A phase III study of Platinum doublet chemotherapy with or without Nivolumab for the patients with chemo-naive, advanced non-small cell lung cancer (WJOG8615L)
Phase 3
- Conditions
- ung Cancer
- Registration Number
- JPRN-UMIN000021136
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 530
Inclusion Criteria
Not provided
Exclusion Criteria
1. Subjects with active, known or suspected autoimmune disease. 2. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization 3. Subjects with interstitial lung disease 4. Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival and progression-free survival
- Secondary Outcome Measures
Name Time Method Overall response rate, survival rate at two years, and safety