Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-03-18 @ 7:06 AM
Study NCT ID:
NCT02407366
Status:
UNKNOWN
Last Update Posted:
2015-04-02
First Post:
2015-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy 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': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-03-30', 'lastUpdatePostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'One year', 'description': 'A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.'}], 'secondaryOutcomes': [{'measure': 'Overall survival(OS)', 'timeFrame': 'two years', 'description': 'Overall survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.'}, {'measure': 'Adverse events', 'timeFrame': 'two years', 'description': 'The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.'}, {'measure': 'Objective response rate', 'timeFrame': 'two years', 'description': 'Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.'}, {'measure': 'Quality of life', 'timeFrame': 'two years', 'description': 'Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inoperable stage III non-small cell lung cancer', 'EGFR mutation', 'Icotinib', 'Radiotherapy', 'Chemoradiotherapy'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR 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\n1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.\n2. No previous systemic anticancer therapy.\n3. life expectancy more than three months.\n4. ECOG Performance Status of 0 to 1.\n5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.\n6. Patients will be required to provide informed consent before enrollment.\n\nExclusion Criteria:\n\n1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.\n2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.\n3. Severe heart disease, uncontrolled diabetes mellitus, or active infection.\n4. Active concomitant malignancy, and pregnancy or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT02407366', 'briefTitle': 'Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Guangxi Zhuang Autonomous Region"}, 'officialTitle': 'A Phase 2 Study of Icotinib With Concurrent Radiotherapy vs. Pemetrexed+ Carboplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor ( EGFR) Mutation', 'orgStudyIdInfo': {'id': 'FGSLC-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Icotinib with concurrent radiotherapy', 'description': 'Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Icotinib', 'Radiation: Thoracic radiotherapy(TRT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemoradiotherapy', 'description': 'Pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy until disease progression or unacceptable toxicity .', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Carboplatin', 'Radiation: Thoracic radiotherapy(TRT)']}], 'interventions': [{'name': 'Icotinib', 'type': 'DRUG', 'otherNames': ['BPI-2009', 'Conmana'], 'description': 'Icotinib (125 mg ,Three times daily)', 'armGroupLabels': ['Icotinib with concurrent radiotherapy']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta', 'LY231514', 'MTA', 'Multitargeted Antifolate', 'NSC-698037'], 'description': 'Pemetrexed(500mg/m2)every 21 days', 'armGroupLabels': ['Chemoradiotherapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'Carboplatin (AUC，5) every 21 days', 'armGroupLabels': ['Chemoradiotherapy']}, {'name': 'Thoracic radiotherapy(TRT)', 'type': 'RADIATION', 'description': 'TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)', 'armGroupLabels': ['Chemoradiotherapy', 'Icotinib with concurrent radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'GuoSheng Feng, professor', 'role': 'CONTACT', 'email': 'fengguosheng88988@163.com', 'phone': '+86-771-218-6508'}], 'facility': "The people's Hospital of the Guangxi Zhuang Autonomous Region", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'centralContacts': [{'name': 'Xia Wu, intern', 'role': 'CONTACT', 'email': '353992578@qq.com', 'phone': '+86-185-789-52759'}, {'name': 'XiangLi Lai, intern', 'role': 'CONTACT', 'email': '249261276@qq.com', 'phone': '+86-138-7719-7891'}], 'overallOfficials': [{'name': 'GuoSheng Feng, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of Guangxi Zhuang Autonomous"}, {'name': 'Yuan Liang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangxi Department of Public Health'}, {'name': 'Lin Hui, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of Guangxi Zhuang Autonomous"}, {'name': 'HeMing Lu, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of Guangxi Zhuang Autonomous"}, {'name': 'ChangJie Huang, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Nanning Second People's Hospital"}, {'name': 'GuiSheng LI, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Liuzhou Workers' Hospital"}, {'name': 'HaiXin Huang, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Liuzhou Workers' Hospital"}, {'name': 'HaoLin Yan, MD', 'role': 'STUDY_CHAIR', 'affiliation': "First People's Hospital of Yulin"}, {'name': 'Ping Liang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangxi Ruikang Hospital'}, {'name': 'BingQiang Ni, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of LiuZhou"}, {'name': 'YanRong Hao, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of Guangxi Zhuang Autonomous"}, {'name': 'XianBin Yuan, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of Guangxi Zhuang Autonomous"}, {'name': 'Shan Gao, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of Guangxi Zhuang Autonomous"}, {'name': 'Xia Wu, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of Guangxi Zhuang Autonomous"}, {'name': 'XiangLi Lai, MD', 'role': 'STUDY_CHAIR', 'affiliation': "The People's hospital of Guangxi Zhuang Autonomous"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "People's Hospital of Guangxi Zhuang Autonomous Region", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guosheng Feng', 'investigatorAffiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}}}}