First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy

IFN-y PET Imaging: Bench to Bedside

The goal of this clinical trial is to investigate the use of [89Zr]Zr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer (NSCLC) patients. PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: [89Zr]Zr-DFO-emapalumab

Detailed Description

Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam.

-Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans.

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nerissa T Viola, PhD; Phone Number: 3135768309; Email: violan@karmanos.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
      • Sub-Investigator: Hirva Mamdani, M.D.
      • Sub-Investigator: Ammar Sukari, M.D.
      • Sub-Investigator: Dipesh Uprety, M.D.
      • Contact: Nerissa T Viola, PhD; Phone Number: 3135768309; Email: violan@karmanos.org
      • Principal Investigator: Nerissa T Viola, PhD
      • Sub-Investigator: Anthony F Shields, MD, PhD
      • Sub-Investigator: Tarik Hadid, MD, MPH, MS
      • Sub-Investigator: Otto Muzik, PhD
      • Sub-Investigator: Huailei Jiang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion

• Prior histologic or cytologic diagnosis of non-small cell lung cancer.
• FDG PET done within 2 months of the baseline imaging, as part of standard-of-care.
• measurable disease by RECIST 1.1 with at least one lesion of at least 2 cm in a region of the body that can be imaged by PET (e.g.,outside of the liver)
• must be able to lie still for the tests. Their girth and weight must be suitable to enter the gantry, which varies per tomograph.
• must be >18 years old.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center.
• Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days prior to PET imaging

Exclusion

• No prior immunotherapy for current stage of NSCLC (Non Small Cell Lung Cancer). Immunotherapy in neoadjuvant or adjuvant setting and have recurrence at least 12 months following completion of immunotherapy are eligible after discussion with the principle investigator.
• Pregnant or breast feeding individuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [89Zr]Zr-DFO-emapalumab; Radiotracer [89Zr]Zr-DFO-emapalumab injection	Drug: [89Zr]Zr-DFO-emapalumab; Radiotracer [89Zr]Zr-DFO-emapalumab administration followed by 3 PET Scans (day 0, day 1 and day 3-5) within 14 days of starting immunotherapy and repeated once 25-45 days after immunotherapy started; Other Names: Zirconium Zr 89-DFO-emapalumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak Standard Uptake Value (SUVpeak)	Descriptively summarize at baseline and post-immunotherapy treatments.	Up to Day 45
mean Standard Uptake Value (SUVmean)	Descriptively summarize at baseline and post-immunotherapy treatments.	Up to Day 45
maximum Standard Uptake Value (SUVmax)	Descriptively summarize at baseline and post-immunotherapy treatments.	Up to Day 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of SUVpeak	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.	Up to Day 45
change of SUVmean	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.	Up to Day 45
change of SUVmax	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.	Up to Day 45

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of SUVpeak by PET response	Descriptively summarize the percent change from baseline to post-immunotherapy by PET response	Up to Day 45
change of SUVmean by PET response	Descriptively summarize the percent change from baseline to post-immunotherapy by PET response	Up to Day 45
change of SUVmax by PET response	Descriptively summarize the percent change from baseline to post-immunotherapy by PET response	Up to Day 45

Collaborators and Investigators

• Sponsor: Nerissa T. Viola
• Investigators: Principal Investigator: Nerissa T Viola, PhD, Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2023-092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No