Conditions: NSCLC (Non-small Cell Lung Carcinoma)
Keywords: Non small cell lung cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 76
Healthy volunteers: no

Brief summary:
The purpose of this study was to determine if ruxolitinib, in combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.

Detailed description:
The study consisted of an open-label, safety run-in (consisting of 1 to 4 cohorts of 9 participants each), to confirm the safety of ruxolitinib in combination with pemetrexed/cisplatin in participants with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent. Participants in the safety run-in received open-label ruxolitinib and pemetrexed and cisplatin.

In the second part of the study, participants enrolled and randomized and received pemetrexed and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of ruxolitinib administered was determined from the data produced in the safety run-in phase.

Treatment consisted of repeating 21-day cycles. Participants received infusions of pemetrexed and cisplatin on Day 1 of each cycle and ruxolitinib/placebo was self-administered during the entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed, based on the original treatment assignment, was allowed for participants eligible for maintenance therapy.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ruxolitinib intervention 2: Placebo intervention 3: Pemetrexed intervention 4: Cisplatin
Intervention descriptions: intervention 1: 5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID)) intervention 2: 5 mg matching placebo tablets to be administered by mouth intervention 3: 500 mg/m\^2 administered as an intravenous infusion over 10 minutes intervention 4: 75 mg/m\^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion

Protocol document: