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.
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
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
Single group
Computed Tomography
Procedure/SurgeryUndergo CT
Copper Cu 64-DOTA-pembrolizumab
RadiationGiven IV
Low Dose Radiation Therapy
RadiationUndergo LDRT
Pembrolizumab
Biological/VaccineGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
Incidence of treatment-related adverse event rates
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0, delineated by grade and attribution. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax)
Will evaluate CDP SUVmax at baseline for oligoprogressive lesions(s) versus lesions that are not progressing on pembrolizumab therapy. For this comparison, each patent will have both type of lesion(s) to be eligible. If the patient has more than one oligoprogressive lesion, the median SUVmax over the oligoprogressive lesions will be the key metric. Similarly if the patient has more than one non-oligoprogressive lesion the median SUVmax will be the key metric for that type of lesion within a patient. Only lesions measuring at least 2cm will be considered and if \> 5 lesions, of either class, the target lesions will be identified before the CDP scan and if two qualifying lesions of the two different groups are in the same organ, they will be selected preferentially as the target lesions. As a result for each patient will have an SUVmax for oligoprogressive disease and an SUVmax for non-oligoprogressive disease.
Change in SUV-max of 64CDP in non-progressing lesions that were given low dose radiation therapy
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-stereotactic body radiation therapy (SBRT). Non-parametric tests may also be explored in addition to the t-test.
Change in SUV-max of 64CDP in oligoprogressive lesions that were given SBRT
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT. Non-parametric tests may also be explored in addition to the t-test.
Change in SUV-max of 64CDP in non-progression lesions not given LDRT or SBRT
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT. Non-parametric tests may also be explored in addition to the t-test.
Change in SUVpeak
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT. Non-parametric tests may also be explored in addition to the t-test.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
