Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT02272127
Status:
UNKNOWN
Last Update Posted:
2014-10-22
First Post:
2014-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C531470', 'term': 'icotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2014-09-27', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': 'from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Effects', 'timeFrame': 'duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EGFR tyrosine kinase inhibitor'], 'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing completely resection of EGRF mutation-positive NSCLC\n* Staging ⅠB (with high risk factor) to ⅢA\n* PS\\<2\n* Adequate hematological, biochemical and organ functions.\n\nExclusion Criteria:\n\n* Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT02272127', 'briefTitle': 'Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer', 'orgStudyIdInfo': {'id': 'NFEC-2014-069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intercalated treatment', 'description': 'Patients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects', 'interventionNames': ['Drug: icotinib']}], 'interventions': [{'name': 'icotinib', 'type': 'DRUG', 'armGroupLabels': ['intercalated treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kaican Cai, MD', 'role': 'CONTACT', 'email': 'doc_cai@163.com', 'phone': '8620-61641822'}], 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Kaican Cai, MD', 'role': 'CONTACT', 'email': 'doc_cai@163.com', 'phone': '8620-61641822'}, {'name': 'Siyang Feng, MM', 'role': 'CONTACT', 'email': 'fengsy89@163.com'}], 'overallOfficials': [{'name': 'Kaican Cai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician，Associate Professor', 'investigatorFullName': 'Kaican Cai', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}