Phase II trial of anti-PD-1 therapy after anti-PD-L1 therapy in patients with unresectable locally advanced or advanced non-small-cell lung cancer
- Conditions
- non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000040696
- Lead Sponsor
- ational cancer center hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 75
Not provided
Subjects with an active infection requiring systemic treatment. History of the treatment of anti PD-L1, anti-CTLA-4 antibody or drugs of effect to T cell. Subjects with an active Gastrointestinal ulcer. Subjects with past or present history of interstitial lung disease diagnosed by clinical or imaging findings. History of allergy or hypersensitivity to study drug components. Subjects with an active or refractory autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Known history of testing positive for HIV antibody, HBs antigen, HCV antibody and HCV-RNA. If HBs antibody or HBc antibody was positive, subjects testing negative for HBV-DNA is permitted to enroll. Subjects who are or may be pregnant, or are breast-feeding. Subjects with psychiatric illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method