Priming Immunotherapy in Advanced Disease With Radiation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non -Small Cell Lung Cancer
- Squamous Cell Carcinoma of the Head and Neck
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Subjects with front-line or relapsed NSCLC or relapsed HNSCC who are intended to receive standard of care immune checkpoint inhibitors without a contraindication to Stereotactic Body Radiation Therapy (SBRT) to a single cancer deposit greater than 1 cm (metastasis or primary cancer) will be enrolled...
Subjects with front-line or relapsed NSCLC or relapsed HNSCC who are intended to receive standard of care immune checkpoint inhibitors without a contraindication to Stereotactic Body Radiation Therapy (SBRT) to a single cancer deposit greater than 1 cm (metastasis or primary cancer) will be enrolled. Subjects will receive standard of care (SOC) immune checkpoint inhibitors and within 2 weeks of initiation, and will receive either: SBRT to target to achieve Biological Equivalent Dose (BED) > 100 Gy OR 30 Gy fractionated radiation therapy (RT) delivered as a 3 dimensional (3-D) dose. The lesion choice will be made by the treating radiation oncologist and will be directed to a single malignant focus (non-CNS) that measures ? 1 cm. Essentially, the goals of both techniques are the same but SBRT is reserved for lesions that are readily encompassed by a single field with large RT fractions in which dose-limiting organs are within safe limits.
Tracking Information
- NCT #
- NCT03313804
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: John Villano, MD, PhD University of Kentucky
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