At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 954 enrolled
Drug / intervention
Lenvatinib +1 moredrug
Likely dose
Lenvatinib 12 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.
A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma
In Brief
A Phase 3 clinical trial evaluating Lenvatinib and Sorafenib for Hepatocellular Carcinoma (HCC). Completed, enrolled 954 participants across 186 sites in 21 countries.
Detailed Summary
E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma (HCC)
CountriesAustralia, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Philippines, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartMar 2013
Primary CompletionNov 2016
Study CompletionMar 2021
TodayJul 2026
First PostedJan 4, 2013
Enrollment StartMar 1, 2013
Primary CompletionNov 13, 2016
Study CompletionMar 10, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.5 years ago
Interventions
Lenvatinibdrug
12 mg (or 8 mg) once daily (QD) oral dosing.
Sorafenibdrug
400 mg twice daily (BID) oral dosing.