A new imaging tracer could predict immunotherapy success in lung cancer
NCT ID NCT05701176
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This study tests whether a special PET scan tracer, [18F]F-AraG, can visualize activated T-cells in tumors and healthy tissue of patients with advanced non-small cell lung cancer. The goal is to see if changes in tracer uptake during anti-PD-1 immunotherapy can predict how well the treatment works. Participants will undergo PET scans before starting therapy and again after 2 and 6 weeks of treatment, with results compared to tumor response at 6 and 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A PET imaging tracer called [18F]F-AraG, used to visualize activated T-cells in the body.
- What this could lead to
- If successful, this imaging method could help doctors predict early whether immunotherapy is working in lung cancer, guiding treatment decisions.
- What could go wrong
- This is a small early-stage study, and the tracer's ability to predict response is unproven. It may not reliably reflect T-cell activity or correlate with treatment outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed NSCLC, a histological biopsy is mandatory, negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations * Be willing to provide either archival biopsy or fresh biopsy at screening. * Stage IIIB-IV patients that are planned to be treated with anti-PD-1 monotherapy * High PD-L-1 expression (≥50% TPS) * No prior systemic therapy for the treatment of cancer * Be willing and able to provide written informed consent for the trial. * Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale * Be above 18 years of age on day of signing informed consent. Exclusion Criteria: * Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Untreated or symptomatic brain metastases * Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Evidence of interstitial lung disease or active, non-infectious pneumonitis. * Active infection requiring systemic therapy. * A history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Active Hepatitis B or C. * Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last administration of \[18F\]F-AraG.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC, location VU University Medical Center
RECRUITINGAmsterdam, 1081 HV, Netherlands