Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy

An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patient With Non-Small Cell Lung Cancer Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120679

Enrollment

Unknown

Registered

2005-07-19

Start date

2002-10-31

Completion date

2003-12-31

Last updated

2007-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer, darbepoetin alfa, Amgen

Brief summary

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in non small cell lung cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Interventions

DRUGdarbepoetin alfa

DRUGrecombinant human erythropoietin (rHuEPO)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Subjects receiving multi-cycle chemotherapy for non-small cell lung cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function

Exclusion criteria

- Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection

Design outcomes

Primary

Measure	Time frame
Anemia correction	—

Secondary

Measure	Time frame
Patient preference	—
Activities of daily living	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026