Imaging changes in T-cell activity after anti-PD-1 therapy in lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.