A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Pemetrexed; Paclitaxel; Carboplatin; Bevacizumab; Bevacizumab
Intervention description: Induction therapy 500 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days; Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation; Induction therapy 200 mg/m^2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days; Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days; Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days; Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 939.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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.