Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer

• Drug: axitinib
  5mg BID po up to max 10mg BID po
  Other Name: AG-013736
• Drug: axitinib
  5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy
  Other Name: AG-013736
• Drug: chemotherapy
  Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
  Other Name: alimta
• Drug: axitinib
  5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy

• Experimental: I
  Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
  Intervention: Drug: axitinib
• Experimental: II
  Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
  Intervention: Drug: axitinib
• Active Comparator: III
  pemetrexed and cisplatin
  Intervention: Drug: chemotherapy
• Experimental: IV
  Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
  Intervention: Drug: axitinib
• Active Comparator: V
  pemetrexed and cisplatin
  Intervention: Drug: chemotherapy

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
• Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
• Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
• Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
• Candidate for primary treatment with cisplatin and pemetrexed

Exclusion Criteria:

• Any histological/cytological evidence of predominantly squamous NSCLC.
• Small cell or carcinoid lung cancer patients are also ineligible.
• NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
• Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
• Prior treatment with a VEGF or VEGFR inhibitor.