Efficacy of anti-PD-L1 antibody in anti PD-1 antibody resistant non-small cell lung cancer
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-jRCTs031180055
- Lead Sponsor
- Horiike Atsushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 30
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 or cytologically confirmed non-small cell lung cancer
2)Anti-PD-1 antibody (nivolumab or pembrolizumab) resistant unresectable advanced or recurrent disease
3)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.
4)Measurable lesion by RECIST ver1.1
5)Previous therapy was terminated at least 14 days before
6)Age: Age at agreement acquisition is over 20years old
7)Performance status 0 to 2 (ECOG)
8)Life expectancy is at least 3 months
9)Adequate organ function, evidenced by following laboratory results within 14 days prior to starting study treatment
Absolute neutrophil count>=1,500/mm3
Platelet count>=100,000/mm3
Hemoglobin>=8.0g/dl
AST and ALT<2.5 times the upper limit of normal (ULN)
Total bilirubin<1.5 times the ULN
10)Persons who have the ability to consent, protect compliance matters during this study, have screening inspection prescribed in this study plan, and can complain about subjective symptoms.
11)After screening inspection prescribed in this study plan, persons who has been judged to be eligible for participation in this study by the research doctor
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, eye, blood disorder etc.)
2)History or complication of autoimmune disease
3)History of severe immune-related adverse events during anti PD-1 antibody therapy
4)Continuously using systemic corticosteroid
5)Symptomatic central nervous system of carcinomatous meningitis
6)Pericardial, pleural effusion or ascites to need drainage
7)Pregnant or lactating women, or men and women with wanting pregnancy
8)Severe hypersensitivity to medicine
9)Persons who has been judged unsuitable as subjects of this study by the research doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method