Evidence map›Paper›PMID 40639850›Full record

Trial reportJournal for immunotherapy of cancer2025

Enhancing outcomes in medically inoperable early-stage NSCLC with gut-targeted antibiotics and stereotactic body radiotherapy: results from a randomized pilot study.

Steven Joel Feigenberg, Francesca Costabile, Ceylan Tanes, Kyle Bittinger, Roderick O'Connor, Divyansh Agarwal, Giorgos Skoufos, Silavano Salaris, Artemis Hatzigeorgiou, Nektarios Kostopoulos and 15 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03546829 (Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03546829 phase1recruitingnot on this map

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

TypeinterventionalSponsorAbramson Cancer Center at Penn MedicineRan2019 to 2028Enrolled10ConditionsEarly Stage Non-Small Cell Lung CancerArmsVancomycin, Precision hypofractionated radiation
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Steven Joel FeigenbergRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Francesca CostabileRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Ceylan TanesCHOP, Philadelphia, Pennsylvania, USA.
Kyle BittingerCHOP, Philadelphia, Pennsylvania, USA.
Roderick O'ConnorUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Divyansh AgarwalMGH, Boston, Massachusetts, USA.
Giorgos SkoufosUniversity of Thessaly, Volos, Greece.
Silavano SalarisIstituto Zooprofilattico Sperimentale delle Venezie, Legnaro, Italy.
Artemis HatzigeorgiouUniversity of Thessaly, Volos, Greece.
Nektarios KostopoulosRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Shane LloydDepartment of Radiation Oncology, University of Utah Health Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Cole FriedesRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Lisha ChenRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Nikhil Yegya-RamanRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Keith CengelRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
William LevinRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Bakir ValentićUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.ORCID http://orcid.org/0009-0007-5253-0010
Tyler QuartonKBR Inc., Intelligent Systems Division, NASA Ames Research Center, Moffett Field, California, USA.
Alexander A ShestovUniversity of Pennsylvania, Philadelphia, Pennsylvania, USA.
Abigail BermanFox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
Jeffrey BradleyRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Amit MaityDepartment of Radiation Oncology, University of Utah Health Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Costantinos KoumenisRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Edgar Ben-JosefRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Andrea FacciabeneRadiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA Andrea.Facciabene@pennmedicine.upenn.edu.ORCID http://orcid.org/0000-0002-9563-297X

Funding

(PQ10) The impact of the gut microbiome on the anti-tumor effects of radiotherapyR01CA219871 · NCI · UNIVERSITY OF PENNSYLVANIA · PI FACCIABENE, ANDREA, KOUMENIS, CONSTANTINOS · 2018 to 2022
$2.4M
NCI NIH HHS R01 CA219871
6 · The paper itself

Abstract

backgroundGut microbiota modulation is an emerging strategy to improve cancer therapy outcomes. This study evaluated the safety and therapeutic potential of combining oral vancomycin-a non-absorbed, gut-restricted antibiotic with primary activity against gram-positive bacteria-with stereotactic body radiotherapy (SBRT) in early-stage non-small cell lung cancer (NSCLC). The underlying hypothesis was that vancomycin-induced changes in gut microbiota could enhance the antitumor effects of SBRT.

methodsWe conducted a randomized, open-label pilot study in patients with early-stage NSCLC. Patients received oral vancomycin (125 mg, four times daily for 5 weeks, starting 1 week prior to SBRT). Safety, progression-free survival (PFS), overall survival (OS), gut microbiota composition, gut metabolome, and immune responses were evaluated.

resultsThe combination of vancomycin and SBRT was well tolerated, with no grade 3 or 4 adverse events reported. Vancomycin treatment selectively depleted certain bacterial strains while enriching others, leading to significant restructuring of the gut microbiota and alterations in the gut metabolome, including reductions in short-chain fatty acids and shifts in other important immunomodulatory metabolites. These changes were associated with dendritic cell and T cell activation, suggesting enhanced systemic immune engagement. Patients receiving vancomycin showed improved outcomes, with a PFS HR of 0.42 (95% CI 0.18 to 0.96; p=0.049) and OS HR of 0.38 (95% CI 0.14 to 0.99; p=0.033), compared with controls.

conclusionsThis pilot study demonstrates that gut microbiome modulation using a gram-positive-targeting, gut-restricted antibiotic in combination with SBRT is safe and may improve clinical outcomes in early-stage NSCLC. These findings support further investigation of targeted microbiome modulation strategies as adjuvants to immunogenic therapies like radiation. TRIAL REGISTRATION NUMBER: NCT03546829.

Indexed as

Anti-Bacterial AgentsCarcinoma, Non-Small-Cell LungGastrointestinal MicrobiomeLung NeoplasmsRadiosurgeryVancomycinAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm StagingPilot ProjectsTreatment OutcomeAnti-Bacterial AgentsVancomycinAbscopalDendriticLung CancerRadiotherapy/radioimmunotherapy

Identifiers

PMID40639850
PMCPMC12258320

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.