Japanese Study of Ipilimumab Administered in Combination With Paclitaxel/Carboplatin in Patients With Nonsmall-cell Lung Cancer

Phase 1 Study of Ipilimumab (BMS-734016) in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer

The primary purpose of this study was to establish the recommended dose of ipilimumab administered in combination with paclitaxel and carboplatin in Japanese patients with nonsmall-cell lung cancer.

Key Inclusion Criteria:

• Histologically or cytologically documented nonsmall-cell lung cancer (NSCLC) presenting as stage IIIB disease without indications for definitive radiotherapy, stage IV disease, or recurrent disease following radiation therapy or surgical resection
• No prior chemotherapy, hormonal therapy, immunotherapy, or targeted-therapy-containing regimens for the treatment of NSCLC
• Life expectancy of at least 3 months
• Eastern Cooperative Oncology Group performance score of 0-1
• Adequate bone marrow function
• Hemoglobin ≥9.0 g/dL
• Absolute neutrophil count ≥1,500/mm^3
• Platelet count ≥100,000/mm^3
• Adequate liver function
• Total bilirubin level ≤2.0*the upper limit of normal (ULN)
• Asparate aminotransferase level ≤2.5*ULN
• Alanine aminotransferase level ≤2.5*ULN
• Adequate renal function
• Calculated creatinine clearance based on Cockcroft and Gault formula ≥50 mL/min.

Key Exclusion Criteria:

• Symptomatic central nervous system (CNS) metastasis or active CNS metastasis requiring medication
• Malignant body cavity fluid (eg, pleural effusion, cardiac effusion, ascites) that recurred despite appropriate supportive care
• Prior radiation of ≥30% of major bone-marrow containing areas (pelvis, lumbar spine)
• Documented history of severe autoimmune or immune-mediated symptomatic disease that required prolonged (longer than 2 months) systemic immunosuppressant treatment
• Documented history of motor neuropathy considered of autoimmune origin (eg, Guillain Barré syndrome)
• Any concurrent malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, carcinoma of the mucous membrane of the gastrointestinal tract, or superficial bladder cancer treated with systemic therapy
• ≥Grade 2 diarrhea
• History of or concurrent disease of gastrointestinal tract perforations
• ≥Grade 2 peripheral neuropathy (motor or sensory)
• Uncontrolled intercurrent illness including infection requiring systemic therapy, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled angina pectoris, uncontrolled peptic ulcer, and cardiac arrhythmia requiring medication
• Positive finding for human immunodeficiency virus antibody, hepatitis B surface antigen, or hepatitis C virus antibody.