Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and Response Optimization in EGFR-mutated NSCLC Patients

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.

NCT Number	NCT07709585
Lead Sponsor	Guangzhou University of Traditional Chinese Medicine Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Chest Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Sichuan Cancer Hospital and Research Institute, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, First Affiliated Hospital of Xinjiang Medical University
Conditions	Advanced Non-small Cell Lung Cancer (NSCLC), EGFR Exon 19 Deletion Mutation, EGFR Exon 21 Mutation, EGFR Exon 21 L858R Mutation
Enrollment	124 participants
Start Date	2026-07-05
Primary Completion	2030-07-31 (estimated)
Study Completion	2030-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-16