NCT06439914

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
36mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Jun 2029

First Submitted

Initial submission to the registry

May 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

May 28, 2024

Last Update Submit

March 9, 2026

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • change of SUVpeak

    Up to Day 45

  • change of SUVmean

    Up to Day 45

  • change of SUVmax

    Up to Day 45

Other Outcomes (3)

  • change of SUVpeak by PET response

    Up to Day 45

  • change of SUVmean by PET response

    Up to Day 45

  • change of SUVmax by PET response

    Up to Day 45

Study Arms (1)

[89Zr]Zr-DFO-emapalumab

EXPERIMENTAL

Radiotracer \[89Zr\]Zr-DFO-emapalumab injection

Drug: [89Zr]Zr-DFO-emapalumab

Interventions

[89Zr]Zr-DFO-emapalumabDRUG

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

Also known as: Zirconium Zr 89-DFO-emapalumab
[89Zr]Zr-DFO-emapalumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nerissa T Viola, PhD

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nerissa T Viola, PhD

CONTACT

3135768309violan@karmanos.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 3, 2024

Study Start

March 9, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)