Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

• Carcinoma, Squamous Cell
• Carcinoma, Adenosquamous
• Carcinoma, Large Cell
• Carcinoma, Non-Small-Cell Lung

• Drug: CP-751,871 (Figitumumab)
  CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
• Drug: Carboplatin
  Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
• Drug: Paclitaxel
  Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
• Drug: Carboplatin
  Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
• Drug: Paclitaxel
  Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.

• Experimental: A
  Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
  Interventions:

  • Drug: CP-751,871 (Figitumumab)
  • Drug: Carboplatin
  • Drug: Paclitaxel
• Active Comparator: B
  Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
  Interventions:

  • Drug: Carboplatin
  • Drug: Paclitaxel

Inclusion Criteria:

• Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
• Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
• No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
• Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
• ECOG performance status (PS) 0 or 1.

Exclusion Criteria:

• Patients with symptomatic central nervous system (CNS) metastases are not permitted.
• Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
• Patients with other active cancer types are not permitted.