Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT02575560
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2015-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2015-10-08', 'studyFirstSubmitQcDate': '2015-10-09', 'lastUpdatePostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival Time (PFS)', 'timeFrame': 'an average 1 year'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate(ORR)', 'timeFrame': 'an average half year'}, {'measure': 'Overall Survival Time (OS)', 'timeFrame': 'an average 2 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Progression-Free Survival'], 'conditions': ['EGFR-TKI Resistant Mutation']}, 'descriptionModule': {'briefSummary': 'EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.', 'detailedDescription': '1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'histological confirmed local advanced or metastatic lung adenocarcinoma with EGFR mutation diagnosed by 2nd generation sequence system.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.\n\nExclusion Criteria:\n\n* liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.'}, 'identificationModule': {'nctId': 'NCT02575560', 'briefTitle': 'Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Qingdao Central Hospital'}, 'officialTitle': 'High Dose Weekly Use First-generation EGFR-TKI Instead of Daily Regular Dose in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'QCH200501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'weekly use erolotinib vs history data', 'description': 'Drug: erolotinib erolotinib 1050mg, oral, once a week, continues to disease progression or death or stop by physician', 'interventionNames': ['Other: history data']}], 'interventions': [{'name': 'history data', 'type': 'OTHER', 'description': 'history data of PFS after 1st line or second line theray', 'armGroupLabels': ['weekly use erolotinib vs history data']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266042', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Qingdao Central Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'overallOfficials': [{'name': 'ketao lan', 'role': 'STUDY_CHAIR', 'affiliation': 'Qingdao Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qingdao Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Youxin Ji', 'investigatorAffiliation': 'Qingdao Central Hospital'}}}}