SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Pathologically confirmed non-small cell lung cancer; - 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:

- Poor compliance with the study protocol in the investigator's opinion; - 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06020066
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fudan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zhengfei Zhu, MDXuwei CaiQian ChuXiaorong DongLin WuRongrong ZhouGuang HanHui ZhuJinjun YeXiaojia CuiGuomei TaiZhiyong YuanDejun XIngJichen RenJiancheng LiYanyang WangChuangzhou RaoBing LuZhongyi DongJiwei LiuZhenzhou YangHongqing ZhuangAnwen LiuHaihua YangFang LiuYong Mao
Principal Investigator Affiliation	Fudan UniversityShanghai Chest HospitalTongji HospitalWuhan Union Hospital, ChinaHunan Cancer HospitalXiangya Hospital of Central South UniversityHubei Cancer HospitalShandong Cancer Hospital and InstituteJiangsu Cancer Institute & HospitalThe Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, ChinaThe Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, ChinaTianjin Medical University Cancer Institute and HospitalJilin Provincial Tumor HospitalJilin Provincial Tumor HospitalFujian Medical University Cancer HospitalGeneral Hospital of Ningxia Medical UniversityNingbo No.2 HospitalThe Affiliated Hospital Of Guizhou Medical UniversityNanfang Hospital, Southern Medical UniversityThe First Affiliated Hospital of Dalian Medical UniversityThe Second Affiliated Hospital of Chongqing Medical UniversityPeking University Third HospitalNanchang University Second Affiliated HospitalTaizhou Hospital Affiliated to Wenzhou Medical UniversityChinese PLA General HospitalAffiliated Hospital of Jiangnan University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Non-small Cell Lung Cancer

Arms & Interventions

Arms

Experimental: 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.

Active Comparator: 3rd generation EGFR-TKI

The control group will receive 3rd generation EGFR-TKI until disease progression or intolerable toxicity occurs.

Interventions

Drug: - EGFR-TK Inhibitor

Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.

Radiation: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Status

Recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, 200030

Site Contact

Zhengfei Zhu, MD

[email protected]

+8618017312901

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