About this trial
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.
Eligibility criteria
Qualifiers
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Disqualifiers
Patient planned to stop pembrolizumab at time of referral for SBRT
Vaccination with live attenuated vaccines within 4 weeks of study agent administration except forthcoming coronavirus disease 2019 (COVID-19) and flu vaccines
Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
Chronic systemic corticosteroids at physiologic doses not to exceed 5 mg/day of prednisone or equivalent
Trial design
Treatments tested in this trial
- Computed Tomography
- Copper Cu 64-DOTA-pembrolizumab
- Low Dose Radiation Therapy
- Pembrolizumab
- Positron Emission Tomography
- Stereotactic Body Radiation Therapy
Treatment groups
Sponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator