Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02215356
Status:
UNKNOWN
Last Update Posted:
2014-08-13
First Post:
2014-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
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'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2014-08-11', 'studyFirstSubmitQcDate': '2014-08-11', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '36 months'}, {'measure': 'Objective response rate', 'timeFrame': '8 weeks'}, {'measure': 'Adverse events', 'timeFrame': '54 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer', 'detailedDescription': 'This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation\n* No previous systemic anticancer therapy\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* ECOG Performance Status of 0 to 1\n\nExclusion Criteria:\n\n* Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab\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'}, 'identificationModule': {'nctId': 'NCT02215356', 'briefTitle': 'Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Betta Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation', 'orgStudyIdInfo': {'id': 'BD-IC-IV66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chemoradiotherapy', 'description': 'Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily.', 'interventionNames': ['Drug: Chemoradiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Icotinib with concurrent radiotherapy', 'description': 'Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen.', 'interventionNames': ['Drug: Icotinib with concurrent radiotherapy']}], 'interventions': [{'name': 'Icotinib with concurrent radiotherapy', 'type': 'DRUG', 'otherNames': ['Icotinib', 'Comana', 'BPI-2009'], 'description': 'Icotinib: 125 mg is administered orally three times per day.', 'armGroupLabels': ['Icotinib with concurrent radiotherapy']}, {'name': 'Chemoradiotherapy', 'type': 'DRUG', 'otherNames': ['VP16', 'DDP'], 'description': 'Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles', 'armGroupLabels': ['Chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese Academy of Medical Sciences Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "People's Liberation Army 307 Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '523059', 'city': 'Dongguan', 'state': 'Guangdong', 'country': 'China', 'facility': "Dongguan City People's Hospital", 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen Cancer Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': "Guangxi Zhuang Autonomous Region People's Hospital", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Cancer Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Provincial Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Cancer Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '226361', 'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nantong Tumor Hospital', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '330029', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Jiangxi Provincial Cancer Hospital', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '130012', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Tumor Hospital of Jilin Province', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Liaoning Provincial Tumor Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030013', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Tumor Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichuan Provincial Tumor Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '830000', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '650118', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Tumor Hospital of Yunnan Province', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Lvhua Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, {'name': 'Xiaolong Fu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}