drugset / Trial / NCT00806923
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
RandomizedParallel-groupOpen-labelTreatment
Summary
This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.
Timeline
- Start
- 2005-02
- Primary completion
- 2011-02
- Completion
- 2011-02
Outcome
Met primary endpoint
paper Significant PFS prolongation with bevacizumab compared with placebo was maintained with longer follow-up PMID 20150572 ↗
paper 0.75 (0.64-0.87), P = 0.0003 and 0.85 (0.73-1.00), P = 0.0456 PMID 20150572 ↗
Publications
- Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.
- Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.
- Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1250 mg/m2 | — |