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
New trial compares two radiation therapies plus Bevacizumab for lung cancer brain metastases
Plain English Summary
Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases is a Phase 3 clinical trial sponsored by Sun Yat-sen University studying Lung Adenocarcinoma, Brain Metastases, Radiotherapy, Intensity-Modulated, Bevacizumab, Whole-Brain Radiotherapy. This trial tests two different radiation therapy approaches combined with a drug called Bevacizumab to see which is better at controlling brain tumors and preserving thinking abilities in patients with lung cancer that has spread to the brain. It is for adults diagnosed with lung adenocarcinoma that has spread extensively to the brain. Participation involves being randomly assigned to one of two treatment groups, receiving either a specific type of radiation therapy with Bevacizumab or another type of radiation therapy. It also includes regular check-ups and thinking tests. Alternative treatments might include surgery for brain tumors, other types of radiation therapy, or different drug combinations, depending on the individual patient's situation and doctor's recommendation. The trial aims to enroll 220 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of lung adenocarcinoma that has spread to the brain. Patients must have a specific number and size of brain tumors, stable disease outside the brain, and be able to perform daily activities with some assistance. Individuals with uncontrolled high blood pressure, a history of bleeding problems, recent surgery, or certain other serious medical conditions may not be eligible. People with cancer spread to the spinal fluid (leptomeningeal metastasis), prior radiation to the brain, or those unable to complete thinking tests are also excluded. This trial is studying Lung Adenocarcinoma, Brain Metastases, Radiotherapy, Intensity-Modulated, Bevacizumab, Whole-Brain Radiotherapy, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how well the treatments stop brain tumors from growing (intracranial progression-free survival) and how well patients maintain their thinking and memory abilities over tim The specific primary outcome measures are: Intracranial Progression-Free Survival (IPFS) (18 months); Neurocognitive Function failure (6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a critical need for better treatments that control brain tumors from lung cancer while protecting cognitive function, a common challenge for patients with this condition. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Lung Adenocarcinoma, Brain Metastases, Radiotherapy, Intensity-Modulated, Bevacizumab, Whole-Brain Radiotherapy, where improved treatment options are needed.
Investor Insight
This Phase 3 trial, comparing a novel combination therapy against a standard approach, signals a significant investment in improving outcomes for a large patient population, with potential for broad m Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor about the specific radiation techniques being used, the potential side effects of both radiation and Bevacizumab, and how your thinking abilities will be monitored. Participation involves regular clinic visits for treatment, scans to check tumor response, and cognitive tests to assess brain function. Be prepared for potential side effects such as fatigue, nausea, headaches, and changes in blood pressure, and discuss any concerns with your medical team. This trial is currently recruiting participants. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 220 participants
Interventions
- RADIATION: 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).
- RADIATION: 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.
- DRUG: 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.
Primary Outcomes
- Intracranial Progression-Free Survival (IPFS) (18 months)
- Neurocognitive Function failure (6 months)
Secondary Outcomes
- Progression-Free Survival (PFS) (18 months)
- Overall Survival (OS) (18 months)
- Quality of Life Assessment (18 months)
- Safety Assessment (18 months)
Full 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
Trial Locations
- The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
- Sun yat-sen University Cancer Center, Guangzhou, Guangdong, China
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
Frequently Asked Questions
What is clinical trial NCT07481786?
NCT07481786 is a Phase 3 INTERVENTIONAL study titled "Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases." It is currently recruiting and is sponsored by Sun Yat-sen University. The trial targets enrollment of 220 participants.
What conditions does NCT07481786 study?
This trial investigates treatments for Lung Adenocarcinoma, Brain Metastases, Radiotherapy, Intensity-Modulated, Bevacizumab, Whole-Brain Radiotherapy. The primary condition under study is Lung Adenocarcinoma.
What treatments are being tested in NCT07481786?
The interventions being studied include: FSRT (RADIATION), HA-WBRT-SIB (RADIATION), Bevacizumab (DRUG). 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).
What does Phase 3 mean for NCT07481786?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07481786?
This trial is currently "Recruiting." It started on 2026-03-20. The estimated completion date is 2029-09-15.
Who is sponsoring NCT07481786?
NCT07481786 is sponsored by Sun Yat-sen University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07481786?
The trial aims to enroll 220 participants. The trial is currently recruiting and accepting new participants.
How is NCT07481786 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07481786?
The primary outcome measures are: Intracranial Progression-Free Survival (IPFS) (18 months); Neurocognitive Function failure (6 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07481786 being conducted?
This trial is being conducted at 3 sites, including Chongqing, Chongqing Municipality; Guangzhou, Guangdong (China).
Where can I find official information about NCT07481786?
The official record for NCT07481786 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07481786. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07481786 testing in simple terms?
This trial tests two different radiation therapy approaches combined with a drug called Bevacizumab to see which is better at controlling brain tumors and preserving thinking abilities in patients with lung cancer that has spread to the brain. It is for adults diagnosed with lung adenocarcinoma that has spread extensively to the brain.
Why is this trial significant?
This trial addresses a critical need for better treatments that control brain tumors from lung cancer while protecting cognitive function, a common challenge for patients with this condition. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07481786?
Potential side effects of radiation include fatigue, hair loss in the treated area, and cognitive changes. Bevacizumab can cause high blood pressure, bleeding, blood clots, and problems with wound healing. There is a risk of temporary or permanent changes in memory, concentration, and other thinking abilities. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07481786?
Ask your doctor about the specific radiation techniques being used, the potential side effects of both radiation and Bevacizumab, and how your thinking abilities will be monitored. Participation involves regular clinic visits for treatment, scans to check tumor response, and cognitive tests to assess brain function. Be prepared for potential side effects such as fatigue, nausea, headaches, and changes in blood pressure, and discuss any concerns with your medical team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07481786 signal from an investment perspective?
This Phase 3 trial, comparing a novel combination therapy against a standard approach, signals a significant investment in improving outcomes for a large patient population, with potential for broad m This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves being randomly assigned to one of two treatment groups, receiving either a specific type of radiation therapy with Bevacizumab or another type of radiation therapy. It also includes regular check-ups and thinking tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.