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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03313804
The ClinicalTrials.gov registry entry for NCT03313804 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The listed sponsor is John L. Villano, MD, PhD, which has 3 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.