NCT07911449RecruitingPhase 2
Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- First submitted
- 21 Oct 2026
- Start date
- 27 Feb 2026
- Primary completion date
- 30 Oct 2028
- Lead sponsor
- Cho Ray Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07911449
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 41
- From 27 Feb 2026 to the primary completion date, 30 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior stereotactic radiosurgery or whole-brain radiotherapy.
Other illness
- History of a second malignancy.
Lab values
- Prior treatment with a first- or second-generation EGFR-TKI.
Other
- Pregnancy.
- Asymptomatic brain metastases (no neurological symptoms).
- Leptomeningeal metastases.
- Discontinuation of osimertinib before completing at least 3 months of treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cho Ray Hospital - Department of Medical and Radiation Oncology, Oncology Center Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.