Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer
Status:
Not yet recruiting
Trial end date:
2028-06-30
Target enrollment:
Participant gender:
Summary
Immunotherapy has recently become a main-stream treatment option in cancer care, with
improved clinical outcomes in many malignancies, especially that of lung cancer. The
long-term benefits of this treatment however are limited. There is therefore a critical need
to distinguish predictive biomarkers of response from those of resistance, and to develop
synergistic strategies for improved therapeutic response. Strong emerging evidence indicates
that the gut microbiome has the ability to influence response to immunotherapy. Unlike tumor
genomics, the gut microbiome is modifiable, and thus its modulation to enhance response to
immunotherapy is an attractive therapeutic strategy.
Working hypothesis: Fecal Microbiota Transplant (FMT) treatment in conjunction with standard
(chemo-)immunotherapy as a first-line treatment for metastatic lung cancer enhances disease
control rate.
The main objective of this study is to evaluate the safety and efficacy of Fecal Microbiota
Transplant (FMT) in altering response to immunotherapy in patients with metastatic lung
cancer. The overall goal is to determine microbiome compositional and gene-content changes in
patients who respond more efficiently to immunotherapy subsequent to FMT. This understanding
may lead to future microbiome-based treatments in combination with immunotherapy to
significantly increase lung cancer treatment efficacy. In this prospective clinical and
molecular study, we will perform an in-depth analysis of the potential role of FMT in the
context of immunotherapy.