Clinical Research Directory

Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases

Sponsor: Cho Ray Hospital

Summary

The goal of this clinical trial is to learn whether adding stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (SRT), delivered on a linear accelerator (LINAC), to osimertinib improves control of brain metastases in adults with stage IV non-small cell lung cancer (NSCLC) carrying a sensitizing EGFR mutation (exon 19 deletion or exon 21 L858R) whose brain metastases cause neurological symptoms (present at diagnosis or arising during osimertinib treatment). The main questions it aims to answer are: * What proportion of participants achieve an intracranial objective response (complete or partial response by RANO-BM criteria)? * How long do participants live without intracranial or overall disease progression, how long do they live overall, and what side effects occur with the combined treatment? Participants will: * Take osimertinib 80 mg by mouth once daily (or continue it if they have already started it). * Receive SRS (1 fraction) or SRT (3 or 5 fractions) to all brain metastases (1 to 4 lesions, each 4 cm or smaller) at Cho Ray Hospital, Ho Chi Minh City, Vietnam. * Have brain MRI (or contrast-enhanced CT if MRI is not possible) and chest-abdomen CT every 12 weeks, monthly clinic visits to check for side effects, and blood tests, ECG and echocardiography every 12 weeks.

Official title: Osimertinib Combined With LINAC-Based Stereotactic Radiosurgery or Stereotactic Radiotherapy for Brain Metastases in EGFR-Mutant Stage IV Non-Small Cell Lung Cancer: A Prospective Single-Arm Interventional Study

Key Details

Conditions

Interventions

Locations (1)