lung cancer
Conditions
Interventions
Experimental group:For patients with EGFR-mutated non-small cell lung cancer in stages IIIB - IV, before local treatment, third-generation EGFR-TKI (befotertinib) therapy is implemented at a dose dete
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) gender-neutral, aged 18-75, able to understand and provide written informed consent; (2) subjects had non-small-cell lung carcinoma evidence of histological or cytologic adjudication, and patients with non-small-cell lung carcinoma disease had a clinical stage of stage IIIB-IV (staging according to the eighth edition of the American Joint Committee on Cancer) ; (3) IV was a stable solitary oligometastatic lesion (no more than 5 metastatic lesions and no more than 5 cm in size of single lesion) , controllable pleural effusion and stable brain metastatic lesions after radiotherapy (4) the subjects had not received EGFR-TKI before, or had been treated with first-generation and second-generation EGFR-TKI, the second test showed T790m positive, and the third-generation TKI was effective. (5) EGFR sensitive mutation phenotype was detected by gene test, or T790M was positive after EGFR-tki treatment (6) the expected survival time is more than 12 weeks; (7) ECOG PS 0-2; (8) compliance with research and follow-up procedures; (9) the level of organ function meets the following requirements: · haematological parameters: absolute neutrophil count =1.5 × 109L, platelet count =80 × 109L, hemoglobin =9.0 GDL (which can be maintained by blood transfusion) , normal clotting function; · liver function: total bilirubin =1.5 times the upper limit of normal, Alanine transaminase and aspartate transaminase =2.5 times the upper limit of normal, transaminase =5 times the upper limit of normal if liver metastases are present; Renal function: creatinine =1.25 times the upper limit of normal value, and creatinine clearance =60 ml/min; (10) prior to any study-related procedures, sampling and analysis, an informed consent is required to provide sufficient tissue/blood samples to meet the study requirements, the percentage of tumor cells in the tissue samples was not less than 20% .
Exclusion criteria
Exclusion criteria: (1) Patients intolerant to befotertinib; (2) Clinical staging of lung cancer is stage I, II, or IIIa; (3) Local lesions have previously received radiation therapy (excluding brain radiotherapy) or other local treatments such as radiofrequency; (4) Developed other malignant tumors within the past 5 years, excluding basal cell carcinoma that has been cured, cervical carcinoma in situ, localized prostate cancer treated with surgery, or breast ductal carcinoma in situ removed by surgery; (5) Patients have one or more of the following conditions: • Patients with symptomatic central nervous system metastasis or spinal compression; • Previous diagnosis of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormone therapy, or any other active interstitial lung disease with clinical evidence; baseline CT scan shows idiopathic pulmonary fibrosis; • Large pleural effusion or pericardial effusion (uncontrollable after treatment); • Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, liver, kidney, or metabolic disease); • Any significant ocular abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, severe exposure keratitis, or any other disease that may increase epithelial damage; • Unable to receive oral medication, require intravenous high-energy nutrition, previously undergone surgery that affects absorption, active gastrointestinal ulcers, chronic diarrhea; • Any clinical evidence indicating moderate to severe chronic obstructive pulmonary disease (COPD) (history of COPD or high-risk factors, pulmonary function test with FEV1/FVC <70%, FEV1 <80% predicted value, with or without chronic cough, phlegm, and shortness of breath symptoms), as well as other active pulmonary diseases determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;Event free survival, EFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Adverse event, AE; | — |
Countries
China
Contacts
Public ContactMing Dong
Tianjin Medical University General Hospital
Outcome results
None listed