Lead Investigator: Kazuki Takada, Saiseikai Fukuoka General Hospital, Fukuoka, Japan
Title of Proposal Research: Prognostic Impact of Probiotic Supplementation on the Outcomes in Patients with Advanced Non-Small Cell Lung Cancer Treated with First-Line Atezolizumab Pooled Analyses of Five Randomized Control Trials
Vivli Data Request: 9274
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
The lifetime risk of an individual developing lung cancer is approximately 1 in 15 to 17, making lung cancer a leading cause of cancer-related deaths. Non-small cell lung cancer (NSCLC) is the most prevalent type, accounting for 85% of all lung cancer cases. Despite advancements in immunotherapy, which is a type of cancer treatment using the patient’s own immune system to fight cancer cells, particularly with immune checkpoint inhibitors that assist the body in recognizing and attacking cancer cells, treatment outcomes for NSCLC remain suboptimal. Therefore, there is a pressing need to explore novel approaches that can enhance the efficacy of immunotherapy and improve patient outcomes.
Gut microbiota or microbiome is the system of microorganisms in a person’s gastrointestinal system. This includes many bacteria, fungi, viruses, and other organisms. The composition of gut microbiota has been linked to the response to immunotherapy. Dysbiosis, a condition characterized by an imbalance between the good and bad bacteria in our intestines, and other disruptions in the gut microbiome have been associated with reduced response rates to immunotherapy in various cancers, including NSCLC.
Probiotics are live bacteria and yeasts promoted as having various health benefits. They’re usually added to yoghurts or taken as food supplements, and are often described as “good” or “friendly” bacteria. Probiotics, which promote gut health, may have a positive influence on the tumor immune microenvironment and enhance the response to immunotherapy. However, solid evidence from prospective clinical trials is lacking, and the clinical significance of probiotics in patients with advanced NSCLC receiving
first-line cancer immunotherapy is poorly understood.
The objective of this study is to investigate the prognostic impact of probiotic supplementation on the outcomes in patients with advanced NSCLC treated with first-line atezolizumab (one of the immune checkpoint inhibitors that stop tumors from evading white blood cells and stimulate an immune response against the tumor cells). Probiotic supplementation means taking products like BIOFERMIN, LAC-B and MIYA-BM, which contain good bacteria such as Bifidobacterium and Clostridium bacterium that keep the digestive system healthy.
Requested Studies:
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367794
Sponsor ID: GO29437
A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367781
Sponsor ID: GO29537
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02366143
Sponsor ID: GO29436
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02657434
Sponsor ID: GO29438
A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02409342
Sponsor ID: GO29431