Recruiting
Phase 2

PD-1/PD-L1 Therapy

Sponsor:

CellSight Technologies, Inc.

Code:

NCT06107374

Conditions

Advanced Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]F-AraG

Study Details

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

Study ID

NCT06107374

Start date

Nov 1, 2023

Status verified date

Oct, 2024

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

[18F]F-AraG

Two PET scans

Primary outcome measure

  • [18F]F-AraG Quantification [ Time Frame: One Year ]
  • [18F]F AraG Correlation [ Time Frame: One Year ]

Central Contacts and Locations

Central contacts

Amy Mundisev

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

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52246

Contacts

Amy Mundisev

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

More Information

Sponsor

CellSight Technologies, Inc.

Last update posted

Oct 24, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CellSight Technologies, Inc. on 2024-10-24.