2024 World Conference on Lung Cancer (WCLC) - Posters-P4.11D.06 A Phase II Trial of Restorative Microbiota Therapy with Chemoimmunotherapy in Metastatic Non-Small Cell Lung Cancer

P4.11D.06 A Phase II Trial of Restorative Microbiota Therapy with Chemoimmunotherapy in Metastatic Non-Small Cell Lung Cancer

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This document describes a Phase II clinical trial investigating the use of Restorative Microbiota Therapy (RMT) in combination with chemoimmunotherapy for patients with advanced or metastatic non-small cell lung cancer (NSCLC). Current treatments for NSCLC primarily involve immune checkpoint inhibitors (ICI), often combined with platinum-based chemotherapy. These treatments have demonstrated success, but many patients do not respond or develop resistance. Recent research indicates that the gut microbiome may influence the effectiveness of immunotherapy in treating lung cancer and metastatic melanoma.<br /><br />The trial is evaluating whether using fecal microbiota transplants, termed Restorative Microbiota Therapy, could enhance treatment outcomes by restoring gut microbiome diversity, potentially overcoming resistance to ICIs. The trial's co-primary objectives are to assess the safety, feasibility, and efficacy of RMT alongside durvalumab, tremelimumab, and chemotherapy, with a focus on progression-free survival. Secondary goals include determining the objective response rate, duration of response, overall survival, and rates of immune-mediated adverse events. It also aims to assess health-related quality of life in patients through specific quality of life questionnaires.<br /><br />The study, identified as NCT04105270, is a multicenter, randomized, double-blind trial, administered by multiple investigators and sponsored by AstraZeneca. The RMT involves an oral formulation of freeze-dried fecal microbiota sourced from healthy individuals, manufactured at the University of Minnesota. Patients will undergo CT scans every 6 to 8 weeks to monitor disease progression. The trial supports the burgeoning evidence that microbiome manipulation may hold potential for improving cancer treatment outcomes.

Asset Subtitle

Amit Kulkarni

Meta Tag

Speaker Amit Kulkarni

Topic Metastatic NSCLC – Immunotherapy

Keywords

Restorative Microbiota Therapy

non-small cell lung cancer

chemoimmunotherapy

immune checkpoint inhibitors

fecal microbiota transplants

gut microbiome

durvalumab

tremelimumab

clinical trial

AstraZeneca