NCT01282151

TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is: * A multicenter, prospective, randomized, phase 3 trial. * To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer. * 276 patients will be recruited.

Detailed description

Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.

Conditions

• Carcinoma, Non Small Cell Lung

Interventions

Type	Name	Description
DRUG	Taxotere	Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
DRUG	Pemetrexed	Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2011-01-24
• Last updated: 2015-07-14

Locations

15 sites across 1 country: South Korea