EGFR Mutation-Positive NSCLC Patients with Recurrence After Adjuvant Therapy with First-Generation EGFR-TKIs Following Radical Resection
Conditions
Interventions
Recurrence group after post-operative adjuvant therapy:Furmonertinib
Sponsors
The Forthe Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old. 2.Patients who have undergone radical surgical resection and have post-operative pathology confirming EGFR mutation-positive NSCLC (EGFR mutation-positive includes classical mutations: exon 19 deletions (Del19) and exon 21 L858R mutations; non-classical mutations: G719X, L861Q, S768I). 3.Post-operative treatment with at least 2 years of first-generation EGFR-TKI adjuvant therapy. 4.ECOG performance status of 0-2. 5.Expected survival time > 3 months. 6.Organ function: The participant must meet the following laboratory criteria: (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L without the use of granulocyte colony-stimulating factors in the past 14 days. (2) Platelet count >=100 × 10^9/L without blood transfusion in the past 14 days. (3) Hemoglobin > 9 g/dL without blood transfusion or erythropoiesis-stimulating agents in the past 14 days. (4) Total bilirubin = 50 ml/min. (7) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN. If the participant is on anticoagulant therapy, PT should be within the range specified by the anticoagulant medication. 7.For women of childbearing potential, a urine or serum pregnancy test should be performed within 3 days prior to the first dose of the study drug (Day 1 of Cycle 1) with a negative result. If the urine pregnancy test cannot confirm a negative result, a blood pregnancy test is required. Women of non-childbearing potential are defined as postmenopausal for at least 1 year or have undergone surgical sterilization or hysterectomy. 8.All participants (both male and female) of childbearing potential must use contraception with a failure rate of less than 1% throughout the treatment period and for 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy)
Exclusion criteria
Exclusion criteria: 1.Post-operative EGFR-TKI adjuvant therapy for less than 2 years without recurrence. 2.After recurrence as determined by the investigator, the patient received radiotherapy, chemotherapy, immunotherapy, or other targeted therapies before enrollment. 3.Use of traditional Chinese medicine or traditional Chinese medicine preparations with anti-tumor indications, or with tumor adjuvant therapy effects, within 14 days before the first dose, as well as other unmentioned drugs with anti-tumor activity. 4.Any clinical evidence suggesting severe or uncontrolled systemic diseases, such as uncontrolled hypertension, uncontrolled diabetes, coronary artery stenosis, aortic dissection, aortic aneurysm, active bleeding tendencies, hepatitis B virus infection (HBV-DNA = 1000 cps/ml), hepatitis C virus infection, human immunodeficiency virus (HIV) infection, etc., that the investigator deems unsuitable for participation or that may affect the patient's adherence to the study protocol. Left ventricular ejection fraction (LVEF) < 50%. 5.History of other malignancies or current concurrent malignancies (excluding malignancies that have undergone radical treatment and have not recurred for 5 years, such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and papillary thyroid carcinoma). 6.Patients deemed unsuitable for participation in the study for other reasons by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Disease Control Rate;Safety outcomes; | — |
Countries
China
Contacts
Public ContactQingyi Liu
The Forthe Hospital of Hebei Medical University
Outcome results
None listed