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.
Single group
Befotinib
DrugOral administration, initial dose 75 mg once daily; dose adjusted to 100 mg once daily based on safety and clinical benefit. Used as induction, single-agent maintenance, or combined with chemotherapy.
Pemetrexed + Cisplatin /Carboplatin
DrugThis is induction combination chemotherapy for MRD-positive patients after initial befotinib monotherapy. Pemetrexed at 500 mg/m² is given intravenously on Day 1 of each 21-day cycle, combined with either Cisplatin (75 mg/m² IV Day 1) or Carboplatin (AUC 5 IV Day 1) at investigator's discretion based on patient renal function and tolerability, for up to 4 cycles. Standard premedication with folic acid, vitamin B12 and dexamethasone is administered per pemetrexed prescribing guidelines.
Progression-Free Survival (PFS)
Time from first dose of study treatment to first radiographically confirmed isease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Median Overall Survival (OS)
Defined as the time from first dose of study treatment to death from any cause.
Objective response rate (ORR)
Defined as the proportion of participants achieving confirmed complete response (CR) or partial response (PR) per RECIST version 1.1.
Disease control rate (DCR)
defined as the proportion of participants achieving confirmed complete response (CR), partial response (PR) or stable disease (SD) per RECIST version 1.1.
Time to intolerable toxicity
Defined as the time from the first dose of study treatment to the first occurrence of treatment-related intolerable adverse event leading to permanent discontinuation of study therapy.
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options:
