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A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy


Inclusion Criteria:



- Confirmed locally advanced or metastatic NSCLC

- Failure of at least one but not more than two prior chemotherapy regimens

Exclusion Criteria:

- Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent),
sorafenib (Nexavar)

- Chemotherapy or other type of anti cancer therapy within 4 weeks of study start

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.

Outcome Time Frame:

progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.

Safety Issue:

No

Principal Investigator

ZD6474 Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00057

NCT ID:

NCT00364351

Start Date:

August 2006

Completion Date:

December 2012

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteBloomington, Indiana  
Research SiteHays, Kansas  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington