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

Recruiting
18 - 75 years of age
Both
Phase 2

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Overview

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.

Eligibility

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.

Study details

Brain Metastases, Non-small Cell Lung Cancer

NCT06020066

Fudan University

25 January 2024

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