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

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Dec 22, 2028 → Feb 10, 2030
See other at-risk trials from City of Hope Medical Center

Record History

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  1. Primary and study completion pushed from Dec 22, 2028 to Feb 10, 2030
    • Start date changed from estimate of Sep 14, 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 6 of 6 entries
  2. Recruitment opened
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07619599
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Oligoprogressive Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Related terms Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov