NCT00766246

Phase II Avastin Trial for Stage IIIB/IV NSCLC

A Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second-Line Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Pharmatech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multicenter study in 160 patients in first line treatment and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).

Detailed description

This phase II clinical trial will address the issues of bevacizumab treatment duration and treatment safety as first-line therapy for patients with non-squamous NSCLC. Following disease progression or treatment failure, the potential benefit of continued bevacizumab therapy will be tested by randomizing patients to two treatment arms, including second-line chemotherapy with or without further bevacizumab. It is hypothesized that continuation of bevacizumab with pemetrexed as second-line treatment following progression will result in improved clinical outcomes for patients with NSCLC.

Conditions

• Non-small Cell Lung Cancer Stage IIIB
• Non-small Cell Lung Cancer Stage IV

Interventions

Type	Name	Description
DRUG	bevacizumab	15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line and maintenance
DRUG	docetaxel	75 mg/m2 administered in 21-day cycles on day 1 of each cycle for first line treatment
DRUG	carboplatin	AUC=6 administered in 21-day cycles on day 1 of each cycle for first-line treatment

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2008-10-03
• Last updated: 2016-04-19