Clinical trial NCT04524195: PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)
Official title: A Study of PET Imaging of T-cell Activation With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-directed Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: J19119
PET/CT
[18F]F-AraG
NSCLC
PD-1
PD-L1
immunotherapy
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: CellSight Technologies, Inc.
name: Stand Up To Cancer
First posted: 2020-08-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called \[18F\]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).

Detailed description: The purpose of this study is to find out how the radiotracer called \[18F\]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. \[18F\]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent.

Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits.

A baseline \[18F\]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second \[18F\]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older and willing and able to provide informed consent.
* Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment.
* For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study.

Exclusion Criteria:

* Severe impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73 m2 and/or on dialysis.
* Pregnant female patients; breastfeeding female patients.
* Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
* Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
* Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.

Primary outcomes:
measure: Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1
timeFrame: Baseline and 10-14 days after first dose of neoadjuvant therapy
measure: Percent pathologic response at the time of surgery
timeFrame: At the time of surgery
measure: Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Martin Pomper, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: