A Randomized, Double-blinded, Placebo-controlled, Multicenter Phase III Study Comparing Bevacizumab Plus Carboplatin/Paclitaxel Versus Placebo Plus Carboplatin / Paclitaxel in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Locally advanced (Stage IIIb not amenable for combined modality treatment),
metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate haematological, renal and liver function
Exclusion Criteria:
- Prior chemotherapy or treatment with another systemic anti-cancer agent for the
current stage of the disease (IIIb, IV or recurrent)
- Mixed non-small cell and small cell tumours or mixed adenosquamous carcinomas with a
predominant squamous component
- Evidence of tumour invading major blood vessels on imaging
- CNS metastases, even if previously treated
- History of haemoptysis in the 3 months prior to enrollment
- History or evidence of inherited bleeding diathesis or coagulopathy
- Uncontrolled hypertension and/or history of hypertensive crisis or hypertensive
encephalopathy
- Clinically significant cardiovascular or vascular disease
- Malignancies other than NSCLC within 5 years prior to randomization, except for
adequately treated carcinoma in situ of the cervix, basal or squamous cell skin
cancer, or localized prostate cancer or ductal carcinoma in situ treated surgically
with curative intent