Conditions: Non-Small Cell Lung Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m\^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses). arm 2: Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m\^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).

Interventions: intervention 1: Ipilimumab, 3 mg intervention 2: Ipilimumab, 10 mg intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Intervenous (IV) injection, administered every 3 weeks for up to 6 cycles intervention 2: IV injection, administered every 3 weeks for up to 6 cycles intervention 3: IV injection, 175 mg/m\^2, administered every 3 weeks for up to 6 cycles intervention 4: IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)

Protocol document: