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.
Aged 18-75 years. ECOG performance status (PS) score of 0-2. Expected survival time of ≥3 months.
Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC).
Baseline evaluation confirming the presence of EGFR-sensitizing mutations (19del/L858R) via first- or second-generation sequencing. Test samples can include archived tumor tissue or fresh tumor tissue collected during screening. If unavailable, pleural effusion, cerebrospinal fluid, or blood samples may be used for testing.
Asymptomatic brain metastases or those with controlled intracranial hypertension symptoms following dehydration treatment. Continued medication to maintain stable symptoms at enrollment or during the study is allowed.
Active Bleeding with Brain and/or Leptomeningeal Metastases
Includes therapies with agents such as bevacizumab, endurance, or anlotinib.
≥ Grade 2 toxicity (NCI-CTCAE v4.03) related to prior treatments not resolved at the start of study treatment (excluding alopecia and Grade 2 neurotoxicity caused by platinum agents).
Includes uncontrolled nausea/vomiting, inability to swallow, gastrointestinal resection, chronic diarrhea, or intestinal obstruction
Single group
The treatment regimen is Furmonertinib combined with Bevacizumab.
DrugThe treatment regimen is Furmonertinib combined with Bevacizumab.
12-Month Intracranial Progression-Free Survival Rate Assessed by RECIST 1.1 in Patients with EGFR-Mutant NSCLC and Brain Metastases
The primary outcome measure is the 12-month intracranial progression-free survival (iPFS) rate, defined as the proportion of patients who remain free from intracranial disease progression or death due to any cause within 12 months from the initiation of treatment. Disease progression is assessed using the RECIST 1.1 criteria based on imaging studies, including enhanced brain MRI. Progression events are confirmed by independent radiological evaluation to ensure consistency and accuracy.
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Li-kun Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
