76TiP Fecal microbiota transplantation to improve efficacy of immune checkpoint inhibitors in metastatic lung cancer

Immunotherapy has recently become a main-stream treatment option in cancer care, with improved clinical outcomes many malignancies, especially that of lung cancer. The long-term benefits this however are limited. Thus, there is critical need to distinguish predictive biomarkers response from those resistance, and develop synergistic strategies for therapeutic response. Strong emerging evidence indicates the gut microbiome ability influence immunotherapy. Unlike tumor genomics, modifiable, thus, its modulation enhance immunotherapy an attractive strategy. main objective study evaluate safety efficacy Fecal Microbiota Transplant (FMT) altering patients metastatic overall goal determine compositional gene-content changes who respond more efficiently subsequent FMT. This understanding may lead future microbiome-based treatments combined significantly increase treatment. In prospective clinical-and molecular study, we will perform in-depth analysis potential role FMT context prospective, stratified, randomized, placebo-controlled, double-blinded, comparative study. assess feasibility transplant when used conjunction standard +/- chemotherapy as first-line disease control rate. Completely serve fecal implant donors. Patients start receiving placebo/antibiotics then receive placebo/FMT on first day (chemo-)immunotherapy cycle 1 every 3 weeks. capsules administrations be repeated until End Treatment. NCT05502913. I. Massalha.