Stereotactic radiotherapy for brain metastases in lung cancer patients

Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Oligo-residual Intracranial Disease After First-line Third-generation EGFR Inhibitors: a Multicenter, Randomized Clinical Trial.

This study is testing if a special type of radiation therapy can help lung cancer patients with brain metastases feel better while they are on targeted medication.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06020066 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of stereotactic radiotherapy in patients with non-small cell lung cancer (NSCLC) who have oligo-residual intracranial disease after receiving first-line third-generation EGFR inhibitors. Participants must have a confirmed diagnosis of NSCLC with specific EGFR mutations and meet certain imaging criteria for brain metastases. The study aims to determine how well this treatment can manage remaining brain lesions while the patient is on targeted therapy. The approach combines advanced imaging techniques and targeted radiotherapy to potentially improve outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed stage IV non-small cell lung cancer and specific EGFR mutations who have limited brain metastases.

Not a fit: Patients with extensive brain metastases or those who have progressed on third-generation EGFR inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing brain metastases in lung cancer patients, potentially improving survival and quality of life.

How similar studies have performed: Other studies have shown promising results with stereotactic radiotherapy for brain metastases, indicating that this approach is supported by prior research.

Eligibility 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.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Zhengfei Zhu, MD — Fudan University
• Study coordinator: Zhengfei Zhu

Conditions Brain Metastases; Non-small Cell Lung Cancer