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

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

[18F]F-AraG Injection

About this trial

This is an interventional diagnostic trial for Non-small Cell Lung Cancer (NSCLC) focused on measuring J19119, PET/CT, [18F]F-AraG, NSCLC, PD-1, PD-L1, immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]F-AraG

Arm Description

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

Outcomes

Primary Outcome Measures

Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1

Percent Change in standard uptake value (SUV) of [18F]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy.

Percent pathologic response at the time of surgery

100% minus the percentage of viable tumor remaining in the tumor bed.

Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient

Spearman correlation coefficient will be calculated in assessing the correlation between [18F]F-AraG uptake and pathologic response.

Secondary Outcome Measures

Full Information

NCT ID

NCT04524195

First Posted

August 19, 2020

Last Updated

January 9, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

CellSight Technologies, Inc., Stand Up To Cancer

1. Study Identification

Unique Protocol Identification Number

NCT04524195

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

February 1, 2026 (Anticipated)

Study Completion Date

February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

CellSight Technologies, Inc., Stand Up To Cancer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer (NSCLC)

Keywords

J19119, PET/CT, [18F]F-AraG, NSCLC, PD-1, PD-L1, immunotherapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

[18F]F-AraG

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

[18F]F-AraG Injection

Intervention 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.

Primary Outcome Measure Information:

Title

Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1

Description

Percent Change in standard uptake value (SUV) of [18F]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy.

Time Frame

Baseline and 10-14 days after first dose of neoadjuvant therapy

Title

Percent pathologic response at the time of surgery

Description

100% minus the percentage of viable tumor remaining in the tumor bed.

Time Frame

At the time of surgery

Title

Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient

Description

Spearman correlation coefficient will be calculated in assessing the correlation between [18F]F-AraG uptake and pathologic response.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary K Brosnan, BA

Phone

410-955-8264

mbrosna1@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Rehab AbdAllah, MB BCH

Phone

410-955-6615

rabdall1@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary K Brosnan, BA

Phone

410-955-8264

mbrosna1@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Rehab Abdallah, MB BCh

Phone

410-955-6615

rabdall1@jhmi.edu

First Name & Middle Initial & Last Name & Degree

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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