NCT00576914

Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

Adjuvant Vinorelbine Plus Cisplatin Versus Vinorelbine Plus Cisplatin Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer (Phase III Study, Randomized, Open, Multi-center)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,108 (estimated)
• Sponsor: Chinese Academy of Sciences · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer. The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.

Detailed description

It is an open labelled, randomized, multi-center phase III clinical trail.A total of 1108 patients with resected stage IB to stage IIIA non-small cell lung cancer will either ether the group of vinorelbine plus cisplatin plus endostar or the group of vinorelbine plus cisplatin randomly. The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.The major inclusive criteria are pathological confirmed non-small cell lung cancer after complete resection and can tolerate chemotherapy safely.The tissue and blood samples will be banked for further investigation. All of the enrolled patients will be followed up until death or over 5 years.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	recombinant human endostatin	recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2007-12-19
• Last updated: 2010-03-09

Locations

1 site across 1 country: China