Study of Participants With Advanced Non-Small Cell Lung Cancer
Condition: Advanced Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Carboplatin; Paclitaxel; Bevacizumab
Intervention description: Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.; Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes.; Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours; Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression 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: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology; Advanced Lung Cancer; Non-Small Cell Lung Cancer; Lung Cancer

Summary:

      The purpose of this study is to compare the regimens of pemetrexed, carboplatin with
      pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance
      in participants with Stage IV nonsquamous non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  a histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC)
             [Stage IV from the American Joint Committee on Cancer Staging Criteria (AJCC) staging
             system, version 7.0, including both M1a and M1b], other than predominantly squamous
             cell histology, that is not amenable to curative therapy. Participants may not have
             received any prior systemic chemotherapy, immunotherapy, targeted therapy, or
             biological therapy, including adjuvant therapy, for any stage of NSCLC.

          -  prior radiation therapy is allowed to < 25% of the bone marrow; however, prior
             radiation to the whole pelvis not allowed.

          -  good performance status.

          -  adequate organ function.

          -  estimated life expectancy of at least 12 weeks.

        Exclusion Criteria:

          -  known central nervous system (CNS) disease, other than treated brain metastasis.

          -  major surgical procedure, open biopsy, open pleurodesis, or significant traumatic
             injury within 28 days prior to study or have an anticipated need for major surgery
             during the study.

          -  core biopsy or other minor surgical procedure, excluding placement of vascular access
             device, closed pleurodesis, thoracentesis, and mediastinoscopy, within 7 days prior to
             study.

          -  history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel
             disease, or diverticulitis.

          -  currently receiving ongoing treatment with full-dose warfarin or equivalent

          -  significant vascular disease within 6 months prior to Day 1 of Cycle 1.

          -  evidence of bleeding diathesis or coagulopathy.

          -  serious concomitant systemic disorder that, in the opinion of the investigator, would
             compromise the participant's ability to adhere to the protocol.

          -  serious cardiac condition, such as myocardial infarction, angina, or heart disease.

          -  inadequately controlled hypertension.

          -  any prior history of hypertensive crisis or hypertensive encephalopathy.

          -  serious, nonhealing wound, active ulcer, or untreated bone fracture.

          -  another active malignancy, other than superficial basal cell and superficial squamous
             (skin) cell, or carcinoma in situ of the cervix within the last 5 years.

          -  previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab
             (prior intravitreal administration of bevacizumab does not preclude study
             participation).

          -  pregnant or breast-feeding.

          -  history of stroke or transient ischemic attack within 6 months prior to study.

          -  known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or
             bevacizumab.

          -  history of hemoptysis within 3 months prior to randomization.

          -  unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

          -  unwilling to take folic acid or vitamin B12 supplementation.

          -  clinically significant third-space fluid collections, for example, ascites or pleural
             effusions that cannot be controlled by drainage. Participants with M1a disease with
             pleural effusions are eligible if the effusions can be adequately controlled.