A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer

Randomized, Open-Label, Phase 3 Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab Versus Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer

This study will compare overall survival in participants with Stage IIIB or IV nonsquamous non-small cell lung cancer.

Inclusion Criteria:

• You must sign an informed consent document for clinical research.
• You must have Stage IIIB or Stage IV nonsquamous non-small cell lung cancer.
• You must not have received any prior treatment for your disease.
• Prior radiation therapy is allowed to < 25% of the bone marrow; however, prior radiation to the whole pelvis is not allowed. If you have had radiation therapy to the chest, you are not eligible to participate.
• You must be at least 18 years of age or older.
• You must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) or disease can be evaluated on computed tomography (CT) scan.
• Your test results assessing the function of blood forming tissue, kidneys and liver must be satisfactory.
• Women must be sterile, postmenopausal or on contraception and men must be sterile (for example post-vasectomy) or on contraception.

Exclusion Criteria:

• You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
• You cannot have Non-small Cell Lung Carcinoma (NSCLC) of predominantly squamous cell histology.
• You cannot have known central nervous system (CNS) disease, other than stable, treated brain metastasis.
• You cannot have undergone a surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days of starting the study treatment, or have an anticipated need for major surgery during the study.
• You cannot have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
• You are currently receiving ongoing treatment with full-dose warfarin or equivalent.
• You cannot have significant vascular disease, serious cardiac conditions (such as heart attack), stroke or transient ischemic attack within 6 months of the trial.
• You cannot have evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
• You cannot have inadequately controlled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.
• You cannot have a serious, nonhealing wound, active ulcer, or untreated bone fracture.
• You cannot have another form of cancer, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.
• You cannot have received an investigational treatment within 30 days prior to the trial.
• You cannot have previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab.
• You cannot be pregnant or breast-feeding.
• You cannot have a known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.
• You cannot have a history of hemoptysis (coughing blood) within 3 months prior to the trial.
• You are unable to stop taking aspirin more than 1.3 grams per day or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• You are unable or unwilling to take folic acid or vitamin B12 supplementation.
• You are unable to take corticosteroids.
• You have any other on-going illnesses including active infections that may not allow you to adhere to the requirements of the trial.