drugset / Trial / NCT00403403
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).
Timeline
- Start
- 2007-03
- Primary completion
- 2009-02
- Completion
- 2009-06
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo+Chemotherapy vs Bevacizumab+Chemotherapy; p = 0.0097; Hazard Ratio (HR) 0.528 (95% CI 0.323 to 0.862); Log Rank NCT00403403 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |