Actively Recruiting
Evaluation of the Efficacy and Safety of Furmonertinib Combined with Bevacizumab As First-Line Treatment for EGFR-Positive Non-Small Cell Lung Cancer with Brain Metastases: a Single-Arm, Open-Label, Prospective Phase II Clinical Study
Led by Li-kun Chen · Updated on 2024-12-11
70
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the safety and efficacy of Befotertinib combined with Bevacizumab as a first-line treatment for patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) accompanied by brain or leptomeningeal metastases. It is a single-arm, open-label, prospective Phase II clinical trial aiming to explore the potential benefits of this combination therapy in improving intracranial progression-free survival (iPFS) and overall survival (OS). Patients will receive Befotertinib daily and Bevacizumab every three weeks until disease progression, intolerable toxicity, or withdrawal of consent. The study seeks to address the unmet need for effective treatments in this challenging patient population.
CONDITIONS
Official Title
Evaluation of the Efficacy and Safety of Furmonertinib Combined with Bevacizumab As First-Line Treatment for EGFR-Positive Non-Small Cell Lung Cancer with Brain Metastases: a Single-Arm, Open-Label, Prospective Phase II Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years with ECOG performance status score 0-2 and expected survival of at least 3 months
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
- EGFR-sensitizing mutations (19del/L858R) confirmed by first- or second-generation sequencing
- Presence of asymptomatic brain metastases or controlled intracranial hypertension symptoms
- At least one brain lesion of 5 mm or larger confirmed by MRI for brain metastases
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC
- Normal major organ function meeting specified hematology, biochemistry, coagulation, and heart function criteria
- Women of childbearing potential and male participants agree to use contraception during and 6 months after the study
- Voluntary informed consent and good compliance
You will not qualify if you...
- Active bleeding in brain or leptomeningeal metastases
- Prior therapies with agents such as bevacizumab, endurance, or anlotinib
- Unresolved Grade 2 or higher toxicity from prior treatments (except alopecia and certain neurotoxicity)
- Severe uncontrolled gastrointestinal conditions impairing oral intake
- Prior whole-brain radiotherapy or extensive recent radiation involving over 30% bone marrow
- Poorly controlled hypertension or significant cardiac abnormalities including arrhythmias and QT prolongation
- Active or uncontrolled severe infections and significant liver disease
- Poorly controlled diabetes with fasting glucose over 10 mmol/L
- Significant proteinuria or bleeding disorders
- History of recent thrombosis or severe hemoptysis
- Interstitial lung disease or steroid-requiring radiation pneumonitis
- Substance abuse or uncontrolled psychiatric disorders
- Poorly controlled pleural or ascitic effusions causing respiratory symptoms
- Known active infections including hepatitis B, hepatitis C, tuberculosis, syphilis, or HIV
- Severe conditions posing safety risks or impeding study completion
- Prior allogeneic bone marrow transplantation
- Major surgery within 28 days before first dose
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
L
li kun Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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