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Design paper: A phase II study of Bevacizumab and Erlotinib in patients with non-Squamous non-small cell lung cancer that is refractory or relapsed after 1-2 previous Treatment (BEST)
- Source :
- Trials, Trials, Vol 12, Iss 1, p 120 (2011)
- Publication Year :
- 2011
- Publisher :
- Springer Science and Business Media LLC, 2011.
-
Abstract
- Background Combination of erlotinib and bevacizumab is a promising regimen in advanced non-squamous non-small-cell lung cancer (NSCLC). We are conducting a single arm phase II trial which aims to evaluate the efficacy and safety of this regime as a second- or third-line chemotherapy. Methods Key eligibility criteria were histologically or cytologically confirmed non-squamous NSCLC, stage III/IV or recurrent NSCLC not indicated radical chemoradiation, prior one or two regimen of chemotherapy, age 20 years or more, and performance status of two or less. The primary endpoint is objective response rate. The secondary endpoints include overall survival, progression-free survival, disease control rate and incidence of adverse events. This trial plans to accrue 80 patients based on a two-stage design employing a binomial distribution with an alternative hypothesis response rate of 35% and a null hypothesis threshold response rate of 20%. A subset analysis according to EGFR mutation status is planned. Discussion We have presented the design of a single arm phase II trial to evaluate the efficacy and safety of combination of bevacizumab and erlotinib in advanced non-squamous NSCLC patients. In particular we are interested in determining the merit of further development of this regimen and whether prospective patient selection using EGFR gene is necessary in future trials. Trial registration This trial was registered at the UMIN Clinical Trials Registry as UMIN000004255 (http://www.umin.ac.jp/ctr/index.htm).
- Subjects :
- Adult
Oncology
medicine.medical_specialty
Pathology
Lung Neoplasms
Time Factors
Bevacizumab
Medicine (miscellaneous)
Angiogenesis Inhibitors
Antibodies, Monoclonal, Humanized
Disease-Free Survival
Erlotinib Hydrochloride
Young Adult
Study Protocol
Japan
Carcinoma, Non-Small-Cell Lung
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Clinical endpoint
Humans
Pharmacology (medical)
Lung cancer
Protein Kinase Inhibitors
Survival rate
Survival analysis
Neoplasm Staging
Salvage Therapy
lcsh:R5-920
Performance status
business.industry
Antibodies, Monoclonal
medicine.disease
Survival Analysis
ErbB Receptors
Survival Rate
Regimen
Treatment Outcome
Drug Resistance, Neoplasm
Research Design
Mutation
Quinazolines
Erlotinib
Neoplasm Recurrence, Local
lcsh:Medicine (General)
business
medicine.drug
Subjects
Details
- ISSN :
- 17456215
- Volume :
- 12
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....050cea76ad73edeec0fd69c50483e7d5