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

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.

Conditions

• Advanced Non-small Cell Lung Cancer (NSCLC)
• EGFR Exon 19 Deletion Mutation
• EGFR Exon 21 Mutation
• EGFR Exon 21 L858R Mutation

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Beijing Chest Hospital

  collaborator OTHER

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Guangzhou University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Xiaoshu Chai, MD · Guangdong Provincial Hospital of Traditional Chinese Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-05

Primary Completion

2030-07-31

Completion

2030-07-31

Countries

• China

Study Locations