Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy

To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib.

Official Title

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.

Conditions

• Non Small Cell Lung Cancer

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Further Details

• Primary Outcomes: Demonstrate an improvement in Progression Free Survival for ZD6474 compared with erlotinib in patients with locally advanced or metastatic NSCLC after failure of at least one but no more than two, prior chemotherapy regimes.
• Secondary Outcomes: To demonstrate an overall improvement in survival for ZD6474 compared with erlotinib

Study Start

August 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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
  

  Total Enrolment

  1150 (expected)

  Contact Details

  AstraZeneca Cancer Support Network 1-866-992-9276 information.center@astrazeneca.com

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