Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer

NCT03603002 | Completed Results FDA Device

• 2 other identifiers: J1826IRB00163415
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer Stage I

Outcome Measures

Primary Outcomes (1)

• Examine the T-cell Receptor Profile Changes Induced in the Tumor After SABR

  T-cell receptor (TCR) profile changes in the tumor using TCR sequencing.

  Baseline to up to 7 days after SABR treatment

Secondary Outcomes (6)

• Evaluate Candidate Tumor Antigens Released From the Tumor by SABR

  post-SABR

• Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.

  5 to 7 day post SABR

• Detection of Peripheral Neoantigen-specific T-cell Responses and Dynamics After SABR.

  Within one year after SABR

• Dual-energy (DE) CT Imaging Characteristics After SABR

  1 year

• Number of Participants With Grade 2+ Toxicity Events

  Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.

Study Arms (1)

Stage I NSCLC with SABR Therapy

EXPERIMENTAL

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.

Diagnostic Test: Post-SABR Biopsy

Interventions

Post-SABR Biopsy DIAGNOSTIC_TEST

Post-SABR Biopsy

Stage I NSCLC with SABR Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. K. Ranh Voong
• Organization: Johns Hopkins University, Department of Radiation Oncology

kvoong1@jhmi.edu

410-550-6597

Study Officials

• Khinh Ranh Voong, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 27, 2018
• Study Start: October 16, 2018
• Primary Completion: September 1, 2021
• Study Completion: June 27, 2025
• Last Updated: October 14, 2025
• Results First Posted: April 26, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)