Pilot Study of 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy (SBRT) for Oligo-Progressive Non-Small Cell Lung Cancer (NSCLC)
City of Hope Medical Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. To describe the safety of administering copper Cu 64-DOTA-pembrolizumab (64Cu-DOTA-pembrolizumab) for PET imaging in patients receiving SBRT for NSCLC during pembrolizumab therapy. II. Evaluate 64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax) at baseline for oligoprogressive lesion(s) versus (vs) lesions that were not progressing on pembrolizumab therapy. SECONDARY OBJECTIVES: I. Evaluate change in SUVmax in non-progressing lesions given low dose radiation therapy (LDRT). II. Evaluate change in SUVmax on oligoprogressive lesions treated with SBRT. III.…