Japanese Study of Ipilimumab Administered in Combination With Paclitaxel/Carboplatin in Patients With Nonsmall-cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ipilimumab, 3 mg; Ipilimumab, 10 mg; Paclitaxel; Carboplatin
Intervention description: Intervenous (IV) injection, administered every 3 weeks for up to 6 cycles; IV injection, administered every 3 weeks for up to 6 cycles; IV injection, 175 mg/m^2, administered every 3 weeks for up to 6 cycles; IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)
Intervention MeSH terms: Paclitaxel; Carboplatin; Ipilimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.