Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.

Inclusion Criteria:

• Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
• Male or female > 18 years
• Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
• Adequate organ function

Exclusion Criteria:

• Uncontrolled hypertension or diabetes;
• Pregnant female;
• Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.