A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.
NCT00700180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 303
Last updated 2014-09-25
Summary
This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Conditions
Interventions
- DRUG
-
bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle
- DRUG
-
bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle
- DRUG
-
Carboplatin-based chemotherapy
As prescribed
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2012-09-30
- Completion
- 2012-09-30
Countries
- Australia
- Belgium
- Canada
- Czechia
- Denmark
- France
- Germany
- Hong Kong
- Hungary
- Italy
- Netherlands
- Poland
- Russia
- Spain
- Taiwan
- United Kingdom
Study Locations
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