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

Lilly

Status: Completed

Conditions: Lung Neoplasms

Treatments: Drug: Pemetrexed

Study type: Observational

Funder types: Industry

Identifiers

NCT00497770

10733

H3E-US-B001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 434 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-small cell lung cancer (NSCLC) (any histologic type)
• Stage IIIB or IV disease
• Should have had 1 line of chemotherapy for Metastatic disease
• Adequate hematologic, hepatic and renal function
• Measurable or evaluable disease

Exclusion criteria

• Pregnant or lactating females

Trial design

434 participants in 4 patient groups

Caucasian

Description:

Caucasian patients receiving Alimta for 2nd line NSCLC

Treatment:

Drug: Pemetrexed

African American

Description:

African American patients receiving Alimta for 2nd line NSCLC

Treatment:

Drug: Pemetrexed

Asian American

Description:

Asian American patients receiving Alimta for 2nd line NSCLC

Treatment:

Drug: Pemetrexed

Hispanic

Description:

Hispanic patients receiving Alimta for 2nd line NSCLC

Treatment:

Drug: Pemetrexed