First-in-human Interferon-γ PET imaging to monitor immunotherapy response

IFN-y PET Imaging: Bench to Bedside

This study will try a new PET imaging tracer ([89Zr]Zr-DFO-emapalumab) to detect tumors and early responses to immunotherapy in people with newly diagnosed non-small cell lung cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Barbara Ann Karmanos Cancer Institute (Academic / other)
• Drugs / interventions: immunotherapy, emapalumab
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT06439914 on ClinicalTrials.gov

What this trial studies

This first-in-human trial uses an interferon-γ–targeted PET tracer ([89Zr]Zr-DFO-emapalumab) to image lesions and changes after starting standard-of-care immunotherapy in treatment-naïve NSCLC patients. Participants undergo baseline imaging and a repeat imaging session about 25–45 days after treatment begins, with each injection followed by PET scans at 1–2 hours, the next day, and 3–5 days to capture tracer kinetics. Screening includes standard blood tests, medical history, physical exam, and recent FDG PET; eligible patients must have measurable disease (≥2 cm) and meet lab and body size limits for the scanner. All imaging is done at the sponsoring cancer center with two tracer injections and up to six PET scans per participant.

Who should consider this trial

Good fit: Adults with confirmed non-small cell lung cancer who are treatment-naïve to immunotherapy for their current stage, have measurable lesions of at least 2 cm, can meet required labs and FDG PET timing, and can fit in the PET scanner are ideal candidates.

Not a fit: Patients who already received immunotherapy for their current stage, have only small or non-PET-accessible lesions, or cannot undergo repeated PET scans or meet scanner size/weight limits are unlikely to benefit.

Why it matters

Potential benefit: If successful, this imaging method could help show whether immunotherapy is working earlier and more specifically than current scans.

How similar studies have performed: This is a novel, first-in-human use of IFN-γ PET with [89Zr]Zr-DFO-emapalumab, while immune-targeted PET imaging is an emerging area with limited prior clinical success data.

Eligibility criteria

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.

Where this trial is running

Detroit, Michigan

• Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Nerissa T Viola, PhD — Barbara Ann Karmanos Cancer Institute
• Study coordinator: Nerissa T Viola, PhD

Conditions Non Small Cell Lung Cancer