Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

• Drug: Cisplatin
  Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
  Other Name: Platinol-AQ
• Drug: Gemcitabine
  Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
  Other Name: Gemzar
• Drug: PF-3512676
  PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
• Drug: Gemcitabine + Cisplatin
  Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
  Other Name: Gemzar

• Experimental: A
  Standard of Care chemotherapy plus experimental intervention (PF-3512676)
  Interventions:

  • Drug: Cisplatin
  • Drug: Gemcitabine
  • Drug: PF-3512676
• Active Comparator: B
  Standard of Care chemotherapy
  Interventions:

  • Drug: Cisplatin
  • Drug: Gemcitabine + Cisplatin

Inclusion Criteria:

• Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
• No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

• Small cell or carcinoid lung cancer
• Known Central Nervous System (CNS) metastasis
• Pre-existing auto-immune or antibody mediated diseases