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

Fudan University

Status and phase: Active, not recruiting; Phase 2

Conditions: Brain Metastases; Non-small Cell Lung Cancer

Treatments: Radiation: Stereotactic radiotherapy; Drug: EGFR-TK Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06020066

2306276-14

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

3rd generation EGFR-TKI+SRS

Experimental group

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.

Treatment:

Drug: EGFR-TK Inhibitor

Radiation: Stereotactic radiotherapy

3rd generation EGFR-TKI

Active Comparator group

Description:

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

Treatment:

Drug: EGFR-TK Inhibitor