NCT07481786 Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases
| NCT ID | NCT07481786 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Lung Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2029-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 220 participants in total. It began in 2026-03-20 with a primary completion date of 2029-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07481786 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07481786 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 220 participants.
Is NCT07481786 currently recruiting?
Yes, NCT07481786 is actively recruiting participants. Contact the research team at liuhuisysucc@126.com for enrollment information.
Where is the NCT07481786 trial being conducted?
This trial is being conducted at Chongqing, China, Guangzhou, China, Guangzhou, China.
Who is sponsoring the NCT07481786 clinical trial?
NCT07481786 is sponsored by Sun Yat-sen University. The trial plans to enroll 220 participants.