Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-28 @ 2:30 PM
Study NCT ID:
NCT03940404
Status:
UNKNOWN
Last Update Posted:
2019-05-07
First Post:
2019-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anlotinib Therapy in Patients With Advanced Lung Cancer.
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-04', 'studyFirstSubmitDate': '2019-04-27', 'studyFirstSubmitQcDate': '2019-05-04', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '1 year', 'description': 'progression-free survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '1 year', 'description': 'overall survival'}, {'measure': 'ORR', 'timeFrame': '1 year', 'description': 'overall response rate'}, {'measure': 'DCR', 'timeFrame': '1 year', 'description': 'disease control rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Neoplasms']}, 'descriptionModule': {'briefSummary': 'Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world.\n\nSubjects of the study: advanced Lung cancer.\n\nMethods of the study:\n\nThis is a real world, prospective, Non-Interventional, Follow-up registration study.\n\nPatients will get Anlotinib according to their condition and willingness. Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. After the procedure, regular follow up after every cycle.\n\nEnd point:\n\nPrimary end point: progression-free survival (PFS). Secondary end points: overall survival (OS), disease control rate (DCR), overall response rate (ORR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'advanced lung caner', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment.\n2. Patients who had to have histologically and/or cytologically confirmed NSCLC that failed at least 2 kinds of systemic chemotherapy (third line or beyond), or who will obtain benefit from antiangiogenic therapy after investigator's assessment.\n3. Eastern Cooperative Oncology Group performance status of 0-2.\n\nExclusion Criteria:\n\n1. Contraindication of anlotinib.\n2. Pregnant or lactating women.\n3. Other patients who can't enroll after investigator's assessment."}, 'identificationModule': {'nctId': 'NCT03940404', 'briefTitle': 'Anlotinib Therapy in Patients With Advanced Lung Cancer.', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Anlotinib Hydrochloride Therapy in Patients With Advanced Lung Cancer: A Real World Study.', 'orgStudyIdInfo': {'id': 'ALOT-LC1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'experiment', 'description': 'The patients whose treatment strategy containing anlotinib.', 'interventionNames': ['Drug: Anlotinib Hydrochloride']}], 'interventions': [{'name': 'Anlotinib Hydrochloride', 'type': 'DRUG', 'otherNames': ["Other intervention depends on the patient's disease"], 'description': 'Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. Dose reduction is allowed.', 'armGroupLabels': ['experiment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueqin Chen', 'role': 'CONTACT', 'email': 'chenlucy1437@aliyun.com', 'phone': '+8613735430109'}, {'name': 'Xueqin Chen', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shenglin Ma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "First People's Hospital of Hangzhou", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xueqin Chen', 'role': 'CONTACT', 'email': 'chenlucy1437@aliyun.com', 'phone': '+8613735430109'}], 'overallOfficials': [{'name': 'Shenglin Ma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First People's Hospital of Hangzhou"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'collaborators': [{'name': 'Cttq', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}