Overview

This trial is active, not recruiting.

Condition non-small-cell lung carcinoma
Treatments zd6474 (vandetanib), best supportive care
Phase phase 3
Sponsor AstraZeneca
Start date November 2006
End date October 2009
Trial size 1168 participants
Trial identifier NCT00404924, D4200C00044, EUDRACT Number 2006-002384-12

Summary

This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.

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
(Placebo Comparator)
Best Supportive Care
best supportive care
standard of care
(Experimental)
Vandetanib + Best Supportive Care
zd6474 (vandetanib) ZACTIMA™
once daily oral tablet
best supportive care
standard of care

Primary Outcomes

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

Secondary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Objective Response Rate (ORR)
time frame: Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression.
Disease Control Rate (DCR)
time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Duration of Response (DoR)
time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF)
time frame: Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and 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: - Patients with Non-small cell lung cancer for which the standard cancer treatments of surgery, chemotherapy, radiation or other anticancer drugs are no longer appropriate treatments for you. Exclusion Criteria: - Patients who have had standard cancer treatments of surgery, chemotherapy or other systemic anti-cancer therapy within 4 weeks before start of study therapy. - Three or more prior chemotherapy regimens. - Significant cardiovascular events.

Additional Information

Official title A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by AstraZeneca.