Overview
Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy
Status:
Completed
Completed
Trial end date:
2004-07-01
2004-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to estimate the relationship between patient reported outcomes (PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with or without Neulasta® (pegfilgrastim).Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Amgen
Criteria
Inclusion Criteria: - Non-small cell lung cancer, not previously treated with chemotherapyor radiotherapy - ECOG performance status 0 or 1 - ANC greater than or equal to 2.0 x
10^9/L Exclusion Criteria: - Cancer other than NSCLC within 5 years of enrollment, with the
exception of surgically cured basal cell carcinoma or in situ carcinoma of the cervix -
Treatment less than or equal to 30 days prior with any experimental agent - Subjects with
symptomatic brain metastases - Subject is currently enrolled or has not yet completed at
least 30 days since ending other investigational device or drug trial(s) or is receiving
other investigational agent(s)