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NCT03313804 · ClinicalTrials.gov registry record · Phase 2
Priming Immunotherapy in Advanced Disease With Radiation
A Phase 2 study of Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by John L. Villano, MD, PhD.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT03313804: Completed Phase 2 study of Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by John L. Villano, MD, PhD.
NCT03313804 is a Phase 2 study of Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck that has completed, run by John L. Villano, MD, PhD. The registered enrollment target is 76 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03313804, a Phase 2 study of Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by John L. Villano, MD, PhD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
Study Summary
This study proposes to treat metastatic non-small cell lung cancer (NSCLC) and head/neck squamous cell cancer (HNSCC) patients who are already initiating an immune checkpoint inhibitor (such as Nivolumab, Atezolizumab or Pembrolizumab) for disease treatment as per FDA approved guidelines. In these patients we will deliver a short-course radiation to a single systemic (non-CNS) site within 14 days of receiving the first dose of immune checkpoint inhibitors. This sequence allows radiation to release tumor antigens from immune inaccessible areas such as necrotic tumor or low perfusion to provide a robust anti-tumor immune response with immune checkpoint inhibitors. The primary objective is to assess six-month progression free survival (PFS) compared to historical control.
Primary Outcome
Progression-free survival will be calculated as a rate, time from enrollment in the study to progression at 6-months post enrollment.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Immune checkpoint inhibitor
Study Locations (1)
Kentucky
- University of Kentucky Markey Cancer Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2017-10-26 |
| Est. Completion | 2026-02-16 |
| Phase | Phase 2 |
What the finished NCT03313804 record still lists
NCT03313804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT03313804 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT03313804 about?
NCT03313804 is a clinical study titled "Priming Immunotherapy in Advanced Disease With Radiation". This study proposes to treat metastatic non-small cell lung cancer (NSCLC) and head/neck squamous cell cancer (HNSCC) patients who are already initiating an immune checkpoint inhibitor (such as Nivolumab, Atezolizumab or Pembrolizumab) for disease treatment as per FDA approved guidelines. In these p...
What is the current status of trial NCT03313804?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2017-10-26. Estimated completion is 2026-02-16.
What conditions does trial NCT03313804 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT03313804?
The interventions under investigation include: Radiation Therapy (RADIATION), Immune checkpoint inhibitor (DRUG).
Who is sponsoring clinical trial NCT03313804?
This trial is sponsored by John L. Villano, MD, PhD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03313804 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03313804's enrollment target sits among peer trials
76 274th of 454 higher than 177 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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