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Monoclonal Antibodies

Imaging Agent for Non-Small Cell Lung Cancer

Phase 1
Recruiting
Led By Nerissa T Viola, PhD
Research Sponsored by Nerissa T. Viola
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior histologic or cytologic diagnosis of non-small cell lung cancer
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 45
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study a new imaging agent called [89Zr]Zr-DFO-emapalumab to see if it can help detect lesions and assess how patients with non-small cell

Who is the study for?
This trial is for individuals with non-small cell lung cancer who haven't started treatment. They'll undergo PET scans using a new imaging agent before and after beginning immunotherapy to see how their tumors respond.
What is being tested?
[89Zr]Zr-DFO-emapalumab, an experimental imaging agent, is being tested to visualize the immune response in lung cancer patients using PET scans before and about 30 days following the start of immunotherapy.
What are the potential side effects?
As this is a first-in-human study primarily focused on imaging rather than direct treatment, specific side effects are not detailed but may include reactions related to the PET scan procedure or the imaging agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with non-small cell lung cancer.
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I have a tumor larger than 2 cm that can be seen on a PET scan.
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I am over 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 45
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 45 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
maximum Standard Uptake Value (SUVmax)
mean Standard Uptake Value (SUVmean)
peak Standard Uptake Value (SUVpeak)
Secondary study objectives
change of SUVmax
change of SUVmean
change of SUVpeak
Other study objectives
change of SUVmax by PET response
change of SUVmean by PET response
change of SUVpeak by PET response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: [89Zr]Zr-DFO-emapalumabExperimental Treatment1 Intervention
Radiotracer \[89Zr\]Zr-DFO-emapalumab injection

Find a Location

Who is running the clinical trial?

Nerissa T. ViolaLead Sponsor
Nerissa T Viola, PhDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute
~4 spots leftby Jun 2026
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