About this trial
This study aims to investigate the efficacy and safety of fecal microbiota transplantation (FMT) as a treatment for non-small cell lung cancer (NSCLC) patients whose disease has progressed after immune checkpoint inhibitor (ICI) therapy, and to establish the foundation for personalized FMT through gut microbiome analysis.
Recovering immune responses in patients who have failed prior immunotherapy remains an unmet clinical need. This study aims to provide evidence to address this issue. Fecal microbiota transplantation (FMT) is a means that can rapidly and efficiently change the intestinal microbiota and has the potential to affect the systemic immune environment. Therefore, this study intends to contribute to the development of future treatment strategies by evaluating whether FMT can restore the immune response and clinical efficacy in patients with immune checkpoint inhibitor-resistant NSCLC.
Eligibility criteria
Qualifiers
DONOR
Patients with histologically confirmed NSCLC who have maintained a clinical benefit(partial response, PR) for more than 1 year through immune checkpoint inhibitor therapy
Healthy volunteers with no history of inflammatory bowel disease ④ Subjects who agree to provide repetitive blood and fecal samples during the trial period
RECIPIENT
Disqualifiers
DONOR
Have voluntarily provided written Informed consent to participate in this clinical trial
Adults aged 19 years or older
Histologically or cytologically confirmed progressive or metastatic NSCLC
Trial design
Treatments tested in this trial
- Tislelizumab
- Fecal Microbiota Transplant(FMT)
Treatment groups
Locations
Sponsors and collaborators
Se-Hoon Lee
Lead sponsor
Samsung Medical Center
Sponsor institution