Osimertinib plus focused radiation for EGFR-mutant lung cancer that has spread to the brain
Tests osimertinib with focused radiation in adults with EGFR-mutant lung cancer and brain metastases.
Plain-language title generated from the registry record
Registry title: Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases
Key facts
- Where
- Ho Chi Minh City, VietnamSee the site
- Phase
- Phase 2
Where in Vietnam
- Cho Ray Hospital - Department of Medical and Radiation Oncology, Oncology CenterHo Chi Minh City, VietnamTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cho Ray Hospital
- Trial code
- NCT07911449
- Record updated
- 2 November 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: Age 18 years or older; ECOG performance status 0-2; Histologically confirmed adenocarcinoma or squamous cell carcinoma of the lung, stage IV (AJCC 8th edition); Sensitizing EGFR mutation: exon 19 deletion or exon 21 L858R point mutation; Brain metastases diagnosed on contrast-enhanced MRI, CT or 18F-FDG PET-CT; Symptomatic brain metastases: brain metastases accompanied by neurological symptoms, either (a) present at diagnosis of brain metastases, or (b) arising while the patient is receiving osimertinib. Qualifying symptoms: raised intracranial pressure (headache, nausea/vomiting); focal neurological deficits (limb weakness or paralysis, sensory disturbance, visual disturbance, language disturbance, seizure, imbalance); cognitive-behavioural changes (memory or concentration decline, personality or mood change); 1 to 4 brain metastases, each 4 cm or smaller in maximum diameter; Written informed consent.
Exclusion: Prior stereotactic radiosurgery or whole-brain radiotherapy; History of a second malignancy; Prior treatment with a first- or second-generation EGFR-TKI; Pregnancy; Asymptomatic brain metastases (no neurological symptoms); Leptomeningeal metastases; Discontinuation of osimertinib before completing at least 3 months of treatment.