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
Li-kun Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution