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

NCT ID: NCT04524195

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-11-27

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[18F]F-AraG

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

Group Type: EXPERIMENTAL

[18F]F-AraG Injection

Intervention Type: DRUG

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.

Interventions

[18F]F-AraG Injection

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CellSight Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

Stand Up To Cancer

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Pomper, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00208724

Identifier Type: OTHER

Identifier Source: secondary_id

J19119

Identifier Type: -

Identifier Source: org_study_id