Actively Recruiting
A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer
Led by Amsterdam UMC, location VUmc · Updated on 2025-03-28
15
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
\[18F\]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).
CONDITIONS
Official Title
A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-small cell lung cancer (NSCLC) with biopsy negative for EGFR and ALK mutations
- Willing to provide archival or fresh biopsy at screening
- Stage IIIB-IV NSCLC planned for anti-PD-1 monotherapy
- High PD-L1 expression (≥50% Tumor Proportion Score)
- No prior systemic cancer therapy
- Able and willing to give informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- At least 18 years old on the day of consent
You will not qualify if you...
- Need for systemic corticosteroids (>10 mg prednisone daily equivalent) or immunosuppressive drugs within 14 days before study start
- Untreated or symptomatic brain metastases
- Another progressing cancer needing active treatment (except certain skin cancers or treated cervical cancer)
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Active infection requiring systemic treatment
- History of HIV infection
- Active Hepatitis B or C infection
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnant, breastfeeding, or planning to conceive during the study and up to 12 weeks after last [18F]F-AraG administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
Research Team
I
Idris Bahce, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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