\[18F\]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).
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)
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.
Amsterdam UMC, location VUmc
Lead sponsor
Boehringer Ingelheim
Collaborator