{ "FullStudy":{ "Rank":218124, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512420", "OrgStudyIdInfo":{ "OrgStudyId":"ML27773" }, "Organization":{ "OrgFullName":"Hoffmann-La Roche", "OrgClass":"INDUSTRY" }, "BriefTitle":"An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)", "OfficialTitle":"A Multicenter, Prospective, Observational Study to Identify Different Prognostic Factors Related to Survival in Patients With Previously Treated Advanced NSCLC With Wild-type Epidermal Growth Factor Receptor (EGFR) Gene." }, "StatusModule":{ "StatusVerifiedDate":"November 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 19, 2011", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 1, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 2, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Hoffmann-La Roche", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Non-Squamous Non-Small Cell Lung Cancer" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"355", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Cohort" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Correlation of overall survival with baseline clinical/demographic patient characteristics", "PrimaryOutcomeTimeFrame":"approximately 2 years" },{ "PrimaryOutcomeMeasure":"Correlation of overall survival with baseline tumour characteristics", "PrimaryOutcomeTimeFrame":"approximately 2 years" },{ "PrimaryOutcomeMeasure":"Correlation of overall survival with previous treatment regimens", "PrimaryOutcomeTimeFrame":"approximately 2 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Objective response rate (ORR), tumour assessments according to RECIST criteria", "SecondaryOutcomeTimeFrame":"approximately 2 years" },{ "SecondaryOutcomeMeasure":"Disease control rate", "SecondaryOutcomeTimeFrame":"approximately 2 years" },{ "SecondaryOutcomeMeasure":"Progression-free survival", "SecondaryOutcomeTimeFrame":"approximately 2 years" },{ "SecondaryOutcomeMeasure":"Safety: Incidence of adverse events", "SecondaryOutcomeTimeFrame":"approximately 2 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdult patients, >/= 18 years of age\nHistologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)\nPatients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:\nsquamous cell carcinoma lung cancer histology, and\ncurrent smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of >15 pack-years of smoking\nEastern Cooperative Oncology Group (ECOG) performance status 0 to 2\nPatients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva\n\nExclusion Criteria:\n\nCurrent treatment with an investigational drug or participation in another investigational study\nSevere or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin\nClinically active interstitial lung disease\nRecent myocardial infarction or unstable angina\nProgressive or uncontrolled brain metastases", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Patients with previously treated advanced NSCLC, with wild-type EGFR gene or squamous cell carcinoma histology", "SamplingMethod":"Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Trials", "OverallOfficialAffiliation":"Hoffmann-La Roche", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Vitoria", "LocationState":"Alava", "LocationZip":"01009", "LocationCountry":"Spain" },{ "LocationCity":"Elda", "LocationState":"Alicante", "LocationZip":"03600", "LocationCountry":"Spain" },{ "LocationCity":"Oviedo", "LocationState":"Asturias", "LocationZip":"33011", "LocationCountry":"Spain" },{ "LocationCity":"Santander", "LocationState":"Cantabria", "LocationZip":"39008", "LocationCountry":"Spain" },{ "LocationCity":"San Sebastian", "LocationState":"Guipuzcoa", "LocationZip":"20080", "LocationCountry":"Spain" },{ "LocationCity":"Barbastro", "LocationState":"Huesca", "LocationZip":"22300", 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