A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

December 9, 2011

Primary Completion Date

May 30, 2014

Study Completion Date

May 2, 2016

Conditions
Non-Small Cell Lung Cancer (NSCLC)
Interventions
DRUG

Eribulin

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.

DRUG

TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed

"* 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)."

Trial Locations (83)

Unknown

Los Angeles

Pleasant Hill

San Diego

Aurora

Washington D.C.

Port Saint Lucie

Decatur

Southfield

Lebanon

Lake Success

Portland

Spokane

Madison

Herston

Frankston

Strasbourg

Marseille

Marseille

Bordeaux

Toulouse

Limoges

Rennes

Saint-Herblain

Lille

Paris

Pierre-Bénite

Villejuif

Aschaffenburg

Gauting

Munich

Cologne

Essen

Recklinghausen

Mainz

Halle

Hong Kong

Lido di Camaiore

Monza

Aviano

Cremona

Milan

Siena

Nagoya

Kashiwa-shi

Fukuoka

Hiroshima

Sapporo

Kobe

Akashi-shi

Sendai

Nigata-shi

Kurashiki-shi

Habinko-shi

Osaka

Osakasayama-shi

Sunto-gun

Chūōku

Kōtoku

Ube-shi

Kitaadachi-gun

Gdansk

Mrozy

Otwock

Sczedin

Warsazawa

Barnaul

Novosibirsk

Saint Petersburg

Singapore

Seongnam-si

Suwon

Seoul

Sabadell

Terrassa

Pamplona

Barcelona

Madrid

Taichung

Tainan City

Taipei

London

Manchester

Sutton

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01454934 - A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter