Study of 64Cu-DOTA-Pembrolizumab PET Imaging to Assess Treatment Response in Stage IV Non-Small Cell Lung Cancer Receiving Pembrolizumab and Radiation Therapy

What this Trial Is About

Researchers are evaluating a new PET imaging agent called 64Cu-DOTA-pembrolizumab to assess treatment response in patients with stage IV non-small cell lung cancer NSCLC who are already receiving pembrolizumab. This phase I trial aims to study the safety and side effects of this imaging agent and how well it can differentiate between tumors that are growing and those that are not during pembrolizumab treatment. The trial is sponsored by City of Hope Medical Center. Participants receive standard pembrolizumab intravenously on day 0, followed by 64Cu-DOTA-pembrolizumab infusion on day 1 and a PET scan on day 2. They then undergo stereotactic body radiation therapy SBRT over 3-5 treatments within 10-12 days, with possible low-dose radiation therapy LDRT during this period based on PET scan results. Additional pembrolizumab doses are given on days 21 and 42, followed by another 64Cu-DOTA-pembrolizumab infusion on day 43 and PET scan on day 44. A CT scan is also performed during the study. Throughout the study, participants are monitored for treatment-related side effects up to 14 days after the imaging agent infusion and undergo various PET imaging measurements at baseline and follow-up. Researchers evaluate changes in tumor uptake values on PET scans to understand treatment response. After completing the treatment period, patients are followed for one year to assess safety and outcomes, with ongoing evaluations including laboratory tests and imaging.

A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab