CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 904 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) +3 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/NCT00449033
NCT00449033Phase 3Completed
CompareCT.gov

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

Bayer·interventional·Posted Mar 19, 2007·Updated Apr 23, 2015

In Brief

A Phase 3 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006), Placebo, and 2 other interventions for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 904 participants across 122 sites in 18 countries.

Detailed Summary

Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesAustria, Belgium, Brazil, Canada, China, Cyprus, Finland, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2007
Enrollment StartFeb 1, 2007
Primary CompletionApr 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.3 years ago

Interventions

Sorafenib (Nexavar, BAY43-9006)drug

Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV

Placebodrug

Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV

Gemcitabinedrug

Chemotherapy component; Gemcitabine 1250 mg/m\^2 IV

Cisplatindrug

Chemotherapy component; Cisplatin 75 mg/m\^2 IV