Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02595450
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2015-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 years', 'description': 'Analysis population included participants who received at least 1 documented treatment cycle.', 'eventGroups': [{'id': 'EG000', 'title': 'Erlotinib', 'description': "Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.", 'otherNumAtRisk': 291, 'otherNumAffected': 134, 'seriousNumAtRisk': 291, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 123}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Diffuse alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': "Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files."}], 'classes': [{'categories': [{'measurements': [{'value': '4.87', 'groupId': 'OG000', 'lowerLimit': '4.07', 'upperLimit': '5.90'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 years', 'description': 'Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who received at least 2 documented treatment cycles.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': "Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files."}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '15.14', 'groupId': 'OG000'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '63.76', 'groupId': 'OG000'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '12.39', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 years', 'description': 'Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than \\[\\<\\] 10 millimeter \\[mm\\]). No new lesions. PR was defined as greater than or equal to (\\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who received at least 2 documented treatment cycles. Missing data was not reported.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': "Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not evaluable because as per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 years', 'description': 'Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'As per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erlotinib', 'description': "Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Unspecified (only completed 1 cycle)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'Enrolled, but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': "It was physician's decision to prescribe erlotinib in participants and to document their treatment cycles."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Erlotinib', 'description': "Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '172', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included participants who received at least 1 documented treatment cycle.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2015-11-02', 'resultsFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-17', 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Time', 'timeFrame': 'Up to 6 years', 'description': 'Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.'}, {'measure': 'Percentage of Participants With Best Overall Response', 'timeFrame': 'Up to 6 years', 'description': 'Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than \\[\\<\\] 10 millimeter \\[mm\\]). No new lesions. PR was defined as greater than or equal to (\\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) Time', 'timeFrame': 'Up to 6 years', 'description': 'Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.'}]}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '86 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with locally advanced or metastatic NSCLC that are planned to receive erlotinib containing regimen according to label will be included in this trial.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* It is the physician's decision to prescribe erlotinib in participants and to document their treatment\n* Participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label\n\nExclusion Criteria:\n\n* Participants will be excluded if safety concerns occurred\n* If the participant was not compliant or if the participant would wish to stop erlotinib therapy"}, 'identificationModule': {'nctId': 'NCT02595450', 'briefTitle': 'A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Non Interventional Trial of Tarceva Metastatic Non Small Lung Cancer.', 'orgStudyIdInfo': {'id': 'ML22190'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Erlotinib', 'description': "Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.", 'interventionNames': ['Drug: Erlotinib']}], 'interventions': [{'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': "Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.", 'armGroupLabels': ['Erlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6712', 'city': 'Bludesch', 'country': 'Austria', 'geoPoint': {'lat': 47.2, 'lon': 9.73306}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}