Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
Study NCT ID:
NCT02726568
Status:
UNKNOWN
Last Update Posted:
2019-02-19
First Post:
2016-03-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], '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'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531470', 'term': 'icotinib'}]}}, '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': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-15', 'studyFirstSubmitDate': '2016-03-29', 'studyFirstSubmitQcDate': '2016-03-31', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by NCI-CJ-CAE3.0', 'timeFrame': 'from date of randomization until the date of death, assessed up to 2 months.'}], 'primaryOutcomes': [{'measure': 'intracranial progression-free survival', 'timeFrame': 'from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.'}], 'secondaryOutcomes': [{'measure': 'progress-free survival', 'timeFrame': 'from date of randomization until the date of extracranial progression, assessed up to 18 months.'}, {'measure': 'overall survival', 'timeFrame': 'from date of randomization until the date of death, assessed up to 36 months.'}, {'measure': 'objective response rate', 'timeFrame': 'from date of randomization until the date of progression, assessed up to 12 months.'}, {'measure': 'disease control rate', 'timeFrame': 'from date of randomization until the date of progression, assessed up to 18 months.'}, {'measure': 'Quality of life measured by FACT-L/LCS 4.0 and FACT-Br', 'timeFrame': 'from date of randomization until the date of death from any cause, assessed up to 36 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EGFR-TKI', 'NSCLC', 'Icotinib', 'SRS', 'radiotherapy'], 'conditions': ['Non-small Cell Lung Cancer', 'Brain Metastases']}, 'descriptionModule': {'briefSummary': 'This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases.', 'detailedDescription': 'The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits to brain metastases patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological confirmation of non-small cell lung cancer (NSCLC);\n* Diagnosis of brain metastases on a Gadolinium-enhanced MRI.\n* Less than 10 sites of intracranial metastases, or the longest diameter of the intracranial lesion is less than 4cm.\n* Positive EGFR mutation（Ex19del or 21L858R）.\n* Life expectancy ≥3months.\n* Have one or more measurable encephalic lesions according to RECIST.\n* The patient has not received radiotherapy for the head or extracranial target lesions before.\n* Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.\n* Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min.\n* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \\< 2.5 x ULN in the absence of liver metastases, or \\< 5 x ULN in case of liver metastases.\n* Female subjects should not be pregnant.\n* All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.\n* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.\n* Allergic to Icotinib.\n* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.\n* Pregnancy or breast-feeding women.\n* Participate in the other anti-tumor clinical trials in 4 weeks.\n* have quit from the trail before.\n* Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.'}, 'identificationModule': {'nctId': 'NCT02726568', 'briefTitle': 'High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Betta Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase II Study to Determine the Efficacy and Safety of High Dose Icotinib Combined With Stereotatic Radiosurgery for NSCLC Patients Harboring EGFR Mutation With Brain Metastases', 'orgStudyIdInfo': {'id': 'BD-IC-IV-65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Icotinib 375mg Tid', 'description': 'The human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction.', 'interventionNames': ['Drug: Icotinib', 'Radiation: SRS']}], 'interventions': [{'name': 'Icotinib', 'type': 'DRUG', 'description': '375 mg Tid (1125 mg per day) until intracranial PD.', 'armGroupLabels': ['Icotinib 375mg Tid']}, {'name': 'SRS', 'type': 'RADIATION', 'description': 'If intracranial PD, then the subjects get stereotatic radiosurgery （30Gy/3f) combined with Icotinib 375mg Tid.', 'armGroupLabels': ['Icotinib 375mg Tid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YOU LU, M.D.', 'role': 'CONTACT'}, {'name': 'YOU LU, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'YOU LU, M.D.', 'role': 'CONTACT', 'email': 'radyoulu@163.com', 'phone': '0086-28-85423571'}], 'overallOfficials': [{'name': 'YOU LU, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}