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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Neulasta® (pegfilgrastim)
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, NSCLC, Fever, Neutropenia, Neulasta®, Quality of Life, Chemotherapy, Amgen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Quality of Life

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 21, 2005
    Last Updated
    April 2, 2009
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00115206
    Brief Title
    Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer
    Keywords
    Non Small Cell Lung Cancer, NSCLC, Fever, Neutropenia, Neulasta®, Quality of Life, Chemotherapy, Amgen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Neulasta® (pegfilgrastim)
    Primary Outcome Measure Information:
    Title
    Quality of Life
    Secondary Outcome Measure Information:
    Title
    Quality of Life, *Neutropenia, *Hospitalization, *Disease Response

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_11_GCSFSD01_20020121.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.neulasta.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

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

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