CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,314 enrolled
Drug / intervention
placebo plus docetaxel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00805194
NCT00805194Phase 3Completed
CompareCT.gov

Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

Boehringer Ingelheim·interventional·Posted Dec 9, 2008·Updated Dec 5, 2018

In Brief

A Phase 3 clinical trial evaluating placebo plus docetaxel and BIBF 1120 plus docetaxel for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 1,314 participants across 210 sites in 27 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesAustria, 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
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2008
Enrollment StartDec 3, 2008
Primary CompletionNov 2, 2010
Study CompletionNov 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.6 years ago

Interventions

placebo plus docetaxeldrug

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

BIBF 1120 plus docetaxeldrug

BIBF 1120 2 times daily along with standard therapy of docetaxel