Study of Befotertinib as Additional Treatment After Surgery in Patients With Stage IA2-IB Non-small Cell Lung Cancer Having MRD and High-Risk Factors

What this Trial Is About

Researchers are evaluating 3-year disease-free survival in patients with early-stage non-small cell lung cancer NSCLC who have minimal residual disease MRD positive for EGFR-sensitive mutations after surgery. The study compares the outcomes of patients treated with adjuvant befortinib, an oral third-generation epidermal growth factor receptor tyrosine-kinase inhibitor, against those under routine observation. This prospective trial focuses on patients with high-risk factors following complete tumor removal in stages IA2 to IB NSCLC. Participants receive befortinib as an adjuvant therapy after surgery, or they are monitored under routine observation without additional treatment. The study includes patients who have undergone R0 resection with specific tumor sizes and confirmed EGFR mutations, along with at least two high-risk pathological features. Treatment details include oral befortinib administration during the adjuvant period, with follow-up to assess disease progression. During the study, participants undergo MRD screening and regular follow-up visits to monitor their health status and disease-free survival over three years. Researchers assess outcomes such as disease recurrence and survival rates, alongside safety and organ function tests. Participants must comply with scheduled evaluations and provide informed consent, with the study duration extending up to three years to evaluate long-term disease-free outcomes.

Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients