lung cancer
Conditions
Interventions
The Furmonertinib Treatment Group:Oral Furmonertinib 80mg/day
Sponsors
The Second Affiliated Hospital of Army Medical University.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Able to comprehend and voluntarily sign the written informed consent form; 2. Male or female aged =18 years; 3. Diagnosed with multiple primary lung cancer according to the MM/ACCP clinical criteria, with preoperative chest CT scans revealing 2 or more ground-glass lesions that cannot be simultaneously resected (=6mm and <3cm, pure ground-glass or partially solid); 4. Have undergone surgical resection of the main lesion, with the main lesion testing positive for EGFR mutations (19del/L858R); 5. At least one suspected malignant (clinically diagnosed) ground-glass nodule (=6mm and <3cm) must be present after resection of the main lesion, and it cannot be simultaneously resected with the main lesion; 6. Preoperatively staged as cTis-T1c, N0, M0 according to AJCC 8th edition for included patients with multiple primary lung cancer; 7. ECOG performance status =1; 8. Laboratory examination results meet the following criteria: a) Absolute neutrophil count =1.5×10^9/L (excluding the use of growth factors in the 7 days prior to treatment initiation); b) Hemoglobin =90g/L (without blood transfusion or use of growth factors in the 10 days prior to treatment initiation); c) Platelet count =75×10^9/L; d) Serum total bilirubin =1.5×ULN (for patients with Gilbert's syndrome or those with liver metastases, total bilirubin =3×ULN and direct bilirubin =1.5×ULN are allowed); e) Serum ALT and AST =3×ULN (for patients with liver metastases, both ALT and AST =5×ULN); f) Creatinine clearance (Ccr) =60 mL/min, calculated using the Cockcroft-Gault equation: (140 - age [yr]) × weight (kg) × 1.23 × (0.85, if female) / serum creatinine (µmol/L); g) International normalized ratio (INR) =1.5×ULN; h) Asymptomatic serum amylase = Grade 2 (NCI-CTCAE v5.0). Patients with Grade 2 serum amylase abnormalities at the start of the study must have confirmation of no signs and/or symptoms suggestive of pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal pancreatic imaging results); i) Serum lipase =1.5×ULN; 9. Male participants of reproductive potential and women of childbearing potential (WOCBP) must agree to use effective contraception from the signing of the informed consent form until 3 months after the last dose of the investigational drug. Serum pregnancy test results for WOCBP must be negative within =7 days before the initiation of the study drug. Participants who have undergone sterilization or are postmenopausal are excluded. WOCBP refers to females who have experienced menarche but have not undergone menopause, with a duration of amenorrhea for =12 months in the absence of an alternative medical cause. Women who are permanently infertile due to sterilization procedures (such as removal of ovaries, fallopian tubes, and/or uterus) or other documented reasons as determined by the investigator (e.g., congenital absence of a uterus) are also excluded. The definition of reproductive potential may be adjusted according to local guidelines or regulations.
Exclusion criteria
Exclusion criteria: 1. MPLC with lymph node metastasis or distant metastasis; 2. Having other malignancies (excluding any type of in situ cancer, basal cell and squamous cell skin cancer, or other tumors/cancers that have been completely excised and have been disease-free for at least 3 years); 3. Require the use of strong inhibitors or strong inducers of the cytochrome P450 3A4 enzyme (CYP3A4) within 1 week before or during the study period of the first study drug (see Appendix 1); 4. Any serious or uncontrolled systemic diseases, including but not limited to: 1) Uncontrolled hypertension (refers to blood pressure>160/100 mmHg before screening or adjustment of antihypertensive drugs during screening period); 2) HIV(+), HCV-RNA (+), HBsAg positive and HBV-DNA=500IU/mL (If during the screening period, HBV-DNA decreases to less than 500IU/mL after antiviral therapy and persists for =2 weeks, it can be included in the study, but must continue antiviral therapy during the study period; for subjects who previously required antiviral therapy or screening who are currently receiving antiviral therapy, they must continue antiviral therapy throughout the study period to be included in the study); 3) Keratitis or active keratoconjunctivitis; 4) Active tuberculosis; 5) Any systemic infection treatment during the study period within 2 weeks before the first study drug administration; 6) Other severe diseases or mental illnesses that cannot be controlled by laboratory abnormalities, determined by the investigator as not suitable for patients with study drugs or affecting compliance; 5. Cardiac function and diseases meeting any of the following conditions: 1) At rest, based on the Fridericia formula, the average corrected QT interval (QTcF) on three ECGs during screening period is >470ms; 2) Any significant, such as ventricular arrhythmia, supraventricular arrhythmia, and other cardiac arrhythmias not controlled by medication (e.g., complete left bundle branch block, III degree atrioventricular block, II degree heart block, PR interval >250 msec); 3) Any risk factors that increase QTc prolongation, such as low potassium blood levels, genetic long QT syndrome, taking drugs that prolong QT interval (Appendix 2); 4) Chronic heart failure with NYHA classification =3 or ejection fraction<50% based on echocardiogram findings (Appendix 3); 6. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation-induced pneumonia requiring glucocorticoid therapy or currently undergoing drug treatment or ongoing clinical intervention, or presenting with current active interstitial lung disease; 7. Having coagulation dysfunction or bleeding tendency, including any venous thromboembolic events (including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolic history within 6 months before the first study drug administration), life-threatening bleeding events (including requiring blood transfusion therapy, surgical or local treatment, or continuous medication therapy), or lesions invading large vessels, determined by the investigator as having bleeding tendency; 8. Dysphagia or having active digestive system diseases or undergoing major digestive tract surgery that may significantly affect the intake and absorption of the study drug (e.g., ulcerative lesions, inability to swallow drugs, uncontrolled nausea, vomiting, diarrhea, and absorp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lesion response rate;Safety; | — |
Countries
China
Contacts
Public ContactJigang Dai
Second Affiliated Hospital of the Army Medical University
Outcome results
None listed