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A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT00556322 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2015-02-23

Study results available
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Summary

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

Conditions

Interventions

DRUG

Alimta or Taxotere

500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)

DRUG

erlotinib [Tarceva]

150mg po daily

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Malaysia
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom
  • Venezuela

Study Locations

More Related Trials

Entities

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 NCT00556322 on ClinicalTrials.gov