A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Cancer Hospital

About this trial

Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC

Eligibility criteria

Qualifiers

Sign a written informed consent before implementing any trial-related procedures;

At least 18 years of age;

Have histologically or cytologically confirmed non-squamous non-small cell lung cancer.

Confirmed presence of EGFR-sensitive mutation-positive by tumor histology, cytology, hematology, or pleural effusion supernatant;

Disqualifiers

The pathology is small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and non-small cell lung cancer (NSCLC);

received systemic anti-tumor therapy within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine therapy with anti-tumor indications), etc.;

received any investigational drug therapy within 4 weeks before treatment;

received high-dose immunosuppressive drugs (systemic glucocorticoids exceeding 10mg/day of prednisone or its equivalent dose) within 4 weeks before treatment;

Trial design

Treatments tested in this trial

  • Firmonertinib
  • Firmonertinib/pemetrexed/Carboplatin
  • Firmonertinib/pemetrexed/Carboplatin/Bevacizumab

Treatment groups

154 Participants
are divided into 4 treatment groups