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Lung (Non-Small Cell)

An Open Label, Randomised, Parallel Group, Multicentre, Phase III Study to Assess Efficacy, Safety and Tolerability of Gefitinib (IRESSA) (250mg tablet) Versus Carboplatin / Paclitaxel Doublet Chemotherapy as First-Line Treatment in Selected Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) in Asia Short Title : IPASS (Iressa Pan-Asia Study)

Unique Data Set IDLungNo_Astraze_2006_152
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients1328Comparator (Control) Arm Enrolled Patients664RandomizationYesClinicalTrial.gov IDNCT00322452ClinicalTrial.gov URLhttps://clinicaltrials.gov/show/NCT00322452
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeSDTM

Clinical Trial Title

An Open Label, Randomised, Parallel Group, Multicentre, Phase III Study to Assess Efficacy, Safety and Tolerability of Gefitinib (IRESSA) (250mg tablet) Versus Carboplatin / Paclitaxel Doublet Chemotherapy as First-Line Treatment in Selected Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) in Asia Short Title : IPASS (Iressa Pan-Asia Study)

Trial Summary and Conditions

The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.

Data Summary

Control Arm submitted in SDTM and ADaM standard. Demography , Safety , Efficacy, Biomarkers and QoL data are submitted

Study Objectives

Primary objective The primary objective of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients. Secondary objectives : -To compare the randomized treatment arms in terms of overall survival, and to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of: - Objective tumour response rate according to RECIST criteria - The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of carboplatin / paclitaxel doublet chemotherapy. - Quality of life as measured by the total score and Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy ? Lung Cancer (FACT-L) questionnaire - Symptom improvement as measured by the Lung Cancer Subscale (LCS) of the FACT-L questionnaire

Outcome Measures

Progression Free Survival (PFS), Overall Survival (OS), Objective Response Rate (ORR), Safety and tolerability, Quality of Life (QoL)

Available Downloads:

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

PROTOCOL: IPASS Revised CSP_Redacted1.pdf

CRF: IPASS_OS_blankCRF.pdf

DATA DICTIONARY: define_IPASS.pdf

DATA SUMMARY: IPASS_OS_ADAM_define.pdf

DATA (COMPARATOR ARM): De-identified datasets_OS.zip

DATA (COMPARATOR ARM): De_identified_IPASS_PFS_CUT.zip

OTHER: IPASS_OS_SDTM_define.pdf

OTHER: IPASS_PFS_ADAM_define.pdf

OTHER: IPASS_PFS_SDTM_define.pdf