This is a multicenter, phase II exploratory clinical trial in untreated patients with EGFR-mutant non-small cell lung cancer (stages IIIB-IV) .All participants will receive oral befotertinib monotherapy for 3 weeks first, then serial minimal residual disease (MRD/MRD) testing is performed to adjust subsequent treatment. Patients with positive MRD will receive 4 cycles of pemetrexed plus platinum chemotherapy; patients with negative MRD will continue single-agent befotertinib. After induction, maintenance therapy will be given according to follow-up MRD results. The primary goal is to evaluate progression-free survival guided by dynamic MRD monitoring, and secondary endpoints include objective response rate, disease control rate, safety and MRD clearance rate.
Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC).
Age ≥18 years, any gender.
Confirmed EGFR exon 19 deletion or exon 21 (L858R) substitution mutation by central laboratory or site-validated testing assay.
No prior systemic anti-tumor therapy.
Receiving other systemic anti-tumor therapy, or plan to combine other systemic anti-cancer agents during study.
Participated in another investigational drug trial within 4 weeks prior to first study drug; major surgery within 4 weeks; unhealed wound, active ulcer or fracture; radiotherapy within 2 weeks without recovery.
Severe cardiovascular disease: QTcF ≥450 ms or clinically significant ECG abnormality; uncontrolled hypertension (SBP>160 mmHg or DBP>100 mmHg); congestive heart failure, cardiomyopathy, arrhythmia requiring intervention, unstable angina, myocardial infarction, stroke or TIA within 6 months prior to treatment.
Uncontrolled active infection including active HBV, HCV, HIV, active syphilis infection judged by investigator. Stable infection without safety risk is permitted.
Guangzhou University of Traditional Chinese Medicine
Lead sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor institution
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Beijing Chest Hospital
Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator