CPG 7909 Injection in Non-Small Cell Lung Cancer

• Drug: CPG 7909
  
  CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle.
  Other Name: ProMune, PF-3512676
• Drug: Chemotherapy
  

  A taxane and a platinum compound given on week one of three-week cycles:

  Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6

• Drug: Chemotherapy
  

  A taxane and a platinum compound given on week one of three-week cycles:

  Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6

  Other Name: Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN)

• Experimental: 1
  
  Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
  Interventions:
  

  • Drug: CPG 7909
  • Drug: Chemotherapy
• Active Comparator: 2
  
  Chemotherapy (a taxane and a platinum compound)
  Intervention: Drug: Chemotherapy

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC).
• Patients must have measurable disease according to the RECIST criteria.

Exclusion Criteria:

• Prior treatment with chemotherapy; patients may have received prior radiotherapy.
• Patients with suspected or known CNS metastases.