SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI
NCT ID: NCT06020066
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
202 participants
INTERVENTIONAL
2023-08-10
2028-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3rd generation EGFR-TKI+SRS
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.
EGFR-TK Inhibitor
Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.
Stereotactic radiotherapy
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.
3rd generation EGFR-TKI
The control group will receive 3rd generation EGFR-TKI until disease progression or intolerable toxicity occurs.
EGFR-TK Inhibitor
Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.
Interventions
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EGFR-TK Inhibitor
Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.
Stereotactic radiotherapy
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.
Eligibility Criteria
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Inclusion Criteria
* Clinical stage IV (AJCC, 8th edition, 2017);
* EGFR mutations: EGFR L858R, EGFR exon 19 deletion;
* Age ≥18 years;
* KPS score ≥70;
* Brain metastasis at the time of diagnosis;
* Complete baseline imaging assessment of metastatic lesions, including enhanced MRI for brain;
* Receiving first-line treatment with third-generation EGFR inhibitors;
* 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:
* No more than 10 remaining brain lesions;
* The maximum diameter of the remaining brain lesions does not exceed 3cm;
* At least one remaining brain lesion has a diameter greater than 5mm;
* After evaluation by the researcher, all remaining brain lesions are suitable for stereotactic radiotherapy.
* Patient informed consent.
Exclusion Criteria
* Patients withdrew their informed consent and requested to withdraw from the study;
* 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).
* Patients did not follow the protocol for follow-up visits as required by this study.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhengfei Zhu
Professor
Principal Investigators
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Zhengfei Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Xuwei Cai
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Qian Chu
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Xiaorong Dong
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lin Wu
Role: PRINCIPAL_INVESTIGATOR
Hunan Cancer Hospital
Rongrong Zhou
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Guang Han
Role: PRINCIPAL_INVESTIGATOR
Hubei Cancer Hospital
Hui Zhu
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Jinjun Ye
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Cancer Institute & Hospital
Xiaojia Cui
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Guomei Tai
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Zhiyong Yuan
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Dejun XIng
Role: PRINCIPAL_INVESTIGATOR
Jilin Provincial Tumor Hospital
Jichen Ren
Role: PRINCIPAL_INVESTIGATOR
Jilin Provincial Tumor Hospital
Jiancheng Li
Role: PRINCIPAL_INVESTIGATOR
Fujian Cancer Hospital
Yanyang Wang
Role: PRINCIPAL_INVESTIGATOR
General Hospital of Ningxia Medical University
Chuangzhou Rao
Role: PRINCIPAL_INVESTIGATOR
Ningbo No.2 Hospital
Bing Lu
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital Of Guizhou Medical University
Zhongyi Dong
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Jiwei Liu
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Zhenzhou Yang
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Chongqing Medical University
Hongqing Zhuang
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Anwen Liu
Role: PRINCIPAL_INVESTIGATOR
Nanchang University Second Affiliated Hospital
Haihua Yang
Role: PRINCIPAL_INVESTIGATOR
Taizhou Hospital Affiliated to Wenzhou Medical University
Fang Liu
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Yong Mao
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Jiangnan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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2306276-14
Identifier Type: -
Identifier Source: org_study_id
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