CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 703 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) +1 moredrug
Likely dose
Sorafenib (Nexavar, BAY43-9006) 400 mgfrom 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/NCT00863746
NCT00863746Phase 3Completed
CompareCT.gov

A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease

Bayer·interventional·Posted Mar 18, 2009·Updated Jan 19, 2015

In Brief

A Phase 3 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) and Placebo for Carcinoma and Non-Small-Cell Lung. Completed, enrolled 703 participants across 182 sites in 34 countries.

Detailed Summary

The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesArgentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Netherlands, Pakistan, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2009
Enrollment StartApr 1, 2009
Primary CompletionMar 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.3 years ago

Interventions

Sorafenib (Nexavar, BAY43-9006)drug

Sorafenib 400 mg twice daily (BID)

Placebodrug

Placebo - 2 tablets twice daily (BID)