Imaging Immune T-Cell Changes During Anti-PD-1 Therapy in Lung Cancer
Tests a PET scan that shows activated immune T-cells in adults with lung cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced non-small cell lung cancer who are about to start anti-PD-1 treatment alone and have had no cancer drug treatment before. They will have [18F]F-AraG PET scans.
- Age
- Above 18 years
- Sex
- All sexes
- Disease stage
- Non-small cell lung cancer confirmed by biopsy, stage IIIB-IV, with high PD-L1 expression (TPS 50% or more).
- Earlier treatment
- No earlier systemic therapy for cancer. Anti-PD-1 treatment alone is planned.
- Biomarker or test result
- No EGFR or ALK mutations. PD-L1 expression of 50% or more (TPS).
Main reasons for not taking part
- Steroids above 10 mg daily prednisone equivalent or other immune-suppressing drugs within 14 days of day 0
- Brain metastases that are untreated or cause symptoms
- Another cancer that is getting worse or needs active treatment
- Lung disease such as interstitial lung disease or active non-infectious pneumonitis
- History of HIV, active hepatitis B or C, or active infection needing systemic therapy
Read by machine on 12 November 2026.
Where in Netherlands
- Amsterdam UMC StichtingAmsterdam, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Amsterdam UMC, location VUmc
- Trial code
- NCT05701176EU 2024-517960-45-00
- Record updated
- 18 August 2026
- Original description
[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).Read full original descriptionShow less
A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer
[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).
Inclusion: 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: 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; 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; Untreated or symptomatic brain metastases; 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.