Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases

NCT07481786 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Phase 3

Started

2026-03-20

Last updated

2026-04-06

Condition(s) studied

Lung AdenocarcinomaBrain MetastasesRadiotherapy, Intensity-ModulatedBevacizumabWhole-Brain Radiotherapy

Investigational drug(s) / intervention(s)

FSRTHA-WBRT-SIBBevacizumab

FSRT: 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).

HA-WBRT-SIB: 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.

Bevacizumab: 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.

Study summary

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 .

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Intracranial Progression-Free Survival (IPFS) — 18 months
Defined as the time from randomization to the first documentation of intracranial progression, death, or last follow-up.
Neurocognitive Function failure — 6 months
Neurocognitive failure is the first failure, defined as a neurocognitive decline using the reliable change index (RCI) on at least one of the following assessments: HVLT-R, TMT, or COWA

Trial sites (3)

Facility	City	Region	Status
The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Recruiting
Sun yat-sen University Cancer Center	Guangzhou	Guangdong	Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong	Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07481786 on ClinicalTrials.gov ↗ ← All trials in China