Safety of combining antimicrobial therapy with precision radiation for lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety of using vancomycin alongside precision hypofractionated radiation therapy in patients with oligoprogressive non-small cell lung cancer (NSCLC). In the second phase, participants will receive vancomycin for one week prior to radiation treatment and for one month afterward, while providing stool and blood samples for analysis. The study aims to assess the safety and potential benefits of this combined approach in managing early-stage NSCLC.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Steven Feigenberg, MD — University of Pennsylvania
• Study coordinator: Ching Lai
• Email: ching.lai@pennmedicine.upenn.edu
• Phone: 267-250-9244

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.