NCT03546829 · Abramson Cancer Center at Penn Medicine
Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
What this study is about
The first phase of this study was an open label, randomly assigned pilot study. Enrollment for this phase is now complete. The second phase is a single treatment group$1 phase 1 safety study.
View original scientific description
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.
Interventions
DRUG
Vancomycin
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.
Primary outcome measures
Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma).
Time frame: 2 years
The primary endpoint is IFN-gamma cytokine expression at Day 30 (+/- 2) collection compared to the pre-radiation level. It will be analyzed using generalized linear mixed models.
Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy
Time frame: 2 years
The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v4.0 \> or = grade 3 (Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL). This will be evaluated during treatment and at 1 month, 3 months, 6 months and 12 months.
Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation
Time frame: 3 years
Safety Trial: The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v5.0 \> or = grade 3 Increase of \>=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL). This will be evaluated weekly during vancomycin use and RT, at 1 month post-vancomycin, 3 months post-vancomycin, 6 months post-vancomycin and 12 months post-vancomycin.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 14, 2026 · Source of record for eligibility and locations