Non Small Cell Lung CancerPhase 2NCT04726215
Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer
A Phase 2 study testing [18F]F AraG in people with Non Small Cell Lung Cancer, run by CellSight Technologies, Inc. at 3 sites in United States.
Trial summary
This is a pilot study using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. 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?
- [18F]F AraG
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2021to 15 Oct 2024
- Phase
- Phase 2
- 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
- Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease.
- RECIST measurable disease.
- ECOG performance status of 0, 1 or 2.
- Life expectancy >/= 6 months at enrollment.
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
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Palo Alto Veterans Institute of Research
Palo Alto, California, 94304
Danny Kwon, 800-239-2820, DKwon@pavir.org
Nithya Vijayakumar, NVijayakumar@pavir.org
- Recruiting
Sutter Cancer Center
Sacramento, California, 95816
Michele Guillen Guillen, 916-887-4656, GuilleM1@sutterhealth.org
Lori Pruski-Clark, 916-453-5807
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
Hermina Munoz, 631-216-2990, Hermina.Munoz@stonybrookmedicine.edu
Roger Keresztes, M.D.
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 is a pilot study using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in [18F]F AraG PET signal before and after CkIT therapy, and to correlate this change in [18F]F AraG PET signal with a radiographic response.
Read the detailed description
Approximately 50 patients will undergo two research PET/CT scans with [18F]F AraG at two time points. Each patient will receive two 5 (+/-10%) mCi doses of [18F]F AraG, one for each imaging time point. Eligible subjects will undergo a pre-treatment [18F]F AraG PET/CT scan within 7 days prior to treatment, followed by treatment, and an on-treatment [18F]F AraG PET/CT within 7-14 days of treatment.
Objectives:
- Quantify [18F]F-AraG uptake in advanced NSCLC tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy).
- Correlate change in [18F]F AraG uptake in tumor lesions with radiographic response.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- [18F]F AraG
- 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 AraGDrug
PET imaging agent specific to activated T cells
What is being measured
The primary outcome is the main question the study is designed to answer.
[18F]F-AraG uptake signal
[18F]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start15 Apr 2021
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellSight Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepak Behera, MD, Principal investigator, CellSight Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726215
- Sponsor's protocol ID
- CST-FARAG-IO-MULT-201
- Status last verified
- Sep 2023
- First submitted
- 21 Jan 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levi J, Das M, Vasanawala MS, Behl D, Pomper M, Forde PM, Nakajima E, Sayre J, Shen B, Cabrera H, Del Mar N, Gullen M, Pierini M, Cox L, Lokre O, Perk T, Chae HD. [18F]F-AraG Uptake in Vertebral Bone Marrow May Predict Survival in Patients with Non-Small Cell Lung Cancer Treated with Anti-PD-(L)1 Immunotherapy. J Nucl Med. 2024 Dec 3;65(12):1869-1875. doi: 10.2967/jnumed.124.268253.
PubMed 39448270
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. 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
- NCT04726215
- Acronym / sponsor ID
- CST-FARAG-IO-MULT-201
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CellSight Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 27 Jan 2021 (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 pilot study using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in [18F]F AraG PET signal before and after CkIT therapy, and to correlate this change in [18F]F AraG PET signal with a radiographic response.
Detailed description
Approximately 50 patients will undergo two research PET/CT scans with [18F]F AraG at two time points. Each patient will receive two 5 (+/-10%) mCi doses of [18F]F AraG, one for each imaging time point. Eligible subjects will undergo a pre-treatment [18F]F AraG PET/CT scan within 7 days prior to treatment, followed by treatment, and an on-treatment [18F]F AraG PET/CT within 7-14 days of treatment.
Objectives:
- Quantify [18F]F-AraG uptake in advanced NSCLC tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy).
- Correlate change in [18F]F AraG uptake in tumor lesions with radiographic response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease.
- RECIST measurable disease.
- ECOG performance status of 0, 1 or 2.
- Life expectancy >/= 6 months at enrollment.
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 AraGPET imaging agent specific to activated T cells | Drug | – |
Primary outcome
[18F]F-AraG uptake signal
Time frame: two years
[18F]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 39448270Levi J, Das M, Vasanawala MS, Behl D, Pomper M, Forde PM, Nakajima E, Sayre J, Shen B, Cabrera H, Del Mar N, Gullen M, Pierini M, Cox L, Lokre O, Perk T, Chae HD. [18F]F-AraG Uptake in Vertebral Bone Marrow May Predict Survival in Patients with Non-Small Cell Lung Cancer Treated with Anti-PD-(L)1 Immunotherapy. J Nucl Med. 2024 Dec 3;65(12):1869-1875. doi: 10.2967/jnumed.124.268253.
- 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.
Deepak Behera, MD principal investigator
CellSight Technologies, Inc.
3 sites 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 Non Small Cell Lung Cancer, run by CellSight Technologies, Inc. at 3 sites 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SAMUEL QUEZADA (6507991589, squezada@cellsighttech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[18F]F-AraG uptake signal (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726215, which also lists 1 linked publication.
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 29 Sep 2023.