Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
Dec 2012
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4021017
NCT ID:
NCT00907504
Start Date:
July 2010
Completion Date:
May 2014
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms