Conditions: Non-small Cell Lung Cancer With EGFR-Activating Mutations
Keywords: first-line locally advanced or metastatic non-small cell lung cancer epidermal growth factor receptor EGFR ARCHER mutation dacomitinib PF-00299804
Allocation: RANDOMIZED | Intervention model: 
Enrollment: 452
Healthy volunteers: no

Brief summary:
This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

Detailed description:
452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.

Arms:
arm 1: Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing. arm 2: Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.

Interventions: intervention 1: Dacomitinib (PF-00299804) intervention 2: Gefitinib
Intervention descriptions: intervention 1: Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing. intervention 2: Gefitinib 250 mg tablets, continuous oral daily dosing.

Protocol document: