drugset / Trial / NCT00620971
Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC
Phase 2
Completed
77 enrolled
Hellenic Oncology Research Group
University Hospital of Crete · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial will evaluate whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival advantage in patients with locally advanced or metastatic NSCLC.
Timeline
- Start
- 2008-01
- Primary completion
- 2010-04
- Completion
- 2010-04
Outcome
Missed primary endpoint
paper The study did not meet its primary endpoint since, the ORR was 39.5% PMID 25662596 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1100 mg/m2 | Intravenous |
| Subject | Vinorelbine | Small molecule | 60 mg/m2 | Oral |