Recruiting PHASE1 Non Small Cell Lung Cancer

New treatment option for Non Small Cell Lung Cancer

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

ClinicalTrials.gov ID: NCT06439914

What this study is testing

What is [89Zr]Zr-DFO-emapalumab?

[89Zr]Zr-DFO-emapalumab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for non small cell lung cancer.

Also referred to as Zirconium Zr 89-DFO-emapalumab.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • must be able to lie still for the tests. Their girth and weight must be suitable to enter the gantry, which varies per tomograph.
See the full eligibility criteria
Who can join
  • 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...
  • Pregnant or breast feeding individuals.

The study team makes the final eligibility decision.

Where it's taking place

  • Detroit, Michigan, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.