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

NCT04524195 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: J19119IRB00208724
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and 10-14 days after 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.

  At the time of surgery

• 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.

  5 years

Study Arms (1)

[18F]F-AraG

EXPERIMENTAL

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

Drug: [18F]F-AraG Injection

Interventions

[18F]F-AraG Injection 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.

[18F]F-AraG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• CellSight Technologies, Inc.: collaborator
• Stand Up To Cancer: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martin Pomper, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: February 1, 2021
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)