articleNature MedicineJan 28, 2026HYBRID OA

Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial

SDSreya DuttaguptaMMMeriem MessaoudeneSHSebastian HunterADAntoine DesîletsRJRahima Jamal

Centre Hospitalier de l’Université de Montréal · Université de Montréal · +25 more institutions

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Abstract

Immune checkpoint inhibitors (ICI) have improved outcomes for patients with non-small cell lung cancer (NSCLC) and melanoma, yet over half of patients exhibit primary resistance. Fecal microbiota transplantation (FMT) may overcome resistance to anti-programmed cell death protein 1 (PD-1) therapy. The clinical activity and safety of FMT plus anti-PD-1 in NSCLC or anti-PD-1 plus anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) therapy in melanoma have not been evaluated. Here we report results from FMT-LUMINate, a multicenter, open-label, phase 2 trial assessing healthy donor FMT plus anti-PD-1 in NSCLC (n = 20) or anti-PD-1 plus anti-CTLA-4 (dual ICI) in melanoma (n = 20), in the first-line setting. Eligible…

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Topics & keywords

Topics
Keywords
  • Clinical endpoint
  • Microbiome
  • Immunotherapy
  • Adverse effect
  • Lung cancer
  • Clinical trial
  • Melanoma
  • Transplantation
UN Sustainable Development Goals
  • Good health and well-being
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