Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
NCT03546829 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-01-14
Summary
The first phase of this study was an open label, randomized pilot study. Enrollment for this phase is now complete.
The second phase is a single arm phase 1 safety study. Patients planned to undergo precision hypofractionated radiation to all sites of oligoprogression will receive vancomycin for 1 week before RT and for 1 month after start of RT, and asked to provide stool and blood samples as outlined in the Safety Trial study table.
Conditions
- Early Stage Non-Small Cell Lung Cancer
Interventions
- DRUG
-
125 mg, 4x daily for 5 weeks
- RADIATION
-
Precision hypofractionated radiation
Patients planned to undergo precision hypofractionated radiation to all sites of oligoprogression and will receive vancomycin for 1 week before RT and for 1 month after start of RT, and asked to provide stool and blood samples as outlined in the Safety Trial study table.
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Steven Feigenberg, MD · University of Pennsylvania
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-05
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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