Conditions: Non-Squamous Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 86
Healthy volunteers: no

Brief summary:
This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: cisplatin intervention 3: gemcitabine intervention 4: gemcitabine
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle intervention 2: 60mg/m2 on day 1 of each 3 week cycle intervention 3: 1200mg/m2 on days 1-8 of each 3 week cycle intervention 4: 1000mg/m2 on days 1-8 of each 3 week cycle

Protocol document: