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

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).

Completed

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Key information

Conditions

Non-small Cell Lung Cancer Agranulocytosis Body Temperature Changes Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cytopenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neutropenia Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neulasta® (pegfilgrastim)

Drug

Primary outcomes

Quality of Life

Secondary outcomes

Quality of Life, *Neutropenia, *Hospitalization, *Disease Response

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Study completion: 2004
First posted: Jun 22, 2005
Registry last updated: Apr 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed