Advanced Non Small Cell Lung CancerPhase 2NCT06107374
Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG
A Phase 2 study testing [18F]F-AraG in people with Advanced Non Small Cell Lung Cancer, run by CellSight Technologies, Inc. at 1 site in United States.
Trial summary
This pilot study uses [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in [18F]F AraG PET signal before and while on CkIT therapy and to correlate this change in [18F]F… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non Small Cell Lung Cancer
- What is being tested?
- [18F]F-AraG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Mar 2026
- Phase
- Phase 2
- 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
- Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.
- Measurable disease.
- ECOG performance status of 0, 1 or 2.
- Subjects are willing to be followed at the University of Iowa.
Who cannot join
- Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
- Pregnant women or nursing mothers.
- Patients with severe claustrophobia.
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
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52246
Amy Mundisev, 319-356-1445, amy-mundisev@uiowa.edu
About this study
Official title: Imaging of T-cell Activation With [18F]F-araG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy
This pilot study uses [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in [18F]F AraG PET signal before and while on CkIT therapy and to correlate this change in [18F]F AraG PET signal with radiographic response.
To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment [18F]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.
Read the detailed description
Checkpoint inhibitor therapy has led to impressive clinical successes, providing objective and durable responses in patients with advanced cancers that previously had few treatment options. Unfortunately, immunotherapy works only in a relatively small fraction of patients with solid tumors.
The current standard of care anatomic imaging adequately assessed treatment efficacy in the pre-immunotherapy era, when tumor volume burden directly correlated with clinical outcomes. However, anatomic imaging is found to be limited due to the cellular and molecular nature of early responses to immunotherapy. PET imaging is a sensitive technique that uses radiolabeled agents to visualize the distribution of specific molecular targets in the body. Based on its ability to pinpoint molecular activity, PET imaging agents that target key players of the immune response could offer a powerful noninvasive tool for evaluating complex immunologic processes within the body.
[18F]F-AraG was developed as an agent for imaging activated T cells. [18F]F-AraG is an 18F-labeled analog of 9-b-D-Arabinofuranosylguanine a compound that has shown selective accumulation in T cells and whose prodrug, nelarabine, is FDA-approved for the treatment of patients with T cell acute lymphoblastic leukemia and T cell lymphoblastic lymphoma. [18F]F-AraG is independent of the type of immunotherapy regimen being administered adoptive cell therapy, checkpoint inhibitors, cancer vaccines or a combination of immunotherapy and conventional medicines. In vivo, real-time imaging of activated T cells in solid tumors before and at a timepoint during and after CkIT therapy can help understand the effects of checkpoint blockade therapy. Additionally, in vivo whole-body imaging of activated T cells can provide critical information about the effect of immunomodulation in resulting in autoimmunity, and thus help predict adverse events of immunotherapy.
To sum up, characterizing the immune system alterations in vivo, in real-time, and non-invasively using PET imaging may enable us to predict better which patients will benefit from which Checkpoint Inhibitor Therapy (CkIT) treatment regimen.
- Conditions
- Advanced Non Small Cell Lung Cancer
- Being tested
- [18F]F-AraG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]F-AraGDrug
Two PET scans
| Study group | Role | What they receive |
|---|---|---|
| Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy | Experimental | Not described Receives: Drug: [18F]F-AraG |
What is being measured
The primary outcome is the main question the study is designed to answer.
[18F]F-AraG Quantification
Quantitative assessment of tracer uptake by Standardized Uptake Value (SUV) based measurements within volumes of interest on pre- and on-treatment [18F]F AraG PET scans compared.
Measured: One Year
[18F]F AraG Correlation
Comparison of quantitative change in tracer uptake between pre- and on-treatment with radiographic outcomes as defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) > 4 months.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellSight Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muhammad Furqan, M.D., Principal investigator, Holden Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107374
- Sponsor's protocol ID
- CST-FARAG-IO-UIOW-201
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2023
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of T-cell Activation With [18F]F-araG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy
- ClinicalTrials.gov ID
- NCT06107374
- Acronym / sponsor ID
- CST-FARAG-IO-UIOW-201
- Conditions
- Advanced Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CellSight Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 30 Oct 2023 (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.
This pilot study uses [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in [18F]F AraG PET signal before and while on CkIT therapy and to correlate this change in [18F]F AraG PET signal with radiographic response.
To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment [18F]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.
Detailed description
Checkpoint inhibitor therapy has led to impressive clinical successes, providing objective and durable responses in patients with advanced cancers that previously had few treatment options. Unfortunately, immunotherapy works only in a relatively small fraction of patients with solid tumors.
The current standard of care anatomic imaging adequately assessed treatment efficacy in the pre-immunotherapy era, when tumor volume burden directly correlated with clinical outcomes. However, anatomic imaging is found to be limited due to the cellular and molecular nature of early responses to immunotherapy. PET imaging is a sensitive technique that uses radiolabeled agents to visualize the distribution of specific molecular targets in the body. Based on its ability to pinpoint molecular activity, PET imaging agents that target key players of the immune response could offer a powerful noninvasive tool for evaluating complex immunologic processes within the body.
[18F]F-AraG was developed as an agent for imaging activated T cells. [18F]F-AraG is an 18F-labeled analog of 9-b-D-Arabinofuranosylguanine a compound that has shown selective accumulation in T cells and whose prodrug, nelarabine, is FDA-approved for the treatment of patients with T cell acute lymphoblastic leukemia and T cell lymphoblastic lymphoma. [18F]F-AraG is independent of the type of immunotherapy regimen being administered adoptive cell therapy, checkpoint inhibitors, cancer vaccines or a combination of immunotherapy and conventional medicines. In vivo, real-time imaging of activated T cells in solid tumors before and at a timepoint during and after CkIT therapy can help understand the effects of checkpoint blockade therapy. Additionally, in vivo whole-body imaging of activated T cells can provide critical information about the effect of immunomodulation in resulting in autoimmunity, and thus help predict adverse events of immunotherapy.
To sum up, characterizing the immune system alterations in vivo, in real-time, and non-invasively using PET imaging may enable us to predict better which patients will benefit from which Checkpoint Inhibitor Therapy (CkIT) treatment regimen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy | Experimental | Drug: [18F]F-AraG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.
- Measurable disease.
- ECOG performance status of 0, 1 or 2.
- Subjects are willing to be followed at the University of Iowa.
Key exclusion criteria (3 listed)
- Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
- Pregnant women or nursing mothers.
- Patients with severe claustrophobia.
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 |
|---|---|---|
| [18F]F-AraGTwo PET scans | Drug | Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy |
Primary outcome
[18F]F-AraG Quantification
Time frame: One Year
Quantitative assessment of tracer uptake by Standardized Uptake Value (SUV) based measurements within volumes of interest on pre- and on-treatment [18F]F AraG PET scans compared.
[18F]F AraG Correlation
Time frame: One Year
Comparison of quantitative change in tracer uptake between pre- and on-treatment with radiographic outcomes as defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) > 4 months.
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 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Muhammad Furqan, M.D. principal investigator
Holden Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]F-AraG in people with Advanced Non Small Cell Lung Cancer, run by CellSight Technologies, Inc. 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 4 inclusion and 3 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 24 Oct 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Amy Mundisev (319-356-1445, amy-mundisev@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[18F]F-AraG Quantification (time frame: One Year). The study lists 2 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 24 Oct 2024.