Priming Immunotherapy in Advanced Disease With Radiation

ClinicalTrials.gov ID: NCT03313804

Public ClinicalTrials.gov record NCT03313804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 8, 2026, 5:34 AM EDT

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03313804
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: John L. Villano, MD, PhD; Other
Enrollment: 76 participants

Conditions and interventions

Conditions

Interventions

Immune checkpoint inhibitor Drug
Radiation Therapy Radiation

Drug · Radiation

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 25, 2017
Primary completion: Feb 15, 2024
Completion: Feb 15, 2026
Last update posted: Mar 10, 2026

2017 – 2026

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
University of Kentucky Markey Cancer Center	Lexington	Kentucky	40536	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03313804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 10, 2026 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03313804 live on ClinicalTrials.gov.

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