Conditions: Non-Small Cell Lung Cancer
Keywords: comparative study of PF-00299804 and Erlotinib Double-Blind Phase 3 trial of TKI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 878
Healthy volunteers: no

Brief summary:
This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

Detailed description:

Arms:
arm 1: Blinded active PF-00299804 + blinded placebo comparator (erlotinib) arm 2: Blinded active comparator (erlotinib) + blinded placebo PF-00299804

Interventions: intervention 1: Dacomitinib (PF-00299804) intervention 2: Active Comparator (erlotinib) intervention 3: Placebo erlotinib intervention 4: Placebo PF00299804
Intervention descriptions: intervention 1: Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing intervention 2: Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing intervention 3: placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing. intervention 4: placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

Protocol document: