A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Bevacizumab
Intervention description: 500 milligram per square meter (mg/m²) given intravenously on Day 1 of each 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity.; 75 mg/m² given intravenously on Day 1 of 21-day cycle for a maximum of 4 cycles; 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 of 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity
Intervention MeSH terms: Bevacizumab; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line
      treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a
      maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease
      progression or unacceptable toxicity occurs. The primary objective of this study is to
      measure how long this treatment could prevent the disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV NSCLC that
             is not amenable to curative therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  At least 1 unidimensionally measurable lesion meeting the Response Evaluation Criteria
             In Solid Tumors (RECIST) criteria

          -  Adequate organ function, including the following:

               -  Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
                  (ANC) ≥1.5 x 10^9 per Liter (10^9/L), platelets ≥100 x 10^9/L, and hemoglobin ≥10
                  gram per deciliter (g/dL)

               -  Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN); alkaline
                  phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase
                  (ALT) ≤3.0 x ULN (AP, AST, and ALT ≤5 x ULN is acceptable if liver has tumor
                  involvement)

               -  Renal: calculated creatinine clearance (CrCl) ≥45 milliliter per minute (mL/min)
                  based on the original weight-based Cockcroft and Gault formula, and serum
                  creatinine ≤1.5 x ULN

               -  At the time of enrollment, if the urinalysis dipstick result is ≥2+ for protein,
                  a 24-hour urine collection should be taken. In these cases, participants must
                  have ≤1g protein/24 hours to be eligible for study participation

          -  Participants must sign an Informed Consent Document (ICD)

        Exclusion Criteria:

          -  Have received prior systemic anticancer therapy for lung cancer (including adjuvant
             early-stage treatment for NSCLC)

          -  Have a serious cardiac condition, such as myocardial infarction within 6 months,
             angina, or heart disease, as defined by the New York Heart Association Class III or IV

          -  Have a second primary malignancy that is clinically detectable at the time of
             consideration for study enrollment

          -  Have known central nervous system (CNS) disease, other than stable, treated brain
             metastasis. Stable, treated brain metastasis is defined as metastasis having no
             evidence of progression or hemorrhage after treatment and no ongoing requirement for
             dexamethasone, as ascertained by clinical examination and post-treatment brain imaging
             (Computed Tomography [CT] scan or magnetic resonance imaging [MRI])

          -  Are receiving concurrent administration of any other antitumor therapy

          -  Have a history of gastrointestinal fistula, perforation, or abscess, inflammatory
             bowel disease, or diverticulitis

          -  Have had significant weight loss (that is, ≥10%) over the previous 6 weeks before
             study entry

          -  Have a history of gross hemoptysis (bright red blood of ≥½ teaspoon per episode of
             coughing) <3 months prior to enrollment or history or evidence of inherited bleeding
             diathesis or coagulopathy with the risk of bleeding

          -  Are taking or have recently taken (within 10 days of enrollment) full-dose oral or
             parenteral anticoagulants or thrombolytic agents for therapeutic purposes.
             Prophylactic use of anticoagulants is allowed; international normalized ratio (INR)
             should be <1.5 at study enrollment

          -  Have a history of hypertension, unless hypertension is well controlled upon study
             entry (≤150/90 millimeter of mercury [mm Hg]) and the participant is on a stable
             regimen of antihypertensive therapy. Participants should not have any prior history of
             hypertensive crisis or hypertensive encephalopathy

          -  Have had major surgery, open biopsy, or significant traumatic injury within 28 days
             prior to study enrollment, or anticipate the need for major surgical procedure during
             the course of the study

          -  History of thrombotic disorders within the last 6 months prior to entry