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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

NCT01454934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2023-06-22

Study results available
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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.

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).

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-09
Primary Completion
2014-05-30
Completion
2016-05-02

Countries

  • United States
  • Australia
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454934 on ClinicalTrials.gov