Non-small cell lung cancer
Conditions
Interventions
Group A:Furmonertinib 80mg QD
Group B:Furmonertinib 160mg QD
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years; 2. Patients with histologically or cytologically confirmed unresectable stage IV NSCLC; 3. More than one measurable lesion according to RECIST v1.1; 4. Pathologically confirmed malignant pleural effusion; 5. No prior antitumor therapy. 6. Tumor tissue samples or blood samples are confirmed to be EGFR mutations (including 19del or 21L858R); 6. Estimated lifetime is greater than 3 months. 7. ECOG PS 0-3; 8. Life expectancy >3 months; 9. Patients have adequate baseline organ and marrow function: (1) Hematological parameters: absolute neutrophil count >= 1.75 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 9.0 g/dL (can be maintained by transfusion); (2) Liver function criteria: total bilirubin = 66ml/min. 10. Women of childbearing age must have a negative urine pregnancy test within 3 days prior to initial treatment. If a negative urine pregnancy test result cannot be confirmed, a blood pregnancy test will be requested. Females not of childbearing age were defined as being at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects (male or female) will be required to use contraception with an annual failure rate of less than 1% throughout the treatment period up to 120 days after end-of-treatment study drug administration (or 180 days after end-of-chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Subjects suffer from other malignant tumors in the past 5 years, excluding cured basal cell carcinoma, cervical carcinoma in situ, and surgically treated localized prostate cancer or surgically removed ductal carcinoma in situ. 2. Subjects who have received previous chemotherapy or systemic anti-tumor therapy (including targeted therapy, immunotherapy, etc.) within 28 days . 3.Have not recovered from any intervention-induced toxicity and/or complications (i.e., = Grade 1 or at baseline, excluding malaise or alopecia) prior to initiation of treatment; 3. Any unstable systemic disease (including active infection, poorly controlled high blood pressure, unstable angina, congestive heart failure, liver, kidney or metabolic disease). 4. Presence of symptomatic CNS metastases and/or carcinomatous meningitis. For subjects with previously treated brain metastases, they may participate in the trial if they have stable disease (no evidence of imaging progression for at least 4 weeks prior to the first dose of the trial treatment), repeat imaging confirms that there is no evidence of new brain metastases or increase in size of the original brain metastatic lesion, and they do not require steroid therapy for at least 14 days prior to the first dose of the trial treatment. This exception does not include carcinomatous meningitis, which should be excluded regardless of whether it is clinically stable; 5. Pregnant or breastfeeding women; 6.History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 7.History of human immunodeficiency virus (HIV) infection or confirmed severe infection with a positive immunization test result, presence of active disease, or poor clinical control 8.Acute or chronic active hepatitis B or hepatitis C infection with hepatitis B virus (HBV) DNA > 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA > 103 copies/ml; and both hepatitis B surface antigen (HbsAg) and anti-HCV antibodies positive. Below the above criteria after nucleotide-based antiviral therapy, they can be enrolled; 9. Clinically significant or uncontrolled cardiac disease, including unstable angina pectoris, acute myocardial infarction within 6 months prior to the first dose, New York Heart Association class III/IV congestive heart failure, and uncontrolled arrhythmia (pacemakers or subjects with atrial fibrillation with good rate control are permitted); 10.Presence of ECG changes or history that the investigator considers clinically significant; screening QTcF intervals >480 ms, and for subjects with intraventricular conduction block (QRS intervals >120 ms), JTc intervals may be used in lieu of QTc intervals with sponsor approval (if JTc is used in lieu of QTc, JTc must be =340 ms); 11.Uncontrollable hypertension with systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg after optimal medical therapy, hypertensive crisis or history of hypertensive encephalopathy; 12. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh class B or more severe cirrhosis. 13.Major surgical procedure (open cranial, open thoracic, or open abdominal surgery) within 4 weeks prior to the first dose of study treatment or anticipation of the need for major surgery during study treatment; 14. Pregnant or breastfeeding females, or subjects who are expected to conceive or give birth during the study period from the Screening Visit to the completion of the Safety Follow-Up Visit (up to 90 days after the final dose for m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Objective response rate of pleural effusion ; | — |
Secondary
| Measure | Time frame |
|---|---|
| progress free survival;Disease control rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactChen Cheng
The First Affiliated Hospital of Soochow University
Outcome results
None listed