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NCT07619599 · ClinicalTrials.gov registry record · Phase 1
A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab
A Phase 1 study, sponsored by City of Hope Medical Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT07619599: Clinical Trial Phase 1 study, sponsored by City of Hope Medical Center.
NCT07619599 is a Phase 1 study that has not yet begun recruiting, run by City of Hope Medical Center. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07619599, a Phase 1 study, has not yet begun recruiting, sponsored by City of Hope Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- RADIATION Low Dose Radiation Therapy
- RADIATION Copper Cu 64-DOTA-pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2026-09-14 |
| Est. Completion | 2028-12-22 |
| Phase | Phase 1 |
What is known before NCT07619599 opens enrollment
NCT07619599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT07619599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07619599 about?
NCT07619599 is a clinical study titled "A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab". 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. 64...
What is the current status of trial NCT07619599?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2026-09-14. Estimated completion is 2028-12-22.
What interventions are being tested in trial NCT07619599?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Low Dose Radiation Therapy (RADIATION), Copper Cu 64-DOTA-pembrolizumab (RADIATION).
Who is sponsoring clinical trial NCT07619599?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07619599's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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