Trial Outcomes & Findings for Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer (NCT NCT03603002)
NCT ID: NCT03603002
Last Updated: 2025-10-14
Results Overview
T-cell receptor (TCR) profile changes in the tumor using TCR sequencing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline to up to 7 days after SABR treatment
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
Stage I NSCLC With SABR Therapy
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.
Post-SABR Biopsy: Post-SABR Biopsy
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|---|---|
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Overall Study
STARTED
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6
|
|
Overall Study
COMPLETED
|
6
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer
Baseline characteristics by cohort
| Measure |
Stage I NSCLC With SABR Therapy
n=6 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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6 Participants
n=5 Participants
|
|
Age, Continuous
|
75 Years
n=5 Participants
|
|
Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 7 days after SABR treatmentPopulation: None of the core-needle samples were able to be analyzed and no data was collected from samples.
T-cell receptor (TCR) profile changes in the tumor using TCR sequencing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-SABRPopulation: None of the core-needle samples were able to be analyzed and no data was collected from samples.
Candidate tumor antigens, mutation associated neo-antigens (MANAs), and tumor associated neo-antigens, (TAAs) released from the tumor by SABR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 to 7 day post SABRPopulation: Scores for each participant is reported.
Semiquantitative immunohistochemistry scoring system was used to evaluate pathological changes, immune-cell populations (CD8, FoxP3), within the tumor. Semiquantitative scoring system: 0 None, 1: 1-5, 2: 6-10, 3: 11-20, 4: 21 or more positive cells per high powered field (400x). Score for each participant is reported.
Outcome measures
| Measure |
Stage I NSCLC With SABR Therapy
n=6 Participants
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.
|
|---|---|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 1, CD8
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0 score on a scale
|
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Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 2, CD8
|
0 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 3, CD8
|
0 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 4, CD8
|
NA score on a scale
No tumor or minimal detected on slide
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 5, CD8
|
NA score on a scale
No tumor or minimal detected on slide
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 6, CD8
|
1 score on a scale
|
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Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 1, FoxP3
|
0 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 2, FoxP3
|
NA score on a scale
No tumor or minimal detected on slide
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 3, FoxP3
|
0 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 4, FoxP3
|
NA score on a scale
No tumor or minimal detected on slide
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 5, FoxP3
|
NA score on a scale
No tumor or minimal detected on slide
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes in the Tumor After SABR.
Participant 6, FoxP3
|
1 score on a scale
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SECONDARY outcome
Timeframe: Within one year after SABRPopulation: Four patients had sufficient paired pre- and post-SABR tumor and blood samples for analysis to identify antigen-specific TCRs in the blood.
Assessed by the Mutation-Associated Neoantigen Functional Expansion of Specific T-cells (MANAFEST) assay. Number of participants where a peripheral neoantigen-specific T-cell responses and dynamics was detected is reported.
Outcome measures
| Measure |
Stage I NSCLC With SABR Therapy
n=4 Participants
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.
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|---|---|
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Detection of Peripheral Neoantigen-specific T-cell Responses and Dynamics After SABR.
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2 Participants
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SECONDARY outcome
Timeframe: 1 yearDual-energy (DE) CT imaging characteristics after SABR. Evaluate relationship between dual-energy (DE) CT imaging characteristics, radiation dose, and early post-SABR pathologic outcomes after treatment with SABR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.Patients with grade 2+ toxicity measured by NCIs Common Terminology Criteria for Adverse Events (CTCAE 4.0), due to post-SABR biopsy.
Outcome measures
| Measure |
Stage I NSCLC With SABR Therapy
n=6 Participants
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.
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|---|---|
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Number of Participants With Grade 2+ Toxicity Events
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0 Participants
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SECONDARY outcome
Timeframe: 5 to 7 day post SABRPopulation: Scores for each participant is reported
Semiquantitative immunohistochemistry scoring system was used to evaluate pathological changes, (CD8, FoxP3, PD-L1/PD-1) expression within the peritumoral stoma after SABR. Semiquantitative scoring system: 0 None, 1: 1-5, 2: 6-10, 3: 11-20, 4: 21 or more positive cells per high powered field (400x). Score for each participant is reported.
Outcome measures
| Measure |
Stage I NSCLC With SABR Therapy
n=6 Participants
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.
|
|---|---|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 1, CD8
|
4 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 2, CD8
|
2 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 3, CD8
|
3 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 4, CD8
|
4 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 5, CD8
|
NA score on a scale
No tumor or minimal detected on slide
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 6, CD8
|
3 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 1, FoxP3
|
3 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 2, FoxP3
|
3 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 3, FoxP3
|
1 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 4, FoxP3
|
3 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 5, FoxP3
|
NA score on a scale
No tumor or minimal detected on slide
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 6, FoxP3
|
3 score on a scale
|
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Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 1, PD1
|
3 score on a scale
|
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Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 2, PD1
|
2 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 3, PD1
|
2 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 4, PD1
|
4 score on a scale
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 5, PD1
|
NA score on a scale
No tumor or minimal detected on slide
|
|
Semiquantitative Scoring System to Describe the Influx of Key Tumor Infiltrating Lymphocytes Within the Peritumoral Stoma After SABR.
Participant 6, PD1
|
3 score on a scale
|
Adverse Events
Stage I NSCLC With SABR Therapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stage I NSCLC With SABR Therapy
n=6 participants at risk
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.
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|---|---|
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Psychiatric disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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Psychiatric disorders
Anorexia
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33.3%
2/6 • Number of events 3 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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Psychiatric disorders
anxiety
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66.7%
4/6 • Number of events 5 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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Infections and infestations
Bronchial Infection
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33.3%
2/6 • Number of events 2 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
|
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Gastrointestinal disorders
Constipation
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50.0%
3/6 • Number of events 3 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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General disorders
Cough
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100.0%
6/6 • Number of events 14 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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General disorders
Difficulty swallowing
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16.7%
1/6 • Number of events 1 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
|
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General disorders
Dizziness
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16.7%
1/6 • Number of events 1 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
6/6 • Number of events 13 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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General disorders
Fatigue
|
100.0%
6/6 • Number of events 10 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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General disorders
Headache
|
50.0%
3/6 • Number of events 4 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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Respiratory, thoracic and mediastinal disorders
Hypoxia
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16.7%
1/6 • Number of events 1 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
|
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General disorders
Pain
|
50.0%
3/6 • Number of events 3 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
|
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Nervous system disorders
Peripheral Sensory Neuropathy
|
100.0%
6/6 • Number of events 7 • Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
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Additional Information
Dr. K. Ranh Voong
Johns Hopkins University, Department of Radiation Oncology
Phone: 410-550-6597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place