Non Small Cell Lung Cancer study: [89Zr]Zr-DFO-emapalumab
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?
an investigational radiotracer being studied for imaging response to immunotherapy in 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 study aims to see if the new PET imaging agent can identify cancer spots and show how patients respond to immunotherapy.
- Who it's for
- It is looking for people with non‑small cell lung cancer who have not yet received treatment.
- What's involved
- Participants will receive the imaging agent and have PET scans before starting immunotherapy and again about 30 days later.
- Time commitment
- The study lasts about one month, with two PET scan visits, one before and one after starting treatment.
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Detroit, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.