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Fecal microbiota transplantation (FMT), developed by the Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal for advanced non-small cell lung cancer (NSCLC), is a live biotherapeutic product administered via oral capsules. The therapy is being investigated in the MORELIA clinical trial (NCT04924374). The active component consists of fecal microbiota sourced from three healthy donors selected for an abundance of bacterial taxa that correlate with a positive response to immunotherapy. The treatment aims to modulate the patient's gut microbiome to enhance the efficacy of concurrent PD-1/PD-L1 checkpoint inhibitor immunotherapy. The trial enrolls patients with stage III/IV NSCLC who are naive to PD-1/PD-L1 inhibitors.
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