Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma

Official Title

Phase II Trial of Fecal Microbial Transplantation in Patients With Advanced Non-Small Cell Lung Cancer and Melanoma Treated With Immune Checkpoint Inhibitors.


The aim of this study is to assess the anti-tumour activity of FMT administered in combination with ICI therapy.

Trial Description

Primary Outcome:

  • Objective response rate in the NSCLC cohort by RECIST criteria.
Secondary Outcome:
  • Progression-free survival at 1 year in the NSCLC cohort by RECIST criteria.
  • Overall survival at 1 year in the NSCLC cohort assessed by RECIST criteria.
  • Incidence of treatment-related adverse events (Safety and tolerability)
  • Incidence of treatment-related laboratory test abdnomarlities (Safety and tolerability)
Immune-checkpoint inhibitors (ICI) now represent the backbone therapy for patients with advanced or unresectable non-small cell lung cancer (NSCLC) and melanoma. With the use of anti-PD-1 (Pembrolizumab), overall survival (OS) is now 45% at two years for patients with metastatic NSCLC with a PD-L1 expression level above 50%. The OS for patients with metastatic melanoma is now 52% at five years with combination therapy of anti-CLTA-4 (Ipilimumab) and anti-PD-1 (Nivolumab). However, only a minority of patients obtain durable responses and current biomarkers are unable to consistently and accurately predict response to ICI. Addressing these unmet needs, the gut microbiome has emerged as a potential biomarker of response to ICI. Modulating the gut microbiome to improve response to ICI is an active area of study. One way to modify the gut microbiome composition is through fecal microbial transplantation (FMT) and pre-clinical studies showed improved effectiveness of ICI when mice received FMT from lung cancer patients responding to ICI. Recently, 2 phase I clinical studies published in Science consolidated these findings, and demonstrated the safety of FMT in patients with melanoma treated with ICI. Building on phase I studies showing that FMT is safe in patients with cancer receiving ICI, and compelling data demonstrating the potential of FMT to reverse ICI resistance, there is a strong rationale to further study the role of FMT in improving ICI efficacy in patients with melanoma and NSCLC treated with ICI in the first-line setting in a phase II study. Our primary objective is to assess the impact of FMT on ICI response and survival. Other goals of this trial are to study the changes in the patient's gut microbiome composition and tumour microenvironment contexture following the combination treatment of ICI and FMT. Efficacy of FMT in terms of response rate and overall survival in patients with metastatic melanoma and uveal melanoma will be studies as part of an exploratory endpoint.

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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