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NCT03546829RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 14 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
10 (estimated)
First submitted
23 May 2018
Start date
5 Mar 2019
Primary completion date
31 Dec 2027
Lead sponsor
Abramson Cancer Center at Penn Medicine
Diseases
Lung cancer
NCT number
NCT03546829

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 10
  • From 5 Mar 2019 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Randomized Pilot Inclusion
  • Patients planned to receive Stereotactic Body Radiotherapy (SBRT) to a biopsy-proven or clinically-suspected NSCLC
  • Age \>18 years' old
  • Patient capable of giving informed consent
    • Randomized Pilot Exclusion
  • Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
  • Active infection with oral temperature \>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. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).
  • Documented history of HIV, HBV or HCV
  • Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (within 2 years of lung cancer diagnosis) or Helicobacter Pylori infection (untreated)
  • Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
  • Patients on anti-diarrheal medications
  • Patients on probiotics
    • Safety Trial Inclusion
  • Patients planned to receive precision hypofractionated radiation (SBRT or an ablative dose of radiation is used if SBRT is not appropriate or if insurance does not approve - i.e. \> 30 Gy in 10 fraction equivalent) to all sites of oligoprogressive NSCLC who progressed after 1st line systemic therapy for metastatic disease which included immunotherapy or a tyrosine kinase inhibitors (TKI) for NSCLC
  • The number of sites of progression are \< 5 sites.
  • Age \>18 years' old
  • Patient capable of giving informed consent
    • Safety Trial Exclusion
  • Evidence of untreated CNS or leptomeningeal disease
  • Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
  • Active infection with oral temperature \>100°F
  • Use of oral 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. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S3).
  • Documented history of HIV, HBV or HCV
  • Patients on daily anti-diarrheal medications
  • Use of probiotics during the 4 weeks prior to radiotherapy or during radiotherapy

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.