NCT06020066

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

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.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Metastases
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-10
• Primary completion: 2027-08-10
• Completion: 2028-08-10
• First posted: 2023-08-31
• Last updated: 2025-09-15

Locations

1 site across 1 country: China