Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-05 @ 10:15 PM
Study NCT ID:
NCT02140333
Status:
UNKNOWN
Last Update Posted:
2015-02-12
First Post:
2013-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2013-10-05', 'studyFirstSubmitQcDate': '2014-05-15', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 year after the initial dose'}, {'measure': 'Adverse events', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '2 years after the initial dose'}], 'secondaryOutcomes': [{'measure': 'The objective response rate', 'timeFrame': 'Patients will be followed for an expected average of 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['erlotinib', 'EGFR mutation'], 'conditions': ['NSCLC', 'EGFR Mutation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.', 'detailedDescription': 'In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological diagnosis of NSCLC with phase IIIB or IV disease;\n2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)\n3. Never received anti-tumor therapies for the advanced stage;\n4. Never used EGFR inhibitors;\n5. Measurable disease by RECIST criteria;\n6. Male or female patients \\>=18 years of age;\n7. ECOG karnofsky performance 0\\~3, life expectancy is greater than 12 weeks;\n8. Patients must be accessible for treatment and follow-up;\n\nExclusion Criteria:\n\n1. Previously used EGFR inhibitors\n2. Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;\n3. Allergic to erlotinib;\n4. Non-measurable lesions\n5. Pregnant or lactating women;\n6. Patients having other factors that preventing researchers from enrollment them.'}, 'identificationModule': {'nctId': 'NCT02140333', 'briefTitle': 'Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'FAHG20130819'}, 'secondaryIdInfos': [{'id': 'GZMC201301'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erlotinib 100mg', 'description': 'Erlotinib 100mg', 'interventionNames': ['Drug: Erlotinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erlotinib 150mg', 'description': 'Erlotinib 150mg', 'interventionNames': ['Drug: Erlotinib']}], 'interventions': [{'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['tarceva'], 'description': '100mg vs. 150mg', 'armGroupLabels': ['Erlotinib 100mg', 'Erlotinib 150mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guanzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianxing he, PhD', 'role': 'CONTACT', 'email': 'drjianxing.he@gmail.com', 'phone': '86-20-83062821'}, {'name': 'jianxing he, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangzhou medical university', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}], 'centralContacts': [{'name': 'jianxing He, PhD', 'role': 'CONTACT', 'email': 'drjianxing.he@gmail.com', 'phone': '86-20-83062821'}, {'name': 'yalei zhang, Dr.', 'role': 'CONTACT', 'email': 'yayazhang2004@163.com', 'phone': '86-20-83062821'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The First Affiliated Hospital of Guangzhou Medical Univers', 'investigatorFullName': 'Jianxing He', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}