Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases
A legfontosabb adatok
- Ki végzi
- Cho Ray Hospital
- Hol
- Ho Chi Minh City (Vietnám)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Fázis
- 2. fázis
- Résztvevők
- 41 fő, tervezett
- Kezdés
- 2026. febr. 27.
- Várható befejezés
- 2029. dec. 31.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Osimertinib
- Stereotactic Radiosurgery
- A regiszteradat frissítve
- 2026. november 12.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with stage IV non-small cell lung cancer with an EGFR mutation and brain metastases that cause neurological symptoms. They take osimertinib plus targeted brain radiation (SRS or SRT).
- Életkor
- 18 years or older.
- Nem
- All sexes can join.
- A betegség stádiuma
- Stage IV (AJCC 8th edition) lung adenocarcinoma or squamous cell carcinoma, confirmed by tissue test. Must have 1 to 4 brain metastases, each 4 cm (1,6 in) or smaller, causing symptoms. Symptoms may be present at diagnosis or start during osimertinib. ECOG performance status 0-2 (able to care for yourself at least).
- Korábbi kezelés
- No prior first- or second-generation EGFR-TKI. No prior stereotactic radiosurgery or whole-brain radiotherapy. People already on osimertinib can join and continue it.
- Biomarker vagy leletérték
- Sensitizing EGFR mutation: exon 19 deletion or exon 21 L858R point mutation.
A részvétel fő kizáró okai
- History of a second cancer.
- Pregnancy.
- Brain metastases without neurological symptoms, or spread to the brain lining (leptomeningeal metastases).
- Prior first- or second-generation EGFR-TKI, stereotactic radiosurgery or whole-brain radiotherapy.
- Stopping osimertinib before completing at least 3 months of treatment.
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Helyszínek itt: Vietnám
- Cho Ray Hospital - Department of Medical and Radiation Oncology, Oncology CenterHo Chi Minh City, VietnámContact: Hung Ha Gia Nguyen, MD, MScRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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:
A teljes eredeti leírásKevesebb
* 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. * Health-related quality of life is evaluated with the EORTC QLQ-C30 and QLQ-BN20 before radiotherapy, at its completion, and 3 months later.
A vizsgálat csoportja
- Osimertinib + SRS/SRTA vizsgált kezelés
Osimertinib 80 mg orally once daily, started concurrently with or continued during SRS/SRT and continued until disease progression, unacceptable toxicity or withdrawal, plus LINAC-based stereotactic radiation to all brain metastases: 18 Gy in 1 fraction for lesions 2 cm or smaller; 27 Gy in 3 fractions or 30 Gy in 5 fractions for lesions larger than 2 cm.
Kezelés: Osimertinib és Stereotactic Radiosurgery
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
- A regiszteradat frissítve
- 2026. november 12.