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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00364351
• Date of registration: 14/08/2006
• Primary sponsor: AstraZeneca
• Public title: Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
• Scientific 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
• Date of first enrolment: August 2006
• Target sample size: 1240
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00364351
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Philippines, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: ZD6474 Medical Science Director, MD
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non Small Cell Lung Cancer

Intervention(s)

Drug: Erlotinib

Drug: Vandetanib

Primary Outcome(s)

Progression-Free Survival (PFS) [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.]

Secondary Outcome(s)

Disease Control Rate (DCR) [Time Frame: RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression]

Objective Response Rate (ORR) [Time Frame: RECIST tumour assessments 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 up to 21 months]

Overall Survival (OS) [Time Frame: Time to death in months]

Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough [Time Frame: Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit]

Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea [Time Frame: Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit]

Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain [Time Frame: Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit]

Secondary ID(s)

D4200C00057

EUDRACT No. 2006-000259-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors