Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
- Conditions
- on-Small-Cell Lung Cancer
- Registration Number
- JPRN-UMIN000026375
- Lead Sponsor
- Kansai Clinical Oncology Group
- Brief Summary
???Primary 1. Relationship between DCR and gut microbiota. : No significant difference was observed in all bacterial species. 2. Relationship between ORR and gut microbiota.: Clostridium subcluster XIVa showed a significant correlation (HR:1.146, 95% C.I.:1.025-1.282, p=0.0165). But no significant difference was found in other species. ???Secondary Relationship between ORR and changes in gut microbiota.: No significant difference was observed in all bacterial species.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
Not provided
1)With active or history of Interstitial pneumonia. 2)Interstitial change or pulmonary fibrosis detectable on X ray 3)Autoimmune disease. 4)Patients receiving corticosteroids (up to 10 mg/day in terms of prednisolone is acceptable) or immunosuppressants within 2 weeks before registration. 5)Patients receiving antibiotics within 5 weeks before registration 6)Patients who are pregnant or nursing 7)With active or history of inflammatory bowel disease. 8)Evaluated to be ineligible by a physician for other reasons.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.
- Secondary Outcome Measures
Name Time Method Relationship between variation of bacterial flora and therapeutic effect, AEs or PD-L1 expression.