Table 3. Summary of active clinical trials of microbiome and NSCLC treatments.
| Clinical trial | Study title | Study type | Aims |
|---|---|---|---|
| NCT05502913 | Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer | Interventional, recruiting | Safety and efficacy of FMT treatment combined with first-line (chemo-)immunotherapy in metastatic lung cancer |
| NCT04680377 | Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients (Microdurva) | Observational, recruiting | Determine if examining the microbiome in non-small cell lung cancer participants who will receive durvalumab can predict treatment toxicity |
| NCT04107168 | Microbiome Immunotherapy Toxicity and Response Evaluation | Observational, recruiting | Saliva and a series of stool samples will be collected from patients with melanoma, renal or lung cancer receiving checkpoint inhibitors to analyse their microbiome and will be linked to treatment response |
| NCT05037825 | The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors | Observational, recruiting | Assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types |
| NCT04711330 | Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy | Observational, recruiting | The predictive value of the microbiome (throat swabs, stool and of bronchial samples) to identify patients who will relapse during durvalumab treatment after CRT (false negative rate) at 6 months |
| NCT03068663 | Microbiota and the Lung Cancer (MICA) | Interventional, recruiting | Study the composition of the microbiota from the lung, the upper airways and the gut, in patients who undergo surgical treatment or chemotherapy. These results will serve as a base for a future study, focused on manipulation of the microbiota by prebiotics, probiotics or synbiotics |
| NCT05303493 | Camu-Camu Prebiotic and Immune Checkpoint Inhibition in Patients With Non-small Cell Lung Cancer and Melanoma | Interventional, recruiting | Determine safety and tolerability and measure objective response rate in patients treated with checkpoint inhibitors and Camu Camu (prebiotic potential) |
| NCT04965129 | Supplementation of n-3 PUFA in the Modulation of Lean Mass in Patients With Lung Cancer Receiving a High-protein Diet | Interventional, recruiting | The purpose of this study is to assess the effects of fish oil supplementation in the modulation of lean mass and intestinal microbiome in patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and tyrosine kinase inhibitors receiving a high-protein diet |
| NCT04636775 | Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC) | Observational, recruiting | Determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers |
| NCT05037825 | The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors (PARADIGM) | Observational, recruiting | Large cohort design to assess the associations between the gut microbiota, host immune system, and ICB treatment efficacy across multiple cancer types |
| NCT05777603 | Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer | Interventional, recruiting | To test two inhaled antibiotics (aztreonam and vancomycin), combined with a standard cancer treatment, in people with NSCLC. Bacterial changes may aid in treatment efficacy |
| NCT05286294 | Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders (MITRIC) | Interventional, recruiting | Phase Iia study evaluating the safety, feasibility and efficacy of FMT to cancer patients not responding to ICB therapy, using ICB-responders as donors |
NSCLC, non-small cell lung cancer; ICI, immune-checkpoint inhibitor; CRT, chemo-radiotherapy; ICB, immune checkpoint blocker; FMT, fecal microbiota transplant.