TheranosticTrials.org

Clinical Trial · NCT07619599

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

Overview

This phase I trial studies the safety and side effects of a new positron emission tomography (PET) imaging agent called 64Cu-DOTA-pembrolizumab to see how well it works in determining treatment response for patients with stage IV non-small cell lung cancer (NSCLC) already receiving pembrolizumab. 64Cu-DOTA-pembrolizumab consists of a monoclonal antibody, pembrolizumab, that binds to a protein called PD-1 that is expressed on tumor cells. PET scans can then visualize the tumor cells using 64Cu, a radioactive substance. 64Cu-DOTA-pembrolizumab PET scans may be safe and useful to doctors in telling the difference between tumors that are still growing and areas that are not growing in patients with stage IV NSCLC receiving pembrolizumab treatment.

Sponsor

City of Hope Medical Center

Phase

Phase 1

Contacts

Sagus Sampath (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07619599

Drug / Compound

DOTA-Pembrolizumab

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Antibodies
Chelator: DOTA

Eligibility

Inclusion

  • * Documented informed consent of the participant and/or legally authorized representative
  • Histologically confirmed stage IV non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Age: ≥ 18 years
  • Assent, when appropriate, will be obtained per institutional guidelines

Exclusion

  • * Patient planned to stop pembrolizumab at time of referral for SBRT
  • Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration with the exception of:
  • Chronic systemic corticosteroids at physiologic doses not to exceed 5 mg/day of prednisone or equivalent
  • Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
  • Vaccination with live attenuated vaccines within 4 weeks of study agent administration except forthcoming coronavirus disease 2019 (COVID-19) and flu vaccines