Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer
Trial Parameters
Brief Summary
Immunotherapy has recently become a main-stream treatment option in cancer care, with improved clinical outcomes in many malignancies, especially that of lung cancer. The long-term benefits of this treatment however are limited. There is therefore a critical need to distinguish predictive biomarkers of response from those of resistance, and to develop synergistic strategies for improved therapeutic response. Strong emerging evidence indicates that the gut microbiome has the ability to influence response to immunotherapy. Unlike tumor genomics, the gut microbiome is modifiable, and thus its modulation to enhance response to immunotherapy is an attractive therapeutic strategy. Working hypothesis: Fecal Microbiota Transplant (FMT) treatment in conjunction with standard (chemo-)immunotherapy as a first-line treatment for metastatic lung cancer enhances disease control rate. The main objective of this study is to evaluate the safety and efficacy of Fecal Microbiota Transplant (FMT) in altering response to immunotherapy in patients with metastatic lung cancer. The overall goal is to determine microbiome compositional and gene-content changes in patients who respond more efficiently to immunotherapy subsequent to FMT. This understanding may lead to future microbiome-based treatments in combination with immunotherapy to significantly increase lung cancer treatment efficacy. In this prospective clinical and molecular study, we will perform an in-depth analysis of the potential role of FMT in the context of immunotherapy.
Eligibility Criteria
Patient (Recipient) Inclusion Criteria: 1. A histologically confirmed diagnosis of malignancy. 2. Patients over the age of 18. 3. Patients planning to be treated with chemotherapy, immune checkpoint inhibitors and/or targeted therapy. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 5. Able to provide written informed consent. Patient (Recipient) Exclusion Criteria: 1. Severe or life-threatening food allergy (e.g. nuts, seafood) 2. Allergy or other contraindication to omeprazole, investigational medicinal product. 3. Treatment with pre- or probiotics in the four weeks prior to randomization. 4. Severe immunodeficiency: * Systemic chemotherapy \<30 days from baseline * Known neutropenia with absolute neutrophils \<1.0x109 cells/µL * Prolonged treatment with corticosteroids (equivalent to prednisone \>60mg daily for \>30 days) within 8 weeks of randomization 5. Swallowing disorder, oral-motor discoordination, inability to swallow capsules 6. Pregnant or breastfeeding o