Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01512420
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-12-19', 'studyFirstSubmitQcDate': '2012-01-13', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of overall survival with baseline clinical/demographic patient characteristics', 'timeFrame': 'approximately 2 years'}, {'measure': 'Correlation of overall survival with baseline tumour characteristics', 'timeFrame': 'approximately 2 years'}, {'measure': 'Correlation of overall survival with previous treatment regimens', 'timeFrame': 'approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR), tumour assessments according to RECIST criteria', 'timeFrame': 'approximately 2 years'}, {'measure': 'Disease control rate', 'timeFrame': 'approximately 2 years'}, {'measure': 'Progression-free survival', 'timeFrame': 'approximately 2 years'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 2 years'}]}, 'conditionsModule': {'conditions': ['Non-Squamous Non-Small Cell Lung Cancer']}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with previously treated advanced NSCLC, with wild-type EGFR gene or squamous cell carcinoma histology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)\n* Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:\n* squamous cell carcinoma lung cancer histology, and\n* current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of \\>15 pack-years of smoking\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva\n\nExclusion Criteria:\n\n* Current treatment with an investigational drug or participation in another investigational study\n* Severe 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\n* Clinically active interstitial lung disease\n* Recent myocardial infarction or unstable angina\n* Progressive or uncontrolled brain metastases'}, 'identificationModule': {'nctId': 'NCT01512420', '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, '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.', 'orgStudyIdInfo': {'id': 'ML27773'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '03600', 'city': 'Elda', 'state': 'Alicante', 'country': 'Spain', 'geoPoint': {'lat': 38.47783, 'lon': -0.79157}}, {'zip': '07703', 'city': 'Maó', 'state': 'Balearic Islands', 'country': 'Spain', 'geoPoint': {'lat': 39.88853, 'lon': 4.26583}}, {'zip': '07014', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '08006', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '10003', 'city': 'Cáceres', 'state': 'Caceres', 'country': 'Spain', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '17007', 'city': 'Girona', 'state': 'Girona', 'country': 'Spain', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '20080', 'city': 'Donostia / San Sebastian', 'state': 'Guipuzcoa', 'country': 'Spain', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '22300', 'city': 'Barbastro', 'state': 'Huesca', 'country': 'Spain', 'geoPoint': {'lat': 42.03565, 'lon': 0.12686}}, {'zip': '22004', 'city': 'Huesca', 'state': 'Huesca', 'country': 'Spain', 'geoPoint': {'lat': 42.13615, 'lon': -0.4087}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'La Coruña', 'country': 'Spain', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '26006', 'city': 'Logroño', 'state': 'La Rioja', 'country': 'Spain', 'geoPoint': {'lat': 42.46615, 'lon': -2.45115}}, {'zip': '35020', 'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'country': 'Spain', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '24071', 'city': 'León', 'state': 'Leon', 'country': 'Spain', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '27003', 'city': 'Lugo', 'state': 'Lugo', 'country': 'Spain', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28805', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28905', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '52005', 'city': 'Melilla', 'state': 'Malaga', 'country': 'Spain', 'geoPoint': {'lat': 35.29369, 'lon': -2.93833}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '37007', 'city': 'Salamanca', 'state': 'Salamanca', 'country': 'Spain', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '43204', 'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'state': 'Tenerife', 'country': 'Spain', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'zip': '44002', 'city': 'Teruel', 'state': 'Teruel', 'country': 'Spain', 'geoPoint': {'lat': 40.3456, 'lon': -1.10646}}, {'zip': '45004', 'city': 'Toledo', 'state': 'Toledo', 'country': 'Spain', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '41014', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46800', 'city': 'Xàtiva', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 38.99042, 'lon': -0.51852}}, {'zip': '47005', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '49021', 'city': 'Zamora', 'state': 'Zamora', 'country': 'Spain', 'geoPoint': {'lat': 41.50633, 'lon': -5.74456}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}