A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab; Docetaxel; Erlotinib; Pemetrexed
Intervention description: Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.; Docetaxel 60 or 75 milligram per meter square (mg/m^2) on Day 1 every 21 days.; Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.; Pemetrexed 500 mg/m^2 IV over 10 minutes on Day 1 every 21 days.
Intervention MeSH terms: Bevacizumab; Docetaxel; Pemetrexed; Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed non-squamous NSCLC

          -  Documented progression of disease (locally recurrent or metastatic) per investigator
             assessment following first-line treatment with 4-6 cycles of Bevacizumab plus a
             platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of
             Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease

          -  No treatment interruption of Bevacizumab 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 v1.1 criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Participants with adequate hematological, liver, and renal function

          -  Female participants must not be pregnant or breast-feeding. Female participants of
             childbearing potential and fertile male participants must agree to use a highly
             effective contraceptive during the trial and for a period of at least 6 months
             following the last administration of trial drug(s)

        Exclusion Criteria:

          -  Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a
             predominant squamous component

          -  Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local
             laboratory testing

          -  History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of
             randomization

          -  History or evidence of inherited bleeding diathesis or coagulopathy with a risk of
             bleeding and active gastrointestinal bleeding

          -  Major cardiac disease

          -  Treatment with any other investigational agent within 28 days prior to randomization

          -  Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs
             foreseen

          -  Malignancy other than NSCLC within 5 years prior to randomization and evidence of any
             other disease that contraindicates the use of an investigational or SOC drug