NCT01527864

Paclitaxel-Carboplatin Alone or With M2ES for Non-Small-Cell Lung Cancer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy of Paclitaxel-Carboplatin Alone or With Pegylated Endostatin for Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Protgen Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out. Patients were randomly assigned to the treatment (PC + pegylated endostatin) or the control group (PC+ placebo). The efficacy was evaluated every six weeks.Follow-up continued until disease progression or death.

Detailed description

A randomized phase 2 study, involving patients with advanced non-small-cell lung cancer who had not previously received chemotherapy, compared paclitaxel and carboplatin Plus placebo with paclitaxel and carboplatin plus PEGylated endostatin, with PEGylated endostatin at a dose of 10 mg/m2 intravenously every weeks.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	pegylated endostatin and Paclitaxel-Carboplatin	Dosage：10mg/m2
DRUG	Placebo and Paclitaxel-Carboplatin	Dosage：10mg/m2

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-12-01
• Completion: 2013-04-01
• First posted: 2012-02-07
• Last updated: 2012-02-07

Locations

1 site across 1 country: China