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Lung (Non-Small Cell)

A Phase III, Randomized, Double-Blinded, Multi-Center Study to Assess the Efficacy of Docetaxel (TAXOTERE) in Combination with ZD6474 (ZACTIMA) versus Docetaxel (TAXOTERE) in combination with Placebo in Patients With Locally Advanced or Metastatic (Stage IIIb-IV) Non-small Cell Lung Cancer (NSCLC) after Failure of 1st Line Anti-Cancer Therapy

Unique Data Set IDLungNo_AstraZe_2006_163
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients1689Comparator (Control) Arm Enrolled Patients697RandomizationYesClinicalTrial.gov IDNCT00312377ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00312377
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypePlacebo, DrugData Set TypeSDTM

Clinical Trial Title

A Phase III, Randomized, Double-Blinded, Multi-Center Study to Assess the Efficacy of Docetaxel (TAXOTERE) in Combination with ZD6474 (ZACTIMA) versus Docetaxel (TAXOTERE) in combination with Placebo in Patients With Locally Advanced or Metastatic (Stage IIIb-IV) Non-small Cell Lung Cancer (NSCLC) after Failure of 1st Line Anti-Cancer Therapy

Trial Summary and Conditions

This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy. This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone. All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer. In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent. Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients. Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

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 objective The primary objective of this study was to demonstrate an improvement in PFS for the combination of vandetanib plus docetaxel (TAXOTERE) compared with docetaxel plus placebo in patients with locally-advanced or metastatic NSCLC after failure of 1st-line anticancer therapy. Secondary objectives The secondary objectives of the study were: 1. To demonstrate an improvement in OS for vandetanib in combination with docetaxel compared with docetaxel plus placebo. 2. To demonstrate an improvement in the overall objective response rate (ORR) (complete response [CR] + partial response [PR]), disease control rate (DCR) (CR + PR + stable disease [SD] ?6 weeks) and duration of response (DOR) for vandetanib in combination with docetaxel compared with docetaxel plus placebo as assessed by modified Response Evaluation Criteria in Solid Tumors (RECIST). 3. To demonstrate a beneficial effect on disease-related symptoms, in patients treated with vandetanib in combination with docetaxel, that is at least as good as that in patients treated with docetaxel plus placebo based on the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) lung cancer subscale (LCS). 4. To demonstrate a quality of life (QoL) for ZACTIMA in combination with docetaxel-treated subjects that is at least as good as that for subjects treated with docetaxel plus placebo by assessment of the FACT-L and the treatment outcome index (TOI). 5. To demonstrate an improvement in time to deterioration of disease-related symptoms (TDS) based on the FACT-L LCS for vandetanib in combination with docetaxel compared with docetaxel plus placebo. 6. To study the tolerability and safety of vandetanib in combination with docetaxel in patients with locally advanced or metastatic NSCLC after failure of 1st-line anti-cancer therapy. 7. To investigate the population pharmacokinetics (PK) of ZACTIMA in this patient population and assess the PK-QTc relationship, PK-safety relationship and PKefficacy

Outcome Measures

Primary Outcome Measures: Progression-Free Survival (PFS) in the Overall Population Progression-Free Survival (PFS) in the Female Population Secondary Outcome Measures: Overall Survival (OS) in the Overall Population Overall Survival (OS) in the Female Population Objective Response Rate (ORR) Disease Control Rate (DCR) Duration of Response (DoR) Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS). Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)

Available Downloads:

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

PROTOCOL: vandetanib_Study_32_ZODIAC_CSP_Redacted.pdf

CRF: blankcrf-d4200c00032.pdf

DATA DICTIONARY: DEID_docs+spec_32.zip

DATA (COMPARATOR ARM): Datasets_32.zip