Conditions: Recurrent Non Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 120
Healthy volunteers: no

Brief summary:
This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: apricoxib/erlotinib intervention 2: erlotinib/placebo
Intervention descriptions: intervention 1: apricoxib: 100 mg tablets, 400mg/day

erlotinib: per package insert intervention 2: erlotinib: per package insert

placebo: 100 mg tablets, 400 mg/day

Protocol document: