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

NCT ID: NCT03546829

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2028-12-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

125 mg, 4x daily for 5 weeks

Precision hypofractionated radiation

Intervention Type: 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.

Interventions

Vancomycin

125 mg, 4x daily for 5 weeks

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Feigenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ching Lai

Role: CONTACT

ching.lai@pennmedicine.upenn.edu

267-250-9244

RadOnc Clinical Research Unit

Role: CONTACT

radonccru@pennmedicine.upenn.edu

Facility Contacts

Ching Lai

Role: primary

ching.lai@pennmedicine.upenn.edu

267-250-9244

RadOnc Clinical Research Unit

Role: backup

radonccru@pennmedicine.upenn.edu

References

Feigenberg SJ, Costabile F, Tanes C, Bittinger K, O'Connor R, Agarwal D, Skoufos G, Salaris S, Hatzigeorgiou A, Kostopoulos N, Lloyd S, Friedes C, Chen L, Yegya-Raman N, Cengel K, Levin W, Valentic B, Quarton T, Shestov AA, Berman A, Bradley J, Maity A, Koumenis C, Ben-Josef E, Facciabene A. Enhancing outcomes in medically inoperable early-stage NSCLC with gut-targeted antibiotics and stereotactic body radiotherapy: results from a randomized pilot study. J Immunother Cancer. 2025 Jul 10;13(7):e011356. doi: 10.1136/jitc-2024-011356.

Reference Type: DERIVED

PMID: 40639850 (View on PubMed)

Other Identifiers

827551

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 08517

Identifier Type: -

Identifier Source: org_study_id