Non-small cell lung cancer (NSCLC)
Conditions
Interventions
Treatment group:Befotertinib
Sponsors
Department of Thoracic Surgery, Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provide informed consent prior to any research specific procedure; (2) between the ages of 18 and 75 (including 18 and 75); 3. Histologically or cytologically confirmed lung adenocarcinoma on biopsies performed within 60 days prior to study enrollment; 4. Clinical stage IIA/IIB/IIIA/IIIB resectable lesions evaluated by EBUS-TBNA or PET/CT; 5. Test and confirm positive for EGFR mutation (must include exon 19 deletion or exon 21 L858R mutation); 6. The presence of at least one accurately measured lesion with a maximum diameter of =10mm on computed tomography (CT) at baseline (except for lymph nodes with a short axis =15mm) and suitable for accurate repeat measurements; 7. ECOG physical status is 0-1 points. 8. Hematology and liver and kidney function are suitable for perioperative targeted therapy; 1) Bone marrow: absolute neutrophil count (ANC) =1.5 × 109/L, platelet =100 × 109/L, hemoglobin =9 g /dl; 2) Liver: bilirubin =2 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=2.5 times the upper limit of normal; 3) Kidney: serum creatinine =1.5 times the upper limit of normal value or creatinine clearance =60 ml/min; 4) No malabsorption or other gastrointestinal disorders affecting drug absorption; 9. Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis); 10, At least 2 weeks before starting the investigational drug, the female subject should use highly effective contraception, the pregnancy test must be negative, and there must be no ongoing breastfeeding prior to starting the drug, or else one of the following criteria must be met at the time of screening that can demonstrate the possibility of no fertility: 1) Postmenopause is defined as amenorrhea over the age of 50 years and at least 12 years after stopping all exogenous hormone therapy A month. 2) Women under 50 should be considered to have stopped menstruating for 12 months or more after stopping exogenous hormone therapy and if LH and FSH levels are within the agency's postmenopausal range. 3) Irreversible surgical sterilization recorded by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation 11. Male subjects must be willing to use barrier contraception.
Exclusion criteria
Exclusion criteria: 1. Tumors with neuroendocrine components such as squamous cell carcinoma, large cell carcinoma or small cell carcinoma; 2. Exposure to other antitumor therapies before enrollment; 3.EGFR gene test showed 20 exon insertion mutations; 4. The patient is pregnant or breastfeeding; 5. Medications or herbal supplements that are currently receiving (or cannot be discontinued before receiving the first dose of investigational therapy) known to be potent inducers of CYP3A4 (at least 3 weeks ago). All patients should avoid concomitant use or ingestion of any medications, herbal supplements, and/or foods known to have an inducible effect on CYP3A4. 6. Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, any that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Chronic disease screening omission requirement; 7. Any of the following cardiac criteria: • QTc values obtained using the screening clinic electrocardiogram machine mean resting corrected QT interval (QTc) from 3 electrocardiogram (ECG) tests > 470 ms; • any clinically significant abnormality in the rhythm, conduction, or morphology of the resting ECG, such as left bundle branch block, third degree heart block, and second degree heart block; Any factors that increase the risk of prolonged QTc or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, sudden unexplained death under 40 years of age in a family history of long QT syndrome or first-degree relative, or any concomitant medications known to prolong the QT interval; 8. Any evidence of prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or active interstitial lung disease; 9. Lack of adequate bone marrow reserve or organ function (as demonstrated by any of the following laboratory values: absolute neutrophil count 2.5 times ULN; Aspartate aminotransferase >2.5 times ULN; Total bilirubin > 1.5x ULN; Serum creatinine >1.5 ULN with creatinine clearance 1.5 ULN); 10. A history of hypersensitivity to active or inactive excipients of befortinib or to drugs with a chemical structure or class similar to befortinib, as well as difficult to control nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated drugs, or major bowel resection that would have prevented adequate absorption of befortinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complications;Major pathologic response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR);Objective response rate (ORR);Disease control rate (DCR);R0 Surgical resection rate;Disease-free survival (DFS);Overall survival (OS);Adverse Events (AE); | — |
Countries
China
Contacts
Public ContactMu Hu
Department of Thoracic Surgery, Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed