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NCT04298606 · ClinicalTrials.gov registry record · Early Phase 1
A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence
A Early Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT04298606: Completed Early Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT04298606 is a Early Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04298606, a Early Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This early phase I trial studies the side effects of a vaccine called CIMAvax-EGF and to see how well it works in preventing lung cancer from developing in patients at high risk for lung cancer or coming back (recurrence) in stage IB-IIIA non-small cell lung cancer survivors. In many cancers such as lung cancer, there is a protein receptor called EGFR (epidermal growth factor receptor) that is overexpressed within these cancers. Activation of EGFR has shown to lead to tumor growth and development. Previous studies have indicated that EGFR activation is present in the airways of cancer-free subjects as well. CIMAvax-EGF vaccine works by causing the body to make antibodies against EGF that is being produced that could be possibly driving the risk for developing cancer.
Primary Outcome
The response to the vaccine will be measured using circulating EGF and anti-EGF antibodies replicating the results from the Cuban and Roswell trials. Human EGF will be determined by the Roswell Park Flow and Image Cytometry CCSG supported Resource using a commercial enzyme-linked immunosorbent assay (ELISA) assay (R\&D Systems, Minneapolis, MN). EGF antibodies will also be determined, by the Roswell Park Flow and Image Cytometry Resource using an in-house assay developed in cooperation with the
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BIOLOGICAL Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-11-22 |
| Est. Completion | 2026-02-06 |
| Phase | Early Phase 1 |
What the finished NCT04298606 record still lists
NCT04298606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04298606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04298606 about?
NCT04298606 is a clinical study titled "A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence". This early phase I trial studies the side effects of a vaccine called CIMAvax-EGF and to see how well it works in preventing lung cancer from developing in patients at high risk for lung cancer or coming back (recurrence) in stage IB-IIIA non-small cell lung cancer survivors. In many cancers such as...
What is the current status of trial NCT04298606?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2021-11-22. Estimated completion is 2026-02-06.
What interventions are being tested in trial NCT04298606?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04298606?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04298606's enrollment target sits among peer trials
20 1157th of 2000 higher than 709 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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