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

• Overall objective response rate (ORR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• Progression Free Survival (PFS) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
• Overall safety profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Patient reported outcomes (PROs) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Pharmacokinetics of CP- 751,871 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Anti drug antibody occurrence [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Change in serum IGF1 levels [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

• Overall objective response rate (ORR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• Progression Free Survival (PFS) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
• Overall safety profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Patient reported outcomes (PROs) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Pharmacokinetics of CP 751,871 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Anti drug antibody occurrence [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Change in serum IGF1 levels [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.

• 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.