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Taking people in ChinaPhase 3

Bevacizumab with focused radiation versus whole-brain radiation for lung cancer in the brain

Compares two brain radiation plans for adults with lung cancer spread to the brain.

Key facts

Who runs it
Sun Yat-sen University
Where
Chongqing and Guangzhou, ChinaSee the 3 sites
Trial code
Registry title
Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases
Status
Recruiting
Phase
Phase 3
People taking part
220 people, planned
Started
20 Mar 2026
Expected to end
15 Sept 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • FSRT
  • HA-WBRT-SIB
  • Bevacizumab
Record updated
6 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with lung adenocarcinoma that has spread widely to the brain. It compares two brain radiation treatments.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Non-squamous non-small cell lung cancer (adenocarcinoma), confirmed by a tissue test. Extensive brain metastases: 1-2 metastases with at least one ≥3 cm (1.2 in); or 3-10 metastases with at least one ≥2 cm (0.8 in); or 11-20 metastases. Cancer outside the brain is stable.
Earlier treatment
No earlier radiotherapy to the brain and no surgery to remove brain metastases.

Main reasons for not taking part

  • Cannot take bevacizumab (for example uncontrolled high blood pressure, past bleeding or blood clots, recent surgery)
  • Cancer spread to the membranes around the brain (leptomeningeal metastasis)
  • Brain tumor pressure needing urgent brain surgery
  • Severe heart, blood vessel or gut disease within 6 months
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Age ≥18 years
  • Pathologically confirmed non-squamous non-small cell lung cancer (adenocarcinoma)
  • Extensive brain metastases meeting any of the following:; 1-2 metastases with at least one ≥3 cm in diameter; or 3-10 metastases with at least one ≥2 cm; or 11-20 metastases
  • Stable extracranial disease
  • ECOG performance status 0-2
  • Adequate bone marrow, hepatic, and renal function
  • Written informed consent

Who cannot take part

  • Prior brain radiotherapy or surgical resection of brain metastases
  • Contraindications to bevacizumab (uncontrolled hypertension, history of bleeding/thromboembolism, recent surgery, etc.)
  • Severe cardiovascular, vascular, or gastrointestinal disease within 6 months
  • Other active malignancies (except curable non-melanoma skin cancer or cervical carcinoma in situ)
  • Leptomeningeal metastasis
  • Significant mass effect requiring urgent neurosurgical intervention
  • Proteinuria ≥3+ or 24-hour urine protein >1 g
  • Inability to comply with neurocognitive testing
  • Pregnancy or breastfeeding

Where in China

  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaContact: Rui Zhou, DoctorTaking people
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Hui LiuTaking people
  • The First Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou, ChinaContact: Linzhu Zhai, DoctorTaking people

About the trial

What the trial wants to find out

This is a phase 3, randomized, controlled clinical trial comparing two brain-directed treatment strategies for adult patients with extensive brain metastases from lung adenocarcinoma. The trial compares fractionated stereotactic radiotherapy combined with bevacizumab (FSRT-Bev) versus hippocampus-avoidant whole-brain radiotherapy with simultaneous integrated boost (HA-WBRT-SIB). The main objectives are to evaluate intracranial tumor control and preservation of neurocognitive function .

Read full original descriptionShow less

Patients will be randomly assigned in a 1:1 ratio to receive either FSRT plus bevacizumab or HA-WBRT-SIB. In the experimental group, FSRT is delivered to visible brain tumors over 5 daily treatments (total 30 Gy, 6 Gy per fraction). Bevacizumab is given intravenously every 3 weeks for 4 cycles. In the control group, patients receive hippocampus-avoidant whole-brain radiation (25 Gy) with a simultaneous dose boost to metastatic lesions (40 Gy total) over 10 daily treatments.

The 2 groups in the trial

  • The FSRT-beva groupTreatment being tested

    The FSRT-bevacizumab group receives FSRT plus bevacizumab. FSRT targets visible intracranial lesions, with a total dose of 30 Gy administered once daily for 5 fractions (6 Gy per fraction). Bevacizumab is initiated one week before the start of FSRT and administered every 3 weeks for a total of 4 cycles, via intravenous injection at a dose of 7.5 mg/kg.

    Treatment: FSRT and Bevacizumab

  • The HA-WBRT-SIB groupExisting treatment, for comparison

    The HA-WBRT-SIB group receives whole-brain radiotherapy with hippocampal avoidance and a simultaneous integrated boost (SIB) to visible intracranial lesions. A total dose of 25 Gy is delivered to the whole brain, while visible lesions are simultaneously boosted to 40 Gy. Treatment is administered once daily for a total of 10 fractions.

    Treatment: HA-WBRT-SIB

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Application of Bevacizumab Combined With Fractionated Stereotactic Radiotherapy (FSRT-Bev) Versus Hippocampus-Avoidant Whole-Brain Radiotherapy With Simultaneous Integrated Boost (HA-WBRT-SIB) in Patients With Extensive Brain Metastases From Lung Adenocarcinoma: A Phase III Randomized Controlled Trial Evaluating Intracranial Control Efficacy and Neurocognitive Function
Plain-language title
Bevacizumab with focused radiation versus whole-brain radiation for lung cancer in the brainGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 April 2026