Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG

NCT06107374 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CST-FARAG-IO-UIOW-201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study uses \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in \[18F\]F AraG PET signal before and while on CkIT therapy and to correlate this change in \[18F\]F AraG PET signal with radiographic response. To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment \[18F\]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.

Conditions

Advanced Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• [18F]F-AraG Quantification

  Quantitative assessment of tracer uptake by Standardized Uptake Value (SUV) based measurements within volumes of interest on pre- and on-treatment \[18F\]F AraG PET scans compared.

  One Year

• [18F]F AraG Correlation

  Comparison of quantitative change in tracer uptake between pre- and on-treatment with radiographic outcomes as defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) \> 4 months.

  One Year

Study Arms (1)

Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy

EXPERIMENTAL

Drug: [18F]F-AraG

Interventions

[18F]F-AraG DRUG

Two PET scans

Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.
• Measurable disease.
• ECOG performance status of 0, 1 or 2.
• Subjects are willing to be followed at the University of Iowa.

You may not qualify if:

• Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
• Pregnant women or nursing mothers.
• Patients with severe claustrophobia.

Sponsors & Collaborators

• CellSight Technologies, Inc.: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52246, United States

RECRUITING

Study Officials

• Muhammad Furqan, M.D.

  Holden Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Mundisev

CONTACT

319-356-1445; amy-mundisev@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

US (1)