Non Small Cell Lung CancerPhase 1NCT06439914
First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
A Phase 1 study testing [89Zr]Zr-DFO-emapalumab in people with Non Small Cell Lung Cancer, run by Nerissa T. Viola at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- [89Zr]Zr-DFO-emapalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Nerissa T Viola, PhD, 3135768309, violan@karmanos.org
Nerissa T Viola, PhD
About this study
Official title: IFN-y PET Imaging: Bench to Bedside
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.
Read the detailed description
Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam.
-Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- [89Zr]Zr-DFO-emapalumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[89Zr]Zr-DFO-emapalumabDrug
Also called Zirconium Zr 89-DFO-emapalumab
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
| Study group | Role | What they receive |
|---|---|---|
| [89Zr]Zr-DFO-emapalumab | Experimental | Radiotracer [89Zr]Zr-DFO-emapalumab injection Receives: Drug: [89Zr]Zr-DFO-emapalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak Standard Uptake Value (SUVpeak)
Descriptively summarize at baseline and post-immunotherapy treatments.
Measured: Up to Day 45
mean Standard Uptake Value (SUVmean)
Descriptively summarize at baseline and post-immunotherapy treatments.
Measured: Up to Day 45
maximum Standard Uptake Value (SUVmax)
Descriptively summarize at baseline and post-immunotherapy treatments.
Measured: Up to Day 45
Secondary outcomes (3)
change of SUVpeak
Descriptively summarize the percent change from baseline to post-immunotherapy treatments.
Measured: Up to Day 45
change of SUVmean
Descriptively summarize the percent change from baseline to post-immunotherapy treatments.
Measured: Up to Day 45
change of SUVmax
Descriptively summarize the percent change from baseline to post-immunotherapy treatments.
Measured: Up to Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start9 Mar 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nerissa T. Viola
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nerissa T. Viola, Barbara Ann Karmanos Cancer Institute
- Investigators
- Nerissa T Viola, PhD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439914
- Sponsor's protocol ID
- 2023-092
- Status last verified
- Mar 2026
- First submitted
- 28 May 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IFN-y PET Imaging: Bench to Bedside
- ClinicalTrials.gov ID
- NCT06439914
- Acronym / sponsor ID
- 2023-092
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Nerissa T. ViolaUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam.
-Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [89Zr]Zr-DFO-emapalumab | Experimental | Drug: [89Zr]Zr-DFO-emapalumabRadiotracer [89Zr]Zr-DFO-emapalumab injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [89Zr]Zr-DFO-emapalumabAlso: Zirconium Zr 89-DFO-emapalumabRadiotracer [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 | Drug | [89Zr]Zr-DFO-emapalumab |
Primary outcome
peak Standard Uptake Value (SUVpeak)
Time frame: Up to Day 45
Descriptively summarize at baseline and post-immunotherapy treatments.
mean Standard Uptake Value (SUVmean)
Time frame: Up to Day 45
Descriptively summarize at baseline and post-immunotherapy treatments.
maximum Standard Uptake Value (SUVmax)
Time frame: Up to Day 45
Descriptively summarize at baseline and post-immunotherapy treatments.
3 secondary outcomes
change of SUVpeak
Time frame: Up to Day 45
change of SUVmean
Time frame: Up to Day 45
change of SUVmax
Time frame: Up to Day 45
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nerissa T Viola, PhD principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [89Zr]Zr-DFO-emapalumab in people with Non Small Cell Lung Cancer, run by Nerissa T. Viola at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nerissa T Viola, PhD (3135768309, violan@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak Standard Uptake Value (SUVpeak) (time frame: Up to Day 45). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.