Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 5:27 AM
Study NCT ID:
NCT01646450
Status:
UNKNOWN
Last Update Posted:
2015-09-09
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C531470', 'term': 'icotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-05', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '12 months', 'description': 'PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '24 months', 'description': 'Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.'}, {'measure': 'Objective response rate', 'timeFrame': '3-6 months', 'description': 'Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety', 'timeFrame': '18 months', 'description': 'Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC', 'EGFR Mutation', 'Elder patients'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.', 'detailedDescription': 'A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.\n\n* Primary endpoint to assess progression-free survival\n* Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.\n* Positive EGFR Mutation.\n* No previous systemic anticancer therapy.\n* Male and female patients aged over 70 years.\n* Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).\n* Known severe hypersensitivity to icotinib or any of the excipients of this product.\n* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.'}, 'identificationModule': {'nctId': 'NCT01646450', 'briefTitle': 'First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Betta Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation', 'orgStudyIdInfo': {'id': 'BD-IC-IV20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Icotinib', 'description': 'Icotinib: 125mg, oral administration, three times per day.', 'interventionNames': ['Drug: Icotinib']}], 'interventions': [{'name': 'Icotinib', 'type': 'DRUG', 'otherNames': ['BPI-2009', 'Commana'], 'description': 'Icotinib: 125mg, oral administration, three times per day.', 'armGroupLabels': ['Icotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Han Baohui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}