CompletedNot applicableNCT03603002
Official study title

Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer

Study summary

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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedPost-SABR Biopsy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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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