Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-SABR Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stage I NSCLC with SABR Therapy
- description
- Participants receive stereotactic ablative radiotherapy (SABR) and pre-SABR biopsy as part of standard of care and then receive a post-SABR biopsy after receiving SABR.
- interventionNames
- Diagnostic Test: Post-SABR Biopsy
Primary outcomes (1)
- measure
- Examine the T-cell Receptor Profile Changes Induced in the Tumor After SABR
- timeFrame
- Baseline to up to 7 days after SABR treatment
- description
- T-cell receptor (TCR) profile changes in the tumor using TCR sequencing.
Secondary outcomes (6)
- measure
- Evaluate Candidate Tumor Antigens Released From the Tumor by SABR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available