Conditions: Non-Squamous Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 376
Healthy volunteers: no

Brief summary:
This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is \<500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: cisplatin intervention 3: pemetrexed
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 of each 3-week cycle intervention 2: 75mg/m2 iv on day 1 of each 3-week cycle intervention 3: 500mg/m2 iv on day 1 of each 3-week cycle

Protocol document: