NCT01244191

Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,048 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

Conditions

• Non Squamous, Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tivantinib	Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day
DRUG	Placebo	Tivantinib Placebo tablets given twice a day
DRUG	Erlotinib	Erlotinib 150 mg oral tablets, given once a day

Timeline

• Start date: 2011-01-11
• Primary completion: 2012-12-15
• Completion: 2012-12-15
• First posted: 2010-11-19
• Last updated: 2021-04-06
• Results posted: 2020-10-30

Locations

304 sites across 23 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Netherlands, Peru, Poland, Romania, Russia, Spain, Sweden, United Kingdom