BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Step 1 Inclusion Criteria:

   - Histologically confirmed newly diagnosed nonsquamous non-small cell lung cancer
   (NSCLC), including the following subtypes:

      - Adenocarcinoma

      - Large cell undifferentiated

      - Bronchoalveolar cell

      - non-small cell carcinoma, not otherwise specified

   - Unresectable stage IIIA or stage IIIB disease

      - Patients with stage IIIA disease with mediastinal lymph node enlargement between
      1 cm and 2.0 cm on computerized tomography (CT) scan must have these nodes
      biopsied (pathologic confirmation) to rule out resectability

      - Metastases to contralateral mediastinal or supraclavicular nodes allowed

   - Measurable or non-measurable disease, as defined by Response Evaluation Criteria in
   Solid Tumours (RECIST) criteria

   - Eastern Cooperative Oncology Group (ECOG) performance status 0-1

   - White blood cell (WBC) ≥ 4,000/mm³ OR Absolute neutrophil count (ANC) ≥ 2,000/mm³

   - Platelet count ≥ 140,000/mm³

   - Hemoglobin ≥ 9.0 g/dL

   - Total bilirubin ≤ 1.5 mg/dL

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)+ ≤ 2.5 times upper
   limit of normal

   - Serum creatinine ≤ 1.5 mg/mL OR creatinine clearance ≥ 45 mL/min

   - Urine protein:creatinine ratio < 1.0 by urine dipstick OR < 1 g of protein by 24-hour
   urine collection

   - INR ≤ 1.5 OR ≤ 3.0 if patient is on therapeutic anticoagulation

   - PTT normal

   - Fertile patients must use effective contraception before, during, and for ≥ 6 months
   after completion of bevacizumab

Step 1 Exclusion Criteria:

   - Significant pleural effusion

   - CNS metastases by head CT scan or MRI within the past 4 weeks

   - Pregnant or breast-feeding

   - Prior chemotherapy or monoclonal antibodies for other cancers within 5 years prior to
   registration

   - Prior chemotherapy for lung cancer

   - Prior chest radiotherapy

   - Ongoing (lasting > 14 days) or active infection or ongoing (lasting > 14 days) fever
   within the past 6 months

   - Gross hemoptysis ≥ grade 2 (defined as ≥ ½ teaspoon of bright red blood per episode)
   within the past 3 months

   - Bleeding ≥ grade 2 or any bleeding requiring intervention

   - Clinically significant cardiovascular disease

   - Myocardial infarction within the past 6 months

   - New York Heart Association class III-IV congestive heart failure

   - Unstable angina pectoris

   - Serious cardiac arrhythmia requiring medication within the past 4 weeks

   - History of hypertensive crisis or hypertensive encephalopathy

   - Stroke or transient ischemic attack within the past 6 months

   - Peripheral vascular disease ≥ grade 2 within the past 6 months

   - Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the
   past 6 months

   - Psychiatric illness or social situation that would limit compliance with study
   requirements

   - History of uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg) while on
   stable regimen of antihypertensive therapy

   - Significant traumatic injury or serious non-healing wound, ulcer, or bone fracture
   within the past 4 weeks

   - Concurrent major surgical procedure

   - Having anticipated major surgical procedure(s) during the course of the study

   - Concurrent daily aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents
   (NSAIDs) known to inhibit platelet function

   - Recognized immunodeficiency disease, including cellular immunodeficiencies,
   hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital
   immunodeficiencies

   - Pre-existing medical condition requiring chronic steroids or immunosuppressive therapy

   - Autoimmune disease

   - Known hepatitis B or C

   - Immunotherapy (e.g., interferon, interleukin, sargramostim [GM-CSF], or filgrastim
   [G-CSF]) within 28 days prior to registration

   - Prior splenectomy

   - Hypersensitivity to any component of bevacizumab

   - Prior core biopsy or any other minor surgical procedure, excluding the placement of a
   vascular access device, within 7 days prior to registration

Step 2 Inclusion Criteria:

   - Serum creatinine ≤ 1.5 mg/ml or calculated creatinine clearance ≥ 45 ml/min

   - Urine dipstick must be ≤ 0-1+. If urine dipstick results > 1+, 24 hour urine for
   protein must be obtained. Patients must have < 1g protein/24 hours to participate in
   the study

   - Patient must be registered to step 2 within 28 days of completion of consolidation
   chemotherapy

   - Patient must have met all eligibility requirements for Step 1

   - Platelets ≥ 100,000/mm3

Step 2 Exclusion Criteria:

   - Progressive disease or unevaluable disease per RECIST criteria upon post-
   consolidation chemotherapy evaluation

   - Autoimmune disease