Non-small Cell Lung Cancer (NSCLC)Phase 1NCT04524195
PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study testing [18F]F-AraG Injection in people with Non-small Cell Lung Cancer (NSCLC), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- [18F]F-AraG Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 27 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age 18 years or older and willing and able to provide informed consent.
- Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment.
- For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study.
Who cannot join
- Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis.
- Pregnant female patients; breastfeeding female patients.
- Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
- Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
- Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of PET 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 is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).
Read the detailed description
The purpose of this study is to find out how the radiotracer called [18F]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. [18F]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent.
Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits.
A baseline [18F]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- [18F]F-AraG Injection
- Keywords
- J19119, PET/CT, [18F]F-AraG, NSCLC, PD-1, PD-L1, immunotherapy
- 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.
[18F]F-AraG InjectionDrug
Single dose of 5 mCi+/- [18F]F-AraG IV injection followed by the PET/CT scan. A baseline [18F]F-AraG PET/CT will be performed at about 0-7 days before patient receives the first dose of PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed at less than 14 days after the first dose of PD-1/PD-L1 immunotherapy is administered and before the second dose of PD-1/PD-L1 immunotherapy is given.
| Study group | Role | What they receive |
|---|---|---|
| [18F]F-AraG | Experimental | A one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point. Receives: Drug: [18F]F-AraG Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1
Percent Change in standard uptake value (SUV) of [18F]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy.
Measured: Baseline and 10-14 days after first dose of neoadjuvant therapy
Percent pathologic response at the time of surgery
100% minus the percentage of viable tumor remaining in the tumor bed.
Measured: At the time of surgery
Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient
Spearman correlation coefficient will be calculated in assessing the correlation between [18F]F-AraG uptake and pathologic response.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Feb 2021
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Why it stopped: The study is terminated because the PI left the institution.
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 Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CellSight Technologies, Inc., Stand Up To Cancer
- Responsible party
- Sponsor
- Investigators
- Martin Pomper, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524195
- Sponsor's protocol ID
- J19119
- Other IDs
- IRB00208724
- Status last verified
- Jan 2024
- First submitted
- 19 Aug 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of PET 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
- NCT04524195
- Acronym / sponsor ID
- J19119
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- J19119, PET/CT, [18F]F-AraG, NSCLC, PD-1, PD-L1, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is terminated because the PI left the institution.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- CellSight Technologies, Inc., Stand Up To Cancer
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 24 Aug 2020 (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 is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).
Detailed description
The purpose of this study is to find out how the radiotracer called [18F]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. [18F]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent.
Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits.
A baseline [18F]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]F-AraG | Experimental | Drug: [18F]F-AraG InjectionA one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older and willing and able to provide informed consent.
- Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment.
- For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study.
Key exclusion criteria (5 listed)
- Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis.
- Pregnant female patients; breastfeeding female patients.
- Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
- Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
- Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.
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-AraG InjectionSingle dose of 5 mCi+/- [18F]F-AraG IV injection followed by the PET/CT scan. A baseline [18F]F-AraG PET/CT will be performed at about 0-7 days before patient receives the first dose of PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed at less than 14 days after the first dose of PD-1/PD-L1 immunotherapy is administered and before the second dose of PD-1/PD-L1 immunotherapy is given. | Drug | [18F]F-AraG |
Primary outcome
Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1
Time frame: Baseline and 10-14 days after first dose of neoadjuvant therapy
Percent Change in standard uptake value (SUV) of [18F]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy.
Percent pathologic response at the time of surgery
Time frame: At the time of surgery
100% minus the percentage of viable tumor remaining in the tumor bed.
Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient
Time frame: 5 years
Spearman correlation coefficient will be calculated in assessing the correlation between [18F]F-AraG uptake and pathologic response.
Results and safety
The study was stopped early (reason given: The study is terminated because the PI left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Martin Pomper, M.D., Ph.D. principal investigator
Johns Hopkins University
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 [18F]F-AraG Injection in people with Non-small Cell Lung Cancer (NSCLC), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 5 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: stopped early, as of the sponsor's last update on 17 Jan 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 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?
The study was stopped early (reason given: The study is terminated because the PI left the institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1 (time frame: Baseline and 10-14 days after first dose of neoadjuvant therapy). 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 17 Jan 2024.