Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-05 @ 6:10 PM
Study NCT ID:
NCT03652857
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'Approximately 1 years', 'description': "To measure the patients's overall response rate"}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'Approximately 1 years', 'description': 'Progression free survival'}, {'measure': 'OS', 'timeFrame': 'Approximately 1 years', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Apatinib plus Vinorelbine', 'NSCLC'], 'conditions': ['Advanced Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '32191330', 'type': 'DERIVED', 'citation': 'Zhang X, Xiong Y, Xia Q, Wu F, Liu L, Zhou Y, Zeng L, Zhou C, Xia C, Jiang W, Liao D, Xiao L, Liu L, Yang H, Guan R, Li K, Wang J, Lei G, Zhang Y, Yang N. Efficacy and Safety of Apatinib Plus Vinorelbine in Patients With Wild-Type Advanced Non-Small Cell Lung Cancer After Second-Line Treatment Failure: A Nonrandomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201226. doi: 10.1001/jamanetworkopen.2020.1226.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Posterior Advanced Non-small Cell Lung Cancer', 'detailedDescription': "This efficacy and safety research plan to explore the use of Apatinib combined with Vinorelbine to driven gene mutation negative three line and three line later non-small cell lung cancer.According to the result of TAX317,the investigators expect the effective rate is 20% and 80% of degree of assurance.Single arm bilateral experiment's sample size is calculated 27, according to 10% censoring,the expected sample size is 30."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18，Pathologically proven non small cell lung cancer\n\n * Adenocarcinoma，No-drive gene mutaion (EGFR、ALK、ROS1） by NGS\n * Squamous cell carcinoma，no gene detection\n * Progress after second line\n * PS score \\>2\n\nExclusion Criteria:\n\n* Patients received apatinib or Vinorelbine treatment before\n* EGFR, ALK or ROS1 mutation\n* Patients with contraindication of chemotherapy\n* Pregnant or breast feeding women'}, 'identificationModule': {'nctId': 'NCT03652857', 'briefTitle': 'Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'the Effectiveness and Safety Study on Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'VICTOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apatinib Combined With Vinorelbine', 'description': 'Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer', 'interventionNames': ['Drug: Apatinib Combined With Vinorelbine']}], 'interventions': [{'name': 'Apatinib Combined With Vinorelbine', 'type': 'DRUG', 'description': 'Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months', 'armGroupLabels': ['Apatinib Combined With Vinorelbine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Provincal Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Nong Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Province Tumor Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yongchang Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}