Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT02974933
Status:
UNKNOWN
Last Update Posted:
2017-02-17
First Post:
2016-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous 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': 'D000068437', 'term': 'Pemetrexed'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-15', 'studyFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '4 weeks', 'description': 'evaluation per 28 days'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '4 weeks', 'description': 'evaluation per 28 days'}, {'measure': 'disease control rate', 'timeFrame': '4 weeks', 'description': 'evaluation per 28 days'}, {'measure': 'objective response rate', 'timeFrame': '4 weeks', 'description': 'evaluation per 28 days'}, {'measure': 'Adverse Event', 'timeFrame': '4 weeks', 'description': 'evaluation per 28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apatinib', 'pemetrexed', 'NSCLC'], 'conditions': ['Nonsmall Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival', 'detailedDescription': 'It is a one-arm study. The progression-free survival will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged from 18 years to 70years.\n2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV).\n3. Measurable lesions as defined by RECIST criteria.\n4. Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer\n5. ECOG performance status (PS) of 0 to 1.\n6. Life expectancy ≥3 months.\n7. Informed consent.\n\nExclusion Criteria:\n\n1. Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.\n2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.\n3. Tumor invade big vessels or close to big vessels (less than 5mm)\n4. Obvious cavity or necrosis formed in the tumor\n5. Uncontrolled hypertension\n6. Myocardial ischemia or infarction more than stage II, cardiac insufficiency.\n7. Abnormal coagulation (INR\\>1.5 or PT\\>ULN+4, or APTT\\>1.5 ULN), bleeding tendency or receiving coagulation therapy\n8. The active HBV or HCV infection\n9. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.\n10. Hemoptysis, more than 2.5ml daily\n11. Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.\n12. Unhealed bone fracture or wound for long time\n13. Received big surgery, had bone fracture or ulcer in 4 weeks.\n14. Urine protein≥++, or urine protein in 24 hours≥1.0g\n15. Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment\n16. Have received prior treatment with VEGFR TKI (Bevacizumab is permitted).\n17. Pregnant or lactating woman, or woman unwilling to practice contraception during the study.'}, 'identificationModule': {'nctId': 'NCT02974933', 'briefTitle': 'Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hubei Cancer Hospital'}, 'officialTitle': 'Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer ：Single Arm Exploratory Study', 'orgStudyIdInfo': {'id': 'HubeiCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'apatinib', 'description': 'combined with pemetrexed', 'interventionNames': ['Drug: Apatinib combined with pemetrexed']}], 'interventions': [{'name': 'Apatinib combined with pemetrexed', 'type': 'DRUG', 'description': 'For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression', 'armGroupLabels': ['apatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ou Wu ling, 40', 'role': 'CONTACT', 'email': '609700817@qq.com', 'phone': '13469989766', 'phoneExt': '86'}], 'facility': 'Ou wuling', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Ou Wu Ling, MD', 'role': 'CONTACT', 'email': '609700817@qq.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuling Ou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Hubei Clinical Research Collaboration Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician', 'investigatorFullName': 'Wuling Ou', 'investigatorAffiliation': 'Hubei Cancer Hospital'}}}}