Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and Response Optimization in EGFR-mutated NSCLC Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
Befotinib: 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.
Pemetrexed + Cisplatin /Carboplatin: 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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Up to 48 months after the last participant enrollment,including at least 24 months of follow-up after the last participant is enrolled.
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.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | Not Yet Recruiting |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | Recruiting |
More Guangzhou University of Traditional Chinese Medicine trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07709585 on ClinicalTrials.gov ↗ ← All trials in China