NCT00497770

An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed

Non-small Cell Lung Cancer: The Impact of Ethnic Origin on Patients Being Treated Second Line With Pemetrexed - An Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 434 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This large, non-randomized observational study is being conducted to provide data about the impact of ethnic origin on outcomes and resource utilization during the 2nd line treatment of non-small cell lung cancer (NSCLC) in a routine medical care setting.

Detailed description

This is a large 1000 patient single arm observational study being conducted to determine the impact of ethnic origin (Caucasian, African-Americans, Asian-Americans, and Hispanics) on patients being treated for 2nd line advanced NSCLC with pemetrexed given in routine clinical practice. Data will be collected on disease control rate by pemetrexed as defined by Response Rate (RR) (Complete Response (CR) + Partial Response (PR)), Stable Disease (SD) and toxicities. In addition, overall survival, progression-free survival, treatment toxicities, activities of daily living, symptom burden and resource utilization will also be observed. To meet the study goals, a total of 400 Caucasians, 200 African- Americans, 200 Asian-Americans, and 200 Hispanics will be accrued to this study.

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	Pemetrexed	Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient

Timeline

• Start date: 2007-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2007-07-09
• Last updated: 2012-05-02
• Results posted: 2012-04-11

Locations

38 sites across 2 countries: United States, Puerto Rico