Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Information provided by:
Amgen Identifier:
First received: October 27, 2004
Last updated: February 12, 2009
Last verified: February 2009
The purpose of this research study is to evaluate the safety and effectiveness of Neulasta® (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). This study is considered to be "investigational" because previous studies with Neulasta® used next day dosing and not same day dosing.

Condition Intervention
Lung Cancer
Non-Small Cell Lung Cancer
Other: PI Discretion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pegfilgrastim Given Same Day as or Day After Carboplatin and Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • incidence of infection [ Time Frame: during treatment ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: July 2003
Study Completion Date: February 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pegfilgrastim Other: PI Discretion
PI Discretion
PLACEBO Other: PI Discretion
PI Discretion


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced or Metastatic NSCLC
Eligibility Criteria: - Age 18 years or older - Diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) - Have not received any prior chemotherapy - Have not received radiation therapy or undergone major surgery within the past 2 weeks
  Contacts and Locations
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Please refer to this study by its identifier: NCT00094822

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00094822     History of Changes
Other Study ID Numbers: 20030123 
Study First Received: October 27, 2004
Last Updated: February 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Metastatic Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on May 26, 2016