Conditions: Non-Small Cell Lung Cancer (NSCLC)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 540
Healthy volunteers: no

Brief summary:
This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Eribulin intervention 2: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
Intervention descriptions: intervention 1: Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days. intervention 2: * Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days
* Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days
* Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days
* Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only).

Protocol document: