Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments vandetanib, erlotinib
Phase phase 3
Targets EGFR, VEGF
Sponsor AstraZeneca
Start date August 2006
End date September 2008
Trial size 1574 participants
Trial identifier NCT00364351, D4200C00057, EUDRACT No. 2006-000259-16

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Erlotinib
erlotinib Tarceva®
oral dose
(Experimental)
Vandetanib
vandetanib ZD6474
once daily oral tablet

Primary Outcomes

Measure
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 Outcomes

Measure
Overall Survival (OS)
time frame: Time to death in months
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
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
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
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 - 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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.