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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam UMC, location VU University Medical Center
RECRUITING
Amsterdam
Contact Information
Primary
Idris Bahce, MD, PhD
i.bahce@amsterdamumc.nl
+31204444782
Time Frame
Start Date: 2022-11-03
Estimated Completion Date: 2028-01
Participants
Target number of participants: 15
Treatments
Experimental: [18F]F-AraG PET procedures
All patients will undergo a total of 3 \[18F\]F-AraG PET scanning procedures at T=0, T=2 weeks and T=6 weeks.
Sponsors
Collaborators: Boehringer Ingelheim
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov