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Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy

NCT00858364 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2549

Last updated 2022-11-30

Study results available
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Summary

This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.

Conditions

Interventions

DRUG

Darbepoetin alfa

Administered subcutaneously once every 3 weeks

DRUG

Placebo

Administered subcutaneously once every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-17
Primary Completion
2017-06-07
Completion
2017-06-07

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Croatia
  • Czechia
  • Germany
  • Greece
  • Hong Kong
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Luxembourg
  • Malaysia
  • Mexico
  • Netherlands
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Serbia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00858364 on ClinicalTrials.gov