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

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 21, 2005
Last updated: April 2, 2009
Last verified: April 2009
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).

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Neulasta® (pegfilgrastim) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Quality of Life

Secondary Outcome Measures:
  • Quality of Life, *Neutropenia, *Hospitalization, *Disease Response

Study Start Date: July 2002
Estimated Study Completion Date: July 2004

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00115206

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00115206     History of Changes
Other Study ID Numbers: 20020121
Study First Received: June 21, 2005
Last Updated: April 2, 2009

Keywords provided by Amgen:
Non Small Cell Lung Cancer
Quality of Life

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on August 17, 2017