Advanced Lung Non-Small Cell CarcinomaEarly Phase 1NCT04186988
[18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy
A Early Phase 1 study testing Fluorine F 18 Ara-G in people with Advanced Lung Non-Small Cell Carcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by University of California, Davis.
Trial summary
This trial studies how well [18F]-AraG works in detecting T-cell activation in patients with non-small cell lung cancer that has spread to other places in the body (advanced), who are undergoing PD-1/PD-L1-directed therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8
- What is being tested?
- Fluorine F 18 Ara-G
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2019to 12 Mar 2020
- Phase
- Early 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
- This study is open to all adult subjects with histological confirmation of NSCLC planned to undergo treatment with a PD-1 or PD-L1 inhibitor either as monotherapy or as combination therapy with concurrent chemotherapy as treatment for advanced/metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3 at the time of enrollment
- Patient with life expectancy >= 24 weeks from the time of screening to the study
- Ability to sign and understand the Institutional Review Board (IRB)-approved consent form in English
- Ability to remain motionless for up to 30 minutes per scan
Who cannot join
- Patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed)
- Severe impaired renal function with estimated glomerular filtration rate < 30 mL/min/1.73 m^2 and/or on dialysis
- Pregnancy
- Breast feeding an infant
- Prior treatment with anti-PD-1/PD-L1 inhibitor
- Localized/locally advanced disease with anti PD-1/PD-L1 given as consolidation
About this study
Official title: Imaging of T-Cell Activation With [18F]-AraG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-Directed Therapy
This trial studies how well [18F]-AraG works in detecting T-cell activation in patients with non-small cell lung cancer that has spread to other places in the body (advanced), who are undergoing PD-1/PD-L1-directed therapy. [18F]-AraG is a "radiotracer" which attaches to immune cells directed at the cancer and shines a light that can be seen using a special camera, called a "positron emission tomography" or "PET" scanner. [18F]-AraG may improve the ability to detect a response of the cancer in the body to immunotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To quantify fluorine F 18 Ara-G ([18F]-AraG) uptake (standardized uptake value [SUV]) in advanced non-small cell lung cancer (NSCLC) tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in both patients treated with PD-1/PD-L1 monotherapy and in patients treated with immunotherapy/chemotherapy combination therapy.
II. To correlate change in [18F]-AraG uptake before and after the start of therapy with radiographic response in patients treated with immunotherapy.
OUTLINE:
Patients receive [18F]-AraG intravenously (IV) and then undergo PET/CT over 2 hours at baseline and within 2 weeks after starting immunotherapy. Patients may also undergo blood sample collection.
After completion of study treatment, patients are followed for up to 12 months.
- Conditions
- Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8
- Being tested
- Fluorine F 18 Ara-G
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorine F 18 Ara-GDrug
Also called 18F-F-Ara-G, [18F]F-ara-G, [18F]F-AraG
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic ([18F]-AraG) | Experimental | Patients receive [18F]-AraG IV and then undergo PET/CT over 2 hours at baseline and within 2 weeks after starting immunotherapy. Patients may also undergo blood sample collection. Receives: Drug: Fluorine F 18 Ara-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorine F 18 Ara-G ([18F]-AraG) uptake values in advanced non-small cell lung cancer (NSCLC) before and after treatment with anti-PD-1/PD-L1 therapy obtained
The positron emission tomography (PET) images will be interpreted qualitatively and semi-quantitatively on a lesion-by-lesion basis. Semi-quantitative analysis will be employed as follows: (a) Regions of interest (ROIs) will be placed around tracer avid foci suspicious for malignancy in order to obtain standardized uptake value (SUV) parameters, including maximum SUV (SUVmax), SUVpeak, SUVmean; (b) SUV data will be recorded along with volumetric and positional information in a standardized form.
Measured: Baseline up to within 2 weeks after starting immunotherapy
Secondary outcomes (2)
Mean change in SUV
All SUV measurements will be summarized descriptively, separately for baseline and follow-up. Descriptive statistics for the SUVs will be done on a subject basis and a per lesion basis. Graphical summaries including box plots will be prepared to illustrate distributions and detect outliers or other findings; numerical summaries will include, mean, standard deviation (SD), median, and range as appropriate. For each target lesion, the scan 1 and scan 2 SUV will be determined and compared. A mixed-model repeated-measures analysis of variance (ANOVA) will be used to estimate the mean change in SUV from scan 1 to scan 2, allowing for possible need to account for between-patient random variation both in baseline level of SUV and amount of change. The primary result will be an estimate of the mean change in SUV, with a 95% confidence interval, along with the between patient and within-patient, between-lesion variation.
Measured: Baseline up to within 2 weeks after starting immunotherapy
Correlation between [18F]-AraG uptake and clinical response
Measured: Baseline up to within 2 weeks after starting immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start5 Nov 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Unable to recruit to study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), CellSight Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Julie Sutcliffe, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186988
- Sponsor's protocol ID
- 1471901
- Other IDs
- NCI-2019-07768, CCHO030, P30CA093373
- Status last verified
- Jan 2022
- First submitted
- 2 Dec 2019
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of T-Cell Activation With [18F]-AraG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-Directed Therapy
- ClinicalTrials.gov ID
- NCT04186988
- Acronym / sponsor ID
- 1471901
- Conditions
- Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit to study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), CellSight Technologies, Inc.
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 5 Dec 2019 (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 trial studies how well [18F]-AraG works in detecting T-cell activation in patients with non-small cell lung cancer that has spread to other places in the body (advanced), who are undergoing PD-1/PD-L1-directed therapy. [18F]-AraG is a "radiotracer" which attaches to immune cells directed at the cancer and shines a light that can be seen using a special camera, called a "positron emission tomography" or "PET" scanner. [18F]-AraG may improve the ability to detect a response of the cancer in the body to immunotherapy.
Detailed description
PRIMARY OBJECTIVES:
- To quantify fluorine F 18 Ara-G ([18F]-AraG) uptake (standardized uptake value [SUV]) in advanced non-small cell lung cancer (NSCLC) tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in both patients treated with PD-1/PD-L1 monotherapy and in patients treated with immunotherapy/chemotherapy combination therapy.
II. To correlate change in [18F]-AraG uptake before and after the start of therapy with radiographic response in patients treated with immunotherapy.
OUTLINE:
Patients receive [18F]-AraG intravenously (IV) and then undergo PET/CT over 2 hours at baseline and within 2 weeks after starting immunotherapy. Patients may also undergo blood sample collection.
After completion of study treatment, patients are followed for up to 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic ([18F]-AraG) | Experimental | Drug: Fluorine F 18 Ara-GPatients receive [18F]-AraG IV and then undergo PET/CT over 2 hours at baseline and within 2 weeks after starting immunotherapy. Patients may also undergo blood sample collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- This study is open to all adult subjects with histological confirmation of NSCLC planned to undergo treatment with a PD-1 or PD-L1 inhibitor either as monotherapy or as combination therapy with concurrent chemotherapy as treatment for advanced/metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3 at the time of enrollment
- Patient with life expectancy >= 24 weeks from the time of screening to the study
- Ability to sign and understand the Institutional Review Board (IRB)-approved consent form in English
- Ability to remain motionless for up to 30 minutes per scan
Key exclusion criteria (6 listed)
- Patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed)
- Severe impaired renal function with estimated glomerular filtration rate < 30 mL/min/1.73 m^2 and/or on dialysis
- Pregnancy
- Breast feeding an infant
- Prior treatment with anti-PD-1/PD-L1 inhibitor
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 |
|---|---|---|
| Fluorine F 18 Ara-GAlso: 18F-F-Ara-G, [18F]F-ara-G, [18F]F-AraGGiven IV | Drug | Diagnostic ([18F]-AraG) |
Primary outcome
Fluorine F 18 Ara-G ([18F]-AraG) uptake values in advanced non-small cell lung cancer (NSCLC) before and after treatment with anti-PD-1/PD-L1 therapy obtained
Time frame: Baseline up to within 2 weeks after starting immunotherapy
The positron emission tomography (PET) images will be interpreted qualitatively and semi-quantitatively on a lesion-by-lesion basis. Semi-quantitative analysis will be employed as follows: (a) Regions of interest (ROIs) will be placed around tracer avid foci suspicious for malignancy in order to obtain standardized uptake value (SUV) parameters, including maximum SUV (SUVmax), SUVpeak, SUVmean; (b) SUV data will be recorded along with volumetric and positional information in a standardized form.
2 secondary outcomes
Mean change in SUV
Time frame: Baseline up to within 2 weeks after starting immunotherapy
Correlation between [18F]-AraG uptake and clinical response
Time frame: Baseline up to within 2 weeks after starting immunotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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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.
Julie Sutcliffe principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluorine F 18 Ara-G in people with Advanced Lung Non-Small Cell Carcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by University of California, Davis.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 withdrawn before enrolling participants, so there are no results.
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?
Fluorine F 18 Ara-G ([18F]-AraG) uptake values in advanced non-small cell lung cancer (NSCLC) before and after treatment with anti-PD-1/PD-L1 therapy obtained (time frame: Baseline up to within 2 weeks after starting immunotherapy). 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 1 Feb 2022.