SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI (NCT06020066) | Clinical Trial Compass
Active — Not RecruitingPhase 2
SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI
China202 participantsStarted 2023-08-10
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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…