NCT07410611

ctDNA Monitoring Guides the Treatment of NSCLC With Befotertinib Combined With Radiotherapy

Dynamic ctDNA Monitoring Guides a Single-Arm, Multicenter, Exploratory Study of Befotertinib Combined With Radiotherapy for EGFR-Mutated Oligometastatic NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Befotertinib is a third-generation EGFR-TKI independently developed in China. In first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR mutations, it has demonstrated a median progression-free survival (PFS) of 22.1 months, representing the longest reported PFS data among currently available third-generation EGFR-TKIs. Building on the clinical advantages of this agent and addressing the unmet therapeutic needs in oligometastatic NSCLC, this study aims to conduct a prospective exploration by dynamically monitoring circulating tumor DNA (ctDNA) to guide the application of befotertinib combined with radiotherapy in patients with EGFR mutation-positive oligometastatic NSCLC.

Conditions

• Patients With Advanced Oligometastatic Non-small Cell Lung Cancer (NSCLC) Who Have Tested Positive for EGFR Mutations Confirmed by Histopathological Examination

Interventions

Type	Name	Description
DRUG	Befotertinib	Subjects will receive treatment with Befotertinib. Peripheral blood will be collected 8 weeks (±7 days) later for ctDNA testing. Those who test positive for ctDNA will undergo treatment intensification with Befotertinib combined with radiotherapy, while those who test negative will continue with Befotertinib monotherapy.

Timeline

• Start date: 2026-02-10
• Primary completion: 2030-02-28
• Completion: 2030-02-28
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: China