Japanese Study of Ipilimumab in Combination With Paclitaxel/Carboplati
Phase 1
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080221195
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Histologically or cytologically documented NSCLC who present with stage IIIB without indications for definitive radiotherapy or stage IV or recurrent
- No prior chemotherapy, hormonal therapy, immunotherapy and targeted therapy containing regimens for the treatment of NSCLC
Exclusion Criteria
- Symptomatic central nervous system (CNS) metastasis, or active CNS metastasis requiring medication.
- Malignant body cavity fluid (e.g. pleural effusion, cardiac effusion, ascites) that is recurrent despite appropriate supportive care.
- Autoimmune disease: subjects with a documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressant treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recommended dose of ipilimumab in combination with paclitaxel and carboplatin [ Time Frame: From Day 1 at 3rd cycle to Day 21 at 4th cycle ] [ Designated as safety issue: Yes ]<br>Same as current
- Secondary Outcome Measures
Name Time Method - Plasma PK: Summary stats tabulated for PK parameters (Cmax, AUC(0-21d), Tmax, & T-HALF) by ipilimumab dose.<br><br>- Tumor response: Individual tumor Best Overall Responses by RECIST criteria version 1.1 will be listed for each dose level<br>Same as current