Non-squamous Non-small cell lung cancer Non-squamous Non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: We determine patients who are obtained document agreement by free will after the explanation using informed consent form, satisfy all of the following selection criteria, do not conflict with exclusion criteria, have been judged to be eligible for participation in this study by the research doctor as subjects. 1)Histologically confirmed non-squamous non-small cell lung cancer 2)Patients with unknown driver mutation, or without a driver mutation in the EGFR, ALK, ROS1, or BRAF are eligible. Patients with a driver mutation in the EGFR, ALK, ROS1, or BRAF must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more kinase inhibitors. 3)Measurable lesion by RECIST ver1.1 4)Age: Age at agreement acquisition is over 20years old 5)Performance status 0 to 1 (ECOG) 6)Life expectancy is at least 3 months 7)Adequate organ function
Exclusion criteria
Exclusion criteria: We exclude persons who corresponding to any of the following criteria from this study. 1)Medical history that may have an impact on the evaluation and safety of this study (heart, liver, kidney, lung, blood disorder etc.) 2)History or complication of autoimmune disease 3)Continuously using systemic corticosteroid 4)Pericardial, pleural effusion or ascites to need drainage 5)Pregnant or lactating women, or men and women with wanting pregnancy 6)Persons who has been judged unsuitable as subjects of this study by the research doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of progression-free survival at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of objective response Progression-free survival Overall survival Adverse events Relationship between rate of progression-free survival at 6 months, rate of objective response , progression-free survival and Microbiota. | — |
Contacts
Showa University Hospital