lung cancer
Conditions
Interventions
experimental group:Icotinib 125mg, TID, po, continuously used for 2 years
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Had completely resected pathological confirmed stage IA2-IB, invasive, non-squamous NSCLC,based on TNM 8 classification; 2.Consolidation-to-tumor ratio (CTR) =75%; 3.EGFR activating mutation in exon 19 or 21; 4.ctDNA-based MRD was confirmed to be positive by laboratory at postoperative 30±7 day ; 5.Males or females, Aged 18-75 years; 6.ECOG performance status of 0-2; 7. The level of organ function must meet the following requirements: Bone marrow: Absolute neutrophil count (ANC) = 1.5 × 10 ^ 9/L, platelet = 90 × 10 ^ 9/L, hemoglobin = 9 g/dl; Good coagulation function: defined as international standardized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; Liver: total bilirubin = 1.5 times the upper limit of normal value, aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 times the upper limit of normal value; Kidney: Serum creatinine = 1.25 times the upper limit of normal value or creatinine clearance rate (calculated using Cockcroft Gault formula) = 60 ml/min; 8. Women of childbearing age must undergo a pregnancy test with a negative result within 7 days before starting treatment, and take contraceptive measures during the treatment period and within 3 months after the end of the treatment; Male of childbearing age: Take contraceptive measures during surgical sterilization or treatment and within 3 months after the end; 9. Understand and voluntarily sign a written informed consent form
Exclusion criteria
Exclusion criteria: 1.Other cancers were diagnosed or treated within 5 years of randomization in this study (except for patients with resected skin basal-cell carcinoma or other carcinoma in situ) ; 2.Previous systemic anti-tumor therapy,including chemotherapy,radiotherapy and targeted therapy(including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc); 3. Patients with total right lung resection; 4.Patients with exon 20 T790M mutation and other rare mutations or double mutations; 5.Minimally Invasive Adenocarcinoma 6.Consolidation-to-tumor ratio (CTR) 1.5 times the upper limit of normal value; Serum creatinine>1.25 times the normal standard value; Patient suffering from any other diseases, neurological or metabolic disorders, evidence of physical examination or laboratory examination results reasonably suspects that there is a disease, or there is a counter indication for the use of related drugs, or the subject may be at high risk of treatment related complications. 9.Allergic to study drug or pharmaceutical excipients 10.During pregnancy or breastfeeding 11.Other circumstances may not be suitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival;2/5-year disease free survival rates;5-year overall survival rates;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactQinghua Zhou
Lung Cancer Center, West China Hospital, Sichuan University
Outcome results
None listed