Locally advanced or metastatic non-small cell lung cancer with EGFR classical mutations
Conditions
Interventions
treatment group:Firmonertinib 160mg/d
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old and =3 months, isolated extracranial progression or intracranial progression, symptom score =10ng/ml (test time interval not less than 1 month), or blood CEA >=10ng/ml, gradually increasing for 2 consecutive tests (test time interval not less than 1 month); a) Symptom score: The symptom score is based on 5 indicators related to lung cancer: cough, hemoptysis, chest pain, fever, dyspnea, 0 without symptoms, 1 without symptom change, and 2 for symptom aggravation. b) Tumor burden score: represented by non-target lesion score: lesion progression, new intrathoracic lesion, new extrathoracic lesion, malignant pleural effusion, each of the four cases is 1 point, the total score is 4 points; 5. Patients with at least one measurable lesion and asymptomatic or stable brain metastases can be enrolled according to the Efficacy Evaluation Criteria in Solid Tumors (RECIST 1.1); 6. Laboratory tests show that the subject has adequate organ function: including: a) Absolute neutrophil value (ANC) >=1.5×10^9/L; Platelet count (PLT)>=100×10^9/L; Hemoglobin (HGB) >=90g/L; b) Serum total bilirubin (TBIL) =50 ml/min (according to the Cockcroft-Gault formula); 7. ECOG score 0~1 points; 8. Women of childbearing age who are not pregnant and have no pregnancy plan. Female subjects of childbearing age and male subjects agree to use effective contraception during the study and for 6 months after discontinuation; 9. Understand and voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.NSCLC with predominant squamous cell histology, small cell lung cancer or neuroendocrine carcinoma indicated by histology or cytology test; 2.Patients with other driver oncogenes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation, etc.); 3.Expected to receive other anti-tumor therapy other than the investigational product during the study; 4.Having received the following therapies: (a) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (b) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (c) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (d) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product; 5.Concurrent spinal cord compression or symptomatic brain metastasis; 6.The toxicity caused by previous anti-tumor therapy has not recovered to 470 ms on ECG at resting state; 12.Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval; for example, complete left bundle branch block, degree III atrioventricular block, congenital long QT syndrome, serious hypokalemia, or current use of drugs that may lead to prolonged QT interval; 13.Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product; 14.Infectious disease requiring intravenous medication; 15.Known history of mental dise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival according to RECIST 1.1 by investigator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Safety;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactZhuang Yu
The Affiliated Hospital of Qingdao University
Outcome results
None listed