Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-01 @ 6:36 AM
Study NCT ID:
NCT04833205
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2021-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055756', 'term': 'Meningeal Carcinomatosis'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C501466', 'term': 'nimotuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-04-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-18', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-04-03', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '2 years', 'description': 'From the diagnosis of the LM to the time of disease worsen'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '2 years', 'description': 'From the diagnosis of theLM to the time of death'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '8Weeks', 'description': 'When the Nimotuzumab is used,we will observe if the patients have the allergic reaction,diarrhea ,vomiting and so on.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leptomeningeal Metastasis', ',Nimotuzumab', 'Lung Cancer', 'EGFR-TKI'], 'conditions': ['Leptomeningeal Metastasis', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older, gender not limited;\n* A definite diagnosis of Leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging;\n* Have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis\n* Patients who received any of EGFR inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage\n* Detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed EGFR mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive EGFR expression\n* Bone marrow, liver, kidneys and blood clotting function are relatively stable\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group scored \\> 2 points\n* Patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study'}, 'identificationModule': {'nctId': 'NCT04833205', 'briefTitle': 'Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University'}, 'officialTitle': 'Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer', 'orgStudyIdInfo': {'id': 'BH005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leptomeningeal metastases received EGFR-TKI and Nimotuzumab', 'description': 'The patients received Nimotuzumab 200 mg,which was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping.And the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks.One the other hand,the patient received the third generation of EGFR-TKI', 'interventionNames': ['Drug: Nimotuzumab']}], 'interventions': [{'name': 'Nimotuzumab', 'type': 'DRUG', 'otherNames': ['EGFR-TKI'], 'description': 'Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks', 'armGroupLabels': ['Leptomeningeal metastases received EGFR-TKI and Nimotuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Hebei', 'state': 'Shijiazhuang/hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'hui bu, phd', 'role': 'CONTACT', 'email': 'buhuimy1@163.com', 'phone': '13831106903'}], 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 25.93504, 'lon': 116.17968}}, {'city': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'hui bu, phD', 'role': 'CONTACT', 'email': 'buhuimy1@163.com', 'phone': '13831106903'}], 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 25.93504, 'lon': 116.17968}}], 'centralContacts': [{'name': 'hui bu, PhD', 'role': 'CONTACT', 'email': 'buhuimy1@163.com', 'phone': '0311-66003711-211'}, {'name': 'jiao xue qi, master', 'role': 'CONTACT', 'email': '1074234012@qq.com'}], 'overallOfficials': [{'name': 'jiao xue qi, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Hebei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hui Bu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The department of neurology,clincial professor,director', 'investigatorFullName': 'Hui Bu', 'investigatorAffiliation': 'Hebei Medical University'}}}}