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LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer

NCT00805194 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1314

Last updated 2018-12-05

Study results available
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Summary

The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

placebo plus docetaxel

placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel

DRUG

BIBF 1120 plus docetaxel

BIBF 1120 2 times daily along with standard therapy of docetaxel

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-03
Primary Completion
2010-11-02
Completion
2017-11-13

Countries

  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • China
  • Croatia
  • Czechia
  • Denmark
  • France
  • Georgia
  • Germany
  • Greece
  • India
  • Israel
  • Italy
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00805194 on ClinicalTrials.gov