Recruiting
Phase 1

Antimicrobial Therapy & Precision Radiation Therapy

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT03546829

Conditions

Early Stage Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vancomycin

Precision hypofractionated radiation

Study Details

Brief 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

Study ID

NCT03546829

Start date

Mar 5, 2019

Status verified date

Jan, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 - Experimental

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.

Interventions

Vancomycin

125 mg, 4x daily for 5 weeks

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.

Primary outcome measure

  • Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma). [ Time Frame: 2 years ]
  • Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy [ Time Frame: 2 years ]
  • Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Ching Lai

267-250-9244ching.lai@pennmedicine.upenn.edu

RadOnc Clinical Research Unit

radonccru@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Ching Lai

267-250-9244ching.lai@pennmedicine.upenn.edu

RadOnc Clinical Research Unit

radonccru@pennmedicine.upenn.edu

Principal Investigator:

Steven Feigenberg, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-01-14.