Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy

A Pilot Study of the Effects of Neutropenia on Patient Reported Outcomes During Chemotherapy With or Without Neulasta® (Pegfilgrastim) in Subjects With Advanced NSCLC

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00115206

Enrollment

Unknown

Registered

2005-06-22

Start date

2002-07-31

Completion date

2004-07-31

Last updated

2009-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, NSCLC, Fever, Neutropenia, Neulasta®, Quality of Life, Chemotherapy, Amgen

Brief 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).

Interventions

DRUGNeulasta® (pegfilgrastim)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Non-small cell lung cancer, not previously treated with chemotherapy or 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)

Design outcomes

Primary

Measure	Time frame
Quality of Life	—

Secondary

Measure	Time frame
Quality of Life, Neutropenia, Hospitalization, *Disease Response	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026