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Computed Tomography / Low Dose Radiation Therapy / Metastatic Lung Non Small Cell Carcinoma · Phase 1 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 registration for a first-in-human PET imaging agent combining copper-64 radiolabel with pembrolizumab to assess safety and visualize PD-1 expression in stage IV NSCLC. No results have been posted; the study is currently recruiting and designed to characterize adverse events and imaging biodistribution rather than clinical efficacy.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Oligoprogressive Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC…; age from 18 Years. Intervention: Treatment (pembrolizumab, 64CDP, SBRT, LDRT). n = 6. 1 site: United States.
This is a Phase 1 registration for a first-in-human PET imaging agent combining copper-64 radiolabel with pembrolizumab to assess safety and visualize PD-1 expression in stage IV NSCLC. No results have been posted; the study is currently recruiting and designed to characterize adverse events and imaging biodistribution rather than clinical efficacy.
This is a registry record only; no safety, efficacy, or imaging results are reported. Sample size (6 participants) is very small and insufficient to establish efficacy or generalizable safety profile.
No clinical impact can be assessed at this stage. Clinicians should await Phase 1 safety data and subsequent efficacy studies before considering this imaging agent for treatment response assessment in routine practice.
This is a Phase 1 safety and feasibility study of a novel PET imaging agent in a small planned cohort with no results yet reported in the registry record.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed at this stage. Clinicians should await Phase 1 safety data and subsequent efficacy studies before considering this imaging agent for treatment response assessment in routine practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07619599). This is a study registration, not published results. Lead sponsor: City of Hope Medical Center. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 6 participants (ESTIMATED). Conditions: Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Oligoprogressive Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8. Interventions: PROCEDURE: Computed Tomography; RADIATION: Copper Cu 64-DOTA-pembrolizumab; RADIATION: Low Dose Radiation Therapy; BIOLOGICAL: Pembrolizumab; PROCEDURE: Positron Emission Tomography; RADIATION: Stereotactic Body Radiation Therapy. Primary outcome measures: Incidence of treatment-related adverse event rates , Up to 14 days after 64Cu-DOTA-pembrolizumab infusion; 64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax) , Day 2 and day 44. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.