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Lung (Non-Small Cell)

A Phase III, Randomized, Double-Blind, Multi-Center Parallel-Group Study to Assess the Efficacy of Vandetanib (ZACTIMA, ZD6474) versus Erlotinib (TARCEVA) in Patients With Locally Advanced or Metastatic (Stage IIIB - IV) Non-Small Cell Lung Cancer (NSCLC) after Failure of at least One Prior Cytotoxic Chemotherapy

Unique Data Set IDLungNo_AstraZe_2006_164
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients1574Comparator (Control) Arm Enrolled Patients617RandomizationYesClinicalTrial.gov IDNCT00364351ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00364351?term=D4200C00057&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeSDTM

Clinical Trial Title

A Phase III, Randomized, Double-Blind, Multi-Center Parallel-Group Study to Assess the Efficacy of Vandetanib (ZACTIMA, ZD6474) versus Erlotinib (TARCEVA) in Patients With Locally Advanced or Metastatic (Stage IIIB - IV) Non-Small Cell Lung Cancer (NSCLC) after Failure of at least One Prior Cytotoxic Chemotherapy

Trial Summary and Conditions

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

Data Summary

Control arm data files include SDTM/RDB data on : Demography (subject disposition, protocol deviation, baseline characteristic) safety (Adverse events/exposure/labs/vital signs), Efficacy (Overall survival/PFS/Biomarker/Quality of Life/PK).

Study Objectives

Primary objectives The primary objective of this study was to demonstrate an improvement in PFS for vandetanib compared with erlotinib (TARCEVA?) in patients with locally advanced or metastatic NSCLC after failure of at least 1 but no more than 2 prior cytotoxic chemotherapy regimens. Eligible patients had documented history of progressive disease or unacceptable toxicity either during or after treatment with prior cytotoxic chemotherapy treatment for the disease. Secondary objectives The secondary objectives of the study were: 1. To demonstrate an improvement in OS for vandetanib compared with erlotinib. 2. To demonstrate an improvement in the objective response rate (ORR), disease control rate (DCR), and duration of response (DOR) for vandetanib compared with erlotinib. 3. To demonstrate an improvement in the time to deterioration of pain, dyspnea, cough in patients treated with vandetanib compared with erlotinib, based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) plus Lung Cancer Module (QLQ-LC13). 4. To study the safety and tolerability of vandetanib compared with erlotinib. 5. To investigate the population pharmacokinetics (PK) of vandetanib and assess the relationship between PK and QT interval corrected for heart rate by the Bazett's method (QTc), measures of safety and efficacy and pharmacodynamic (PD) biomarkers. 6. To investigate plasma levels of the N-desmethyl and N-oxide metabolites of vandetanib in this patient population.

Outcome Measures

Primary Outcome Measures Progression-Free Survival (PFS) Median time (in weeks) from randomisation until objective disease progression or death Secondary Outcome Measures Overall Survival (OS) Objective Response Rate (ORR) Disease Control Rate (DCR) Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire: - Pain - Dyspnoea - Cough

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Vandetanib_study_57_ZEST_CSP_redacted_SECURE.pdf

CRF: blankcrf-d4200c00057.pdf

DATA DICTIONARY: DEID_docs+spec_57.zip

DATA (COMPARATOR ARM): Datasets_57.zip