Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer T790M mutation. dacomitinib
Allocation: NON_RANDOMIZED | Intervention model: 
Enrollment: 41
Healthy volunteers: no

Brief summary:
This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.

Detailed description:

Arms:
arm 1: Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor. arm 2: Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations.

Interventions: intervention 1: Dacomitinib intervention 2: Dacomitinib
Intervention descriptions: intervention 1: Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg. intervention 2: Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.

Protocol document: