Evidence map›Paper›PMID 40356191›Full record

Trial reportThoracic cancer2025

Dysbiosis in the Gut Microbiome of Pembrolizumab-Treated Non-Small Lung Cancer Patients Compared to Healthy Controls Characterized Through Opportunistic Sampling.

Haris Charalambous, Cameron Brown, Paris Vogazianos, Kyriaki Katsaounou, Elpiniki Nikolaou, Ioannis Stylianou, Elisavet Papageorgiou, Dimitris Vraxnos, Aristos Aristodimou, Jianxiang Chi and 4 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Thoracic 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 NCT02705820 (A Phase II Study of Switch Maintenance Pembrolizumab in Patients With Non Small Cell Lung Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02705820 phase2completednot on this map

A Phase II Study of Switch Maintenance Pembrolizumab in Patients With Non Small Cell Lung Cancer (NSCLC) Who do Not Progress After First Line Platinum Doublet Chemotherapy. (SWIPE)

TypeinterventionalSponsorBank of Cyprus Oncology CentreRan2016 to 2023Enrolled48ConditionsMetastatic Non Small Cell Lung CancerArmsPembrolizumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
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

14 authors.

Haris CharalambousBank of Cyprus Oncology Centre, Nicosia, Cyprus.
Cameron BrownStremble Ventures Ltd, Limassol, Cyprus.
Paris VogazianosStremble Ventures Ltd, Limassol, Cyprus.
Kyriaki KatsaounouDepartment of Biological Sciences, University of Cyprus, Nicosia, Cyprus.
Elpiniki NikolaouAvva Pharmaceuticals Ltd, Limassol, Cyprus.
Ioannis StylianouBank of Cyprus Oncology Centre, Nicosia, Cyprus.
Elisavet PapageorgiouBank of Cyprus Oncology Centre, Nicosia, Cyprus.
Dimitris VraxnosStremble Ventures Ltd, Limassol, Cyprus.
Aristos AristodimouStremble Ventures Ltd, Limassol, Cyprus.
Jianxiang ChiKaraiskakio Foundation, Nicosia, Cyprus.
Paul CosteasKaraiskakio Foundation, Nicosia, Cyprus.
Christos ShammasAvva Pharmaceuticals Ltd, Limassol, Cyprus.
Yiorgos ApidianakisDepartment of Biological Sciences, University of Cyprus, Nicosia, Cyprus.
Athos AntoniadesStremble Ventures Ltd, Limassol, Cyprus.ORCID https://orcid.org/0000-0002-5789-5103

Funding

Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp
6 · The paper itself

Abstract

backgroundThe gut microbiome influences the host immune system, cancer development and progression, as well as the response to immunotherapy during cancer treatment. Here, we analyse the composition of the gut bacteriome in metastatic Non-Small Cell Lung Cancer (NSCLC) patients receiving Pembrolizumab immunotherapy within a prospective maintenance trial through opportunistic sampling during treatment.

methodsThe gut microbiome profiles of NSCLC patients were obtained from stool samples collected during Pembrolizumab treatment and analysed with 16S rRNA metagenomics sequencing. Patient profiles were compared to a group of healthy individuals of matching ethnic group, age, sex, BMI and comorbidities.

resultsA significant decrease in the treated patients was observed in two prominent bacterial families of the phylum Firmicutes, Lachnospiraceae and Ruminoccocaceae, which comprised 31.6% and 21.8% of the bacteriome in the healthy group but only 10.9% and 14.2% in the treated patient group, respectively. Species within the Lachnospiraceae and Ruminococcaceae families are known to break down undigested carbohydrates generating short chain fatty acids (SCFA), such as butyrate, acetate and propionate as their major fermentation end-products, which have been implicated in modifying host immune responses. In addition, a significant increase of the Bacteroidacaeae family (Bacteroidetes phylum) was observed from 10.7% in the healthy group to 23.3% in the treated patient group. Moreover, and in agreement with previous studies, a decrease in the Firmicutes to Bacteroidetes ratio in the metastatic NSCLC Pembrolizumab-treated patients was observed.

conclusionThe observed differences indicate dysbiosis and a compromised intestinal health status in the metastatic NSCLC Pembrolizumab-treated patients. This data could inform future studies of immunotherapy treatment responses and modulation of the gut microbiome to minimise dysbiosis prior or concurrent to treatment.

trial registrationSWIPE Trial (NCT02705820).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungDysbiosisGastrointestinal MicrobiomeLung NeoplasmsAgedCase-Control StudiesFemaleHumansMaleMiddle AgedPilot ProjectsProspective StudiesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumabgut dysbiosisgut microbiomeimmunotherapyLachnospiraceaepembrolizumabRumminoccocaceae

Identifiers

PMID40356191
PMCPMC12069221

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.