ctDNA Monitoring Guides the Treatment of NSCLC With Befotertinib Combined With Radiotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Medical University Fourth Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-75 years at the time of signing the informed consent form, both males and females are eligible;
Histologically confirmed newly diagnosed or treatment-naïve oligometastatic stage IV NSCLC (AJCC 9th edition) with ≤3 involved organs and ≤5 metastatic lesions. Regional lymph node involvement (regardless of number) is not counted as metastatic sites; non-regional lymph node involvement is classified as a metastatic lesion;
Presence of an EGFR sensitizing mutation (19Del or 21L858R);
At least one measurable lesion according to RECIST v1.1;
Disqualifiers
Small cell lung cancer or non-small cell lung cancer mixed with histologic types such as small cell lung cancer or neuroendocrine carcinoma;
Confirmed EGFR exon 20 insertion mutation or non-classical mutations such as L861Q, G719X, or S768I;
Prior systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., standard chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc.);
Patients with symptomatic brain metastases, carcinomatous meningitis, or spinal cord compression, or imaging (CT or MRI) findings of brain or leptomeningeal disease at screening (except those with previously treated brain metastases who have been stable and without progression for ≥4 weeks before enrollment, and confirmed by brain MRI, CT, or venography to have no evidence of intracranial hemorrhage);
Trial design
Treatments tested in this trial
- Befotertinib
Treatment groups
84 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov