PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)

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

Sponsors

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborator: CellSight Technologies, Inc.
Stand Up To Cancer

Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.

Overall Status Not yet recruiting
Start Date February 2021
Completion Date February 1, 2027
Primary Completion Date February 1, 2026
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1 Baseline and 10-14 days after first dose of neoadjuvant therapy
Percent pathologic response at the time of surgery At the time of surgery
Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient 5 years
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: [18F]F-AraG Injection

Description: Single dose of 5 mCi+/- [18F]F-AraG IV injection followed by the PET/CT scan. A baseline [18F]F-AraG PET/CT will be performed at about 0-7 days before patient receives the first dose of PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed at less than 14 days after the first dose of PD-1/PD-L1 immunotherapy is administered and before the second dose of PD-1/PD-L1 immunotherapy is given.

Arm Group Label: [18F]F-AraG

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Martin Pomper, M.D., Ph.D. Principal Investigator Johns Hopkins University
Overall Contact

Last Name: Mary K Brosnan, BA

Phone: 410-955-8264

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: Johns Hopkins University Mary K Brosnan, BA 410-955-8264 [email protected] Martin Pomper, M.D., Ph.D. Principal Investigator
Location Countries

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: [18F]F-AraG

Type: Experimental

Description: A one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov