applicableNCT03603002

Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer

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.

Checked against the public recordLast updated Jul 2, 2026 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations1
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Interventions being studied
Diagnostic Test: Post-SABR Biopsy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Bayview Medical CenterBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 2, 2026. Always confirm current availability with the study team.

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