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AVAiL (BO17704): phase III trial – efficacy of Avastin maintained

AVAiL: phase III, randomised, placebo-controlled trial of first-line Avastin plus cisplatin/gemcitabine in patients with previously untreated, non-squamous NSCLC

 
AVAiL: trial design

AVAiL: trial design8

Reprinted with permission. ©2009 American Society of Clinical Oncology. All rights reserved.

  • Phase III, multicentre, randomised placebo-controlled trial of first-line Avastin in patients with previously untreated, advanced or recurrent non-squamous NSCLC.8
  • All patients received six cycles of chemotherapy: cisplatin (80mg/m2) on day 1 and gemcitabine (1,250mg/m2) on days 1 and 8.
  • Patients were randomised to receive one of the following (from day 1)
    • Avastin 7.5mg/kg every 3 weeks plus chemotherapy until PD (n=345)
    • Avastin 15mg/kg every 3 weeks plus chemotherapy until PD (n=351)
    • placebo plus chemotherapy every 3 weeks until PD (n=347).
  • The trial was not designed to compare the two Avastin doses directly, but to compare each of the Avastin doses with placebo.
 
  • Primary endpoint
    • PFS (Note: the two Avastin-containing arms were compared with the chemotherapy only arm and not with each other).
  • Secondary endpoints
    • ORR
    • duration of response
    • OS
    • safety.
 

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