Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT02350361
Status:
UNKNOWN
Last Update Posted:
2015-01-29
First Post:
2015-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D043169', 'term': 'Endostatins'}, {'id': 'C522911', 'term': 'endostar protein'}], 'ancestors': [{'id': 'D043165', 'term': 'Angiostatic Proteins'}, {'id': 'D042501', 'term': 'Angiogenic Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D043170', 'term': 'Collagen Type XVIII'}, {'id': 'D024041', 'term': 'Non-Fibrillar Collagens'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-25', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-01-25', 'lastUpdatePostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Responese Rate', 'timeFrame': 'in two months'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'up to six months'}, {'measure': 'Overall Survial', 'timeFrame': 'follow up every two months, about two years'}, {'measure': 'Number of Serious Adverse Events', 'timeFrame': 'within two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endostar', 'angiogenesis', 'EGFR-TKI', 'lung caner'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.', 'detailedDescription': 'Lung cancer patients who received epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI) will acquiring resistance to the drug. This is a study of using Endostar, an angiogentic medicine, combination with chemotherapy and EGFR-TKI in lung cancer rechallenging treatment after resistance of EGFR-TKI and progression disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy.\n* Life expectancy of at least three (3) months after the start of administration of the investigational drug.\n* Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2.\n* Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and \\>=10 mm.\n* Patient received at least 6 months EGFR-TKI and show tumor progress\n* Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy\n* Patient signed consent form and adherence and geographic location are liable to follow up\n\nExclusion Criteria:\n\n* CNS metastasis\n* Active infection\n* Bleeding tendency or blood coagulation dysfunction\n* History of neurological or psychiatric disorders, including epilepsy, or dementia\n* Pregnancy or breast-feeding women\n* Organ transplant long-term use of immunosuppressive drugs\n* Arrhythmia need anti-arrhythmic treatment or other risk of heart disease\n* Use other targeted drugs during the research\n* Other conditions may not allowed to join in this study according to the researcher's judgment"}, 'identificationModule': {'nctId': 'NCT02350361', 'briefTitle': 'Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Study of Endostar Combination With Chemotherapy and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Lung Cancer Rechallenging Treatment After Resistance of EGFR-TKI and Tumor Progression', 'orgStudyIdInfo': {'id': 'PekingUTH-LL01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostar Arm', 'description': 'Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14', 'interventionNames': ['Drug: Recombinant human endostatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Arm', 'description': 'Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Recombinant human endostatin', 'type': 'DRUG', 'otherNames': ['Endostar'], 'description': 'Recombinant human endostatin 7.5mg/m2', 'armGroupLabels': ['Endostar Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Standard Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Liang, MD', 'role': 'CONTACT', 'phone': '13241870816'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Li Liang, MD', 'role': 'CONTACT', 'phone': '13241870816'}], 'overallOfficials': [{'name': 'Li Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate chief physician', 'investigatorFullName': 'Li Liang', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}