Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC Eribulin Mesylate Erlotinib
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 123
Healthy volunteers: no

Brief summary:
This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: eribulin mesylate + erlotinib intervention 2: eribulin mesylate + erlotinib
Intervention descriptions: intervention 1: 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle. intervention 2: 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.

Protocol document: