CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,140 enrolled
Drug / intervention
ZD6474 (vandetanib) +1 moredrug
Likely dose
ZD6474 (vandetanib) once daily oral tabletAI-extracted
Key inclusion· 2
  • Histologically or cytologically confirmed locally advanced or metastatic (Stage IIIB-IV) NSCLC
  • Prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
Key exclusion· 3
  • Prior chemotherapy, surgery, or systemic anti-cancer therapy within 4 weeks before study start
  • Three or more prior chemotherapy regimens
  • Significant cardiovascular events

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00404924
NCT00404924Phase 3Completed

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)

Genzyme, a Sanofi Company·interventional·Posted Nov 29, 2006·Updated Sep 30, 2016

In Brief

A Phase 3 clinical trial evaluating ZD6474 (vandetanib) and Best Supportive Care for Non-Small-Cell Lung Carcinoma. Completed, enrolled 1,140 participants across 102 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Mexico, Netherlands, Peru, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 29, 2006
Enrollment StartNov 1, 2006
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.6 years ago

Interventions

ZD6474 (vandetanib)drug

once daily oral tablet

Best Supportive Careother

standard of care