A Study of Avastin (Bevacizumab) in Combination With Standard of Care Treatment in Patients With Lung Cancer

• Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
• Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
• Disease control rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
• Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
• Safety (incidence of adverse events) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

This open-label, randomized, multicenter study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with standard of care treatment in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Patients will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with Avastin plus a platinum doublet-containing therapy and a minimum of two cycles of Avastin maintenance treatment prior to PD. Patients will be randomly assigned to one of two treatment arms to receive either Avastin plus standard of care treatment or standard of care treatment alone.

• Drug: bevacizumab [Avastin]
  7.5 or 15 mg/kg intravenously on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
• Drug: Standard of care treatment
  Investigator's choice of standard of care treatment on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent

• Experimental: A
  Interventions:

  • Drug: bevacizumab [Avastin]
  • Drug: Standard of care treatment
• Active Comparator: B
  Intervention: Drug: Standard of care treatment

Inclusion Criteria:

• Adult patients, age >/=18 years
• Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
• Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment 4-6 cycles of Avastin plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Avastin (monotherapy) maintenance treatment prior to first progression of disease
• No treatment interruption of Avastin treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
• Randomization within 4 weeks of progression of disease
• At least one unidimensionally measurable lesion meeting RECIST criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

• Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
• History of hemoptysis >/=grade 2 within 3 months of randomization
• Major cardiac disease