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Study Complete
Sponsor ID
20020121

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

Sponsor ID
20020121
Clinicaltrials.gov ID
NCT00115206
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 4
Product
pegfilgrastim
Type
Interventional
Masking
None (Open Label)
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Jul 2002 - N/A
    Inclusion and Exclusion 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)