Imaging changes in T-cell activity after anti-PD-1 therapy in lung cancer
A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer
This study is testing if special imaging can show changes in T-cell activity in patients with advanced lung cancer after they receive a specific treatment to see if it helps doctors better understand their tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05701176 on ClinicalTrials.gov |
What this trial studies
This clinical imaging study aims to evaluate the uptake of the tracer [18F]F-AraG in activated T-cells following anti-PD-1 therapy in patients with advanced non-small cell lung cancer (NSCLC). Participants will undergo three longitudinal PET scans to assess changes in T-cell activity during treatment. The study seeks to improve the characterization of the tumor microenvironment, potentially aiding in the identification of tumors with high concentrations of activated T-cells. By using non-invasive imaging techniques, the research hopes to enhance patient selection for immunotherapy strategies.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed advanced stage NSCLC who are planned to receive anti-PD-1 monotherapy and have high PD-L-1 expression.
Not a fit: Patients with prior systemic cancer treatment or those requiring systemic immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective immunotherapy strategies for patients with advanced NSCLC.
How similar studies have performed: While the use of imaging to profile the tumor microenvironment is a growing field, this specific approach using [18F]F-AraG is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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. * 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. * 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.
Where this trial is running
Amsterdam
- Amsterdam UMC, location VU University Medical Center — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Idris Bahce, MD, PhD — Amsterdam UMC, location VUmc
- Study coordinator: Idris Bahce, MD, PhD
- Email: i.bahce@amsterdamumc.nl
- Phone: +31204444782
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.