Conditions: Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 303
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: bevacizumab [Avastin] intervention 3: Carboplatin-based chemotherapy
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle intervention 2: 15mg/kg iv on day 1 of each 3 week cycle intervention 3: As prescribed

Protocol document: