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Lung (Non-Small Cell)

A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA) Versus Intravenous Docetaxel (TAXOTERE) in Patients With Locally Advanced or Metastatic Recurrent Non- Small Cell Lung Cancer who have Previously Received Platinum-Based Chemotherapy Study Short Name : INTEREST

Unique Dataset IDLungNo_AstraZe_2004_151ClinicalTrial.gov IDNCT00076388
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients1608Comparator (Control) Arm Enrolled Patients804RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeDrugDataset TypeOther

Clinical Trial Title

A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA) Versus Intravenous Docetaxel (TAXOTERE) in Patients With Locally Advanced or Metastatic Recurrent Non- Small Cell Lung Cancer who have Previously Received Platinum-Based Chemotherapy Study Short Name : INTEREST

Trial Summary and Conditions

The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.

Data Summary

Control arm data files include raw data on safety, efficacy ,demographics. Reporting database is also included. Patient data from countries ,Sweden, France and Germany were removed as we do not have consent to share the data.

Study Objectives

Primary To compare overall survival between ZD1839 and docetaxel Secondary To compare time to progression (TTP) between ZD1839 and docetaxel To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel To compare the overall objective tumor response rate between ZD1839 and docetaxel To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel

Outcome Measures

Overall Survival (OS), Time To Progression (TTP), Progression Free Survival (PFS), Overall Objective Response Rate (ORR), Quality of Life (QoL)

Available Downloads:

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

PROTOCOL: INTEREST Amended CSP_PDS.pdf

CRF: D791GC00001 Annotated CRF Main.pdf

DATA DICTIONARY: INTEREST FINAL Analysis.xls

DATA (COMPARATOR ARM): DE-IDENTIFIED DATASETS.zip

OTHER: D791GC00001 CRF FACT-L.pdf

OTHER: D791GC00001 CRF US GAC.pdf

OTHER: D791GC00001 CRF FLLCS.pdf