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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Oral 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.
This 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.
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
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.
Time frame: Up to 48 months after the last participant enrollment,including at least 24 months of follow-up after the last participant is enrolled.
Median Overall Survival (OS)
Defined as the time from first dose of study treatment to death from any cause.
Time frame: Including at least 24 months of follow-up after the last participant is enrolled.Participants lost to follow-up will be censored at the last date they were known to be alive.
Objective response rate (ORR)
Defined as the proportion of participants achieving confirmed complete response (CR) or partial response (PR) per RECIST version 1.1.
Time frame: including at least 24 months of follow-up after the last participant is enrolled.
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 frame: including at least 24 months of follow-up after the last participant is enrolled.
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.
Time frame: Including at least 24 months of follow-up after the last participant is enrolled.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.