Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-03 @ 11:08 PM
Study NCT ID:
NCT06020066
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Two years', 'description': 'PFS was measured from the date of randomization to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Three years', 'description': 'OS was defined as the time from the date of randomization until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.'}, {'measure': 'Intracranial progression-free survival', 'timeFrame': 'Two years', 'description': 'iPFS was defined as the time from the start of randomization to the occurrence of intracranial disease progression or death. If the subject first experiences extracranial disease progression (without concurrent intracranial disease progression), the date of first extracranial disease progression will be used as the cut-off date. For patients who have not progressed at the time of analysis, the date of their last contact will be used as the cut-off date.'}, {'measure': 'Health-related quality of life per QLQ-C30', 'timeFrame': 'Two years', 'description': 'Health-related quality of life was evaluated using the QLQ-C30 questionnaires to assess health-related quality of life.'}, {'measure': 'Health-related quality of life per QLQ-LC13', 'timeFrame': 'Two years', 'description': 'Health-related quality of life was evaluated using the QLQ-LC13 questionnaires to assess health-related quality of life.'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Two years', 'description': 'Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Metastases', 'Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically confirmed non-small cell lung cancer;\n* Clinical stage IV (AJCC, 8th edition, 2017);\n* EGFR mutations: EGFR L858R, EGFR exon 19 deletion;\n* Age ≥18 years;\n* KPS score ≥70;\n* Brain metastasis at the time of diagnosis;\n* Complete baseline imaging assessment of metastatic lesions, including enhanced MRI for brain;\n* Receiving first-line treatment with third-generation EGFR inhibitors;\n* After 3-6 months of third-generation EGFR inhibitor treatment, imaging review indicates no progression of extracranial lesions, and brain lesions are evaluated by thin-layer (1mm layer) enhanced MRI, meeting the following criteria:\n\n * No more than 10 remaining brain lesions;\n\n * The maximum diameter of the remaining brain lesions does not exceed 3cm;\n\n * At least one remaining brain lesion has a diameter greater than 5mm;\n\n * After evaluation by the researcher, all remaining brain lesions are suitable for stereotactic radiotherapy.\n* Patient informed consent.\n\nExclusion Criteria:\n\n* Poor compliance with the study protocol in the investigator's opinion;\n* Patients withdrew their informed consent and requested to withdraw from the study;\n* Patients were unable to receive regular doses of third-generation EGFR inhibitors due to other underlying conditions, viral side effects, economic factors, etc. (e.g., continuous discontinuation for more than 1 week, cumulative discontinuation for more than 2 weeks).\n* Patients did not follow the protocol for follow-up visits as required by this study."}, 'identificationModule': {'nctId': 'NCT06020066', 'briefTitle': 'SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Oligo-residual Intracranial Disease After First-line Third-generation EGFR Inhibitors: a Multicenter, Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '2306276-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3rd generation EGFR-TKI+SRS', 'description': 'The experimental arm will undergo stereotactic radiotherapy targeting all residual lesions in the brain (completed in a single or multiple treatment courses within one month), while continuing EGFR-TKI therapy until disease progression or intolerable toxicity occurs.', 'interventionNames': ['Drug: EGFR-TK Inhibitor', 'Radiation: Stereotactic radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3rd generation EGFR-TKI', 'description': 'The control group will receive 3rd generation EGFR-TKI until disease progression or intolerable toxicity occurs.', 'interventionNames': ['Drug: EGFR-TK Inhibitor']}], 'interventions': [{'name': 'EGFR-TK Inhibitor', 'type': 'DRUG', 'description': 'Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.', 'armGroupLabels': ['3rd generation EGFR-TKI', '3rd generation EGFR-TKI+SRS']}, {'name': 'Stereotactic radiotherapy', 'type': 'RADIATION', 'description': 'Patients with oligo-residual intracranial disease after treatment with EGFR-TKI will be treated with SRS of all intracranial lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist.', 'armGroupLabels': ['3rd generation EGFR-TKI+SRS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhengfei Zhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'Xuwei Cai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}, {'name': 'Qian Chu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}, {'name': 'Xiaorong Dong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, {'name': 'Lin Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Cancer Hospital'}, {'name': 'Rongrong Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangya Hospital of Central South University'}, {'name': 'Guang Han', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hubei Cancer Hospital'}, {'name': 'Hui Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Cancer Hospital and Institute'}, {'name': 'Jinjun Ye', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Cancer Institute & Hospital'}, {'name': 'Xiaojia Cui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China'}, {'name': 'Guomei Tai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China'}, {'name': 'Zhiyong Yuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}, {'name': 'Dejun XIng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jilin Provincial Tumor Hospital'}, {'name': 'Jichen Ren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jilin Provincial Tumor Hospital'}, {'name': 'Jiancheng Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Cancer Hospital'}, {'name': 'Yanyang Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Ningxia Medical University'}, {'name': 'Chuangzhou Rao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ningbo No.2 Hospital'}, {'name': 'Bing Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital Of Guizhou Medical University'}, {'name': 'Zhongyi Dong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}, {'name': 'Jiwei Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Dalian Medical University'}, {'name': 'Zhenzhou Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}, {'name': 'Hongqing Zhuang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}, {'name': 'Anwen Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanchang University Second Affiliated Hospital'}, {'name': 'Haihua Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taizhou Hospital Affiliated to Wenzhou Medical University'}, {'name': 'Fang Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}, {'name': 'Yong Mao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Jiangnan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhengfei Zhu', 'investigatorAffiliation': 'Fudan University'}}}}