Non-small Cell Lung Cancer
Conditions
Brief summary
This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single \[18F\]F-AraG PET exam as part of this study. \[18F\]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of \[18F\]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.
Detailed description
This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single \[18F\]F-AraG PET exam as part of this study. \[18F\]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of \[18F\]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses. A total of 20 patients will be enrolled over an accrual period of approximately 12 months. Approximately 10 patients will be enrolled in the immunotherapy alone cohort and approximately 10 patients will be enrolled in the immunotherapy and stereotactic radiation therapy cohort. Patients will be evaluated one day and one week via telephone after each radiopharmaceutical injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.
Interventions
DRUG[18F]F-Ara-G
Administered after two cycles of immunotherapy +/- stereotactic radiation therapy as part of the PET/CT scan.
DRUGPembrolizumab
All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.
RADIATIONPET/CT scan
Scan will be done after two cycles of immunotherapy +/- stereotactic radiation therapy.
Sponsors
CellSight Technologies, Inc.
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years 2. Histologically or cytologically documented stage I-IIIA non-small cell lung cancer (NSCLC) 3. Eligible for with plan to undergo immunotherapy alone or both immunotherapy and stereotactic radiation therapy as part of NCT03217071 4. In female patients, negative pregnancy test with no plans to become pregnant during the duration of the study 5. Able to provide informed consent and follow the study guidelines
Exclusion criteria
1\. Female patients who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The correlation between number of infiltrating CD3+ T cells/μm2 in the non-small cell lunger cancer thoracotomy specimen as quantified by immunohistochemistry and the activated T-cell concentration as determined by [18F]F-AraG PET (SUVmax) | Baseline (after two cycles of pembrolizumab) | The correlation between number of infiltrating CD3+ T cells/μm2 in the non-small cell lunger cancer thoracotomy specimen as quantified by immunohistochemistry and the activated T-cell concentration as determined by \[18F\]F-AraG PET (SUVmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET | Baseline (after two cycles of pembrolizumab) | The detection of out-of-target radiation-mediated immune modulation in lymph nodes using \[18F\]F-AraG PET |
Outcome results
None listed