Advanced Stage Non Small Cell Lung Cancer / [18F]F-AraG PET scan · Interventional Study

A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is an active, unfinished clinical imaging registry record for a planned exploratory study investigating [18F]F-AraG PET as a biomarker of immune activation during anti-PD-1 therapy in advanced NSCLC. No results have been posted; the study aims to correlate baseline and on-treatment imaging uptake with tumor response at 6 and 12 weeks.

What was studied

Interventional, Single Group, Open label, Diagnostic purpose. Advanced Stage Non-small Cell Lung Cancer; age from 18 Years. Intervention: [18F]F-AraG PET procedures. n = 15. 1 site: Netherlands.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active, unfinished registry record for a small exploratory imaging study with no results yet reported; it describes a planned diagnostic imaging biomarker investigation in early stages.

Study design

As stated by the source record.

MethodsPrimary outcome measures: To assess the relative change in uptake of [18F]F-AraG in tumor lesions and lymphoid organs on anti-PD-1 treatment (assessed at six weeks); To correlate baseline [18F]F-AraG uptake and tumor response to anti-PD-1 therapy (assessed at twelve weeks); To correlate the change in [18F]F-AraG uptake between baseline and on-treatment and tumor response to anti-PD-1 therapy (assessed at twelve weeks)

DesignInterventional, Single Group, Open label, Diagnostic purpose

PopulationAdvanced Stage Non-small Cell Lung Cancer; age from 18 Years

Sample size15

Intervention[18F]F-AraG PET procedures

Setting1 site: Netherlands

Reported figures

Quoted from the source exactly as published.

Planned enrollment15

Primary outcome measure 1Relative change in [18F]F-AraG uptake in tumor lesions and lymphoid organs on anti-PD-1 treatment at six weeks

Primary outcome measure 2Correlation of baseline [18F]F-AraG uptake and tumor response to anti-PD-1 therapy at twelve weeks

Primary outcome measure 3Correlation of change in [18F]F-AraG uptake between baseline and on-treatment and tumor response to anti-PD-1 therapy at twelve weeks

Caveats

This is a registry record only; no results are reported and the study is actively recruiting.
Very small planned sample size (15 participants) limits generalizability and statistical power.
No control arm or comparator specified; study design is single-arm imaging exploration.
Surrogate imaging endpoints; clinical outcome data and validation are not yet reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm diagnostic imaging study; no control group or comparator arm specified.

Directness

limited

Measures imaging biomarker uptake and correlation with tumor response, not clinical outcomes.

Consistency

insufficient

Registry record only; no results reported yet to assess consistency.

Risk of bias

insufficient

Blinding, outcome assessment methods, and analysis plan not detailed in registry record.

Sample adequacy

limited

Estimated enrollment 15 participants; very small sample size for imaging biomarker validation.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05701176). This is a study registration, not published results. Lead sponsor: Amsterdam UMC, location VUmc. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 15 participants (ESTIMATED). Conditions: Advanced Stage Non-small Cell Lung Cancer. Interventions: DIAGNOSTIC_TEST: [18F]F-AraG PET scan. Primary outcome measures: To assess the relative change in uptake of [18F]F-AraG in tumor lesions and lymphoid organs on anti-PD-1 treatment , six weeks; To correlate baseline [18F]F-AraG uptake and tumor response to anti-PD-1 therapy , twelve weeks; To correlate the change in [18F]F-AraG uptake between baseline and on-treatment and tumor response to anti-PD-1 therapy , twelve weeks. Brief summary: \[18F\]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the SHARP trial is to investigate changes in \[18F\]F-AraG uptake following Anti-PD-1 therapy in patients with non-small cell lung cancer (NSCLC).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Advanced Stage Non Small Cell Lung Cancer[18F]F-AraG PET scanAmsterdam UMC, location VUmcNCT05701176