Study of Microbiome to Predict Durvalumab Side Effects in Patients with Stage III Non-Small Cell Lung Cancer After Chemoradiation

What this Trial Is About

Researchers are evaluating whether examining the microbiome in people with stage III non-small cell lung cancer NSCLC who will receive the drug durvalumab after chemoradiation can help predict treatment side effects. This observational phase IV study aims to understand how the bacteria present in the body might relate to adverse reactions during durvalumab therapy. Before starting durvalumab treatment, participants will provide samples from three different sources to analyze their microbiome bacteria. The study will monitor participants receiving standard durvalumab care, tracking changes in their microbiome and bacterial metabolic pathways over up to 18 months, along with any severe side effects. Additional measures include time to treatment interruption due to adverse events and progression-free survival tracked up to 36 months. Participants will undergo regular visits and assessments, including collection of microbiome samples and monitoring of side effects and disease progression. Researchers will evaluate the occurrence of serious adverse events, microbiome changes, and treatment outcomes while participants remain under standard care. The study duration allows long-term observation of microbiome dynamics and treatment safety in this patient group.

Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients