Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-01-25 @ 1:44 AM
Study NCT ID:
NCT01990261
Status:
TERMINATED
Last Update Posted:
2016-09-16
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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-La Roche'}, '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 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.', 'otherNumAtRisk': 33, 'otherNumAffected': 3, 'seriousNumAtRisk': 33, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Ischaemic limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia of malignant disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pleural neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival Rate at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Survival Rate at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '101.0', 'groupId': 'OG000', 'lowerLimit': '55.194', 'upperLimit': '146.806'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From inclusion up to disease progression or death whichever occurs first (up to 6 months)', 'description': 'PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '121.0', 'groupId': 'OG000', 'lowerLimit': '62.862', 'upperLimit': '179.138'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From inclusion up to disease progression or death whichever occurs first (up to 12 months)', 'description': 'PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.788', 'spread': '20.823', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months', 'description': 'OS is defined as time from first administration of study drug until death from any cause.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival According to Prior Chemotherapy Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'classes': [{'title': 'Carboplatin & Gemcitabine (n=7)', 'categories': [{'measurements': [{'value': '191.857', 'spread': '41.756', 'groupId': 'OG000'}]}]}, {'title': 'Nabelvina & Carboplatin (n=1)', 'categories': [{'measurements': [{'value': '80.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Carboplatin (n=1)', 'categories': [{'measurements': [{'value': '138.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Carboplatin & Alimta (n=1)', 'categories': [{'measurements': [{'value': '63.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Carboplatin & Vinorelbine (n=1)', 'categories': [{'measurements': [{'value': '440.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Carboplatin & Docetaxel (n=2)', 'categories': [{'measurements': [{'value': '222.500', 'spread': '113.500', 'groupId': 'OG000'}]}]}, {'title': 'Carboplatin & Paclitaxel (n=4)', 'categories': [{'measurements': [{'value': '184.875', 'spread': '81.771', 'groupId': 'OG000'}]}]}, {'title': 'Docetaxel, Gemcitabine & Cisplatin (n=1)', 'categories': [{'measurements': [{'value': '135.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cisplatin & Paclitaxel (n=2)', 'categories': [{'measurements': [{'value': '268.000', 'spread': '61.000', 'groupId': 'OG000'}]}]}, {'title': 'Docetaxel (n=1)', 'categories': [{'measurements': [{'value': '115.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Gemcitabine (n=1)', 'categories': [{'measurements': [{'value': '30.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Gemzar & Carboplatine (n=3)', 'categories': [{'measurements': [{'value': '127.667', 'spread': '39.725', 'groupId': 'OG000'}]}]}, {'title': 'Paclitaxel & carboplatin (CBDCA) (n=1)', 'categories': [{'measurements': [{'value': '80.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Taxol & Carboplatin (n=1)', 'categories': [{'measurements': [{'value': '314.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Taxotere (n=1)', 'categories': [{'measurements': [{'value': '336.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months', 'description': 'Prior chemotherapy treatment is presented as reported by the investigators.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Death Before Treatment Start', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death due to Disease Progression (PD)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Death From other Causes', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Disease Progression (PD)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'PD Before Treatment Start', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Dossier not Approved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 33 participants were enrolled in 13 centers in Romania.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'From 18 to 60 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': '60 years and older', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all enrolled participants.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-08', 'studyFirstSubmitDate': '2013-10-31', 'resultsFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-17', 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Rate at Month 6', 'timeFrame': 'Month 6'}, {'measure': 'Survival Rate at Month 12', 'timeFrame': 'Month 12'}, {'measure': 'Progression Free Survival (PFS) at Month 6', 'timeFrame': 'From inclusion up to disease progression or death whichever occurs first (up to 6 months)', 'description': 'PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.'}, {'measure': 'Progression Free Survival (PFS) at Month 12', 'timeFrame': 'From inclusion up to disease progression or death whichever occurs first (up to 12 months)', 'description': 'PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 12 months', 'description': 'OS is defined as time from first administration of study drug until death from any cause.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 12 months', 'description': 'An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Overall Survival According to Prior Chemotherapy Treatment.', 'timeFrame': 'Up to 12 months', 'description': 'Prior chemotherapy treatment is presented as reported by the investigators.'}]}, 'conditionsModule': {'conditions': ['Non-Squamous Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants diagnosed with locally advanced, metastatic or recurrent non-small cell lung carcinoma with wild-type EGFR.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>/= 18 years\n* Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.\n* At least one failed chemotherapy treatment.\n\nExclusion Criteria:\n\n\\- Unknown EGFR mutation status'}, 'identificationModule': {'nctId': 'NCT01990261', 'acronym': 'STAR', 'briefTitle': 'A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'The Survival of Non-Small Cell Lung Carcinoma EGFR Non-mutated (Wild Type) Patients Treated With Erlotinib (TARceva) After the Failure of at Least One Chemotherapy Regimen', 'orgStudyIdInfo': {'id': 'ML28496'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Erlotinib', 'description': 'Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.', 'interventionNames': ['Drug: Erlotinib']}], 'interventions': [{'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': 'Erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.', 'armGroupLabels': ['Erlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '022338', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}