Impact of Bifidobacterium Lactis Probiotic on Survival and Treatment Response in Adults with Metastatic Non-small Cell Lung Cancer Receiving Nivolumab Immunotherapy

What this Trial Is About

Researchers are evaluating the impact of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer mNSCLC. This study focuses on patients receiving immunotherapy with nivolumab and aims to explore how gut microbiota influences treatment response, survival, and side effects. The study is particularly interested in identifying microbiota biomarkers specific to Turkish cancer patients to support personalized treatment approaches. Participants are randomly assigned to one of two groups. The intervention group receives an oral dose of 4 x 109 cfugday of Bifidobacterium animalis subsp. lactis BL-04 alongside standard immunotherapy with nivolumab administered intravenously every two weeks for twelve weeks. The placebo group receives nivolumab with a daily maltodextrin sachet instead of the probiotic. Both groups follow this 12-week immunotherapy and supplementation schedule. During the study, participants undergo evaluations of clinical response, progression-free survival, and overall survival, with measurements taken at baseline and after 12 weeks. Researchers also assess changes in intestinal microbiota and immune system markers. Safety is monitored throughout the treatment period. The total participation duration spans the treatment period with follow-up on clinical outcomes. This information may help develop probiotic supplements as complementary therapies for mNSCLC treatment.

The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients