Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT03546829

Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-01-14

10

Participants Needed

1

Research Sites

512 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients planned to receive stereotactic body radiotherapy (SBRT) for biopsy-proven or suspected non-small cell lung cancer
  • Age over 18 years
  • Patient capable of giving informed consent
  • Patients planned to receive precision hypofractionated radiation (SBRT or ablative dose if SBRT not suitable) to all sites of oligoprogressive NSCLC after first line systemic therapy including immunotherapy or tyrosine kinase inhibitors
  • Fewer than 5 sites of progression
  • Patient capable of giving informed consent
Not Eligible

You will not qualify if you...

  • Use of antibiotics, antifungal, antivirals, or antiparasitics during the 4 weeks prior to registration
  • Active infection with oral temperature over 100°F
  • Use of corticosteroids, methotrexate, or immunosuppressive drugs during the 4 weeks prior to registration
  • Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy, with chemotherapy not allowed before collection of 30-day post-treatment sample
  • Documented history of HIV, HBV, or HCV
  • Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate or severe irritable bowel syndrome, persistent infectious gastroenteritis, colitis, gastritis, persistent or chronic diarrhea of unknown cause, recent Clostridium Difficile infection, or untreated Helicobacter Pylori infection
  • Major gastrointestinal surgery (except cholecystectomy and appendectomy) within past five years or any major bowel resection
  • Use of anti-diarrheal medications
  • Use of probiotics
  • Evidence of untreated central nervous system or leptomeningeal disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

C

Ching Lai

CONTACT

R

RadOnc Clinical Research Unit

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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