drugset / Trial / NCT00576914
Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
Phase 3
Unknown
1108 enrolled
Chinese Academy of Sciences
Beijing Chao Yang Hospital · collabChinese Academy of Medical Sciences · collabShanghai Jiao Tong University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-06
- Primary completion
- 2012-06
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Endostar | Protein / enzyme biologic | 7.5 mg/m2 | Intravenous |