lung cancer
Conditions
Interventions
experimental group 1:Icotinib 125 mg three times a day (TID)+ drug holidays
experimental group 2:Icotinib 125 mg three times a day (TID)+ conventional treatment
Control group:none
Sponsors
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed stage IA1-IB NSCLC; underwent R0 resection, clinically confirmed as stage IA1-I by histopathology, and EGFR 21 L858R, 19Del sensitive mutations confirmed by tissue samples or blood by each center, and positive for minimal residual disease (MRD) within 3-28 days post-surgery; 2) With any >=1 high-risk factors; high-risk factors include: pleural invasion, airway dissemination, vascular invasion, poorly differentiated, pathological micropapillary component >=5%, complex gland component >=5%, etc.; 3) Voluntarily accept MRD screening and voluntarily accept adjuvant therapy with oral Icotinib; 4) Have not received any EGFR-TKI treatment, and previously allowed to have received up to one line of chemotherapy; 5) ECOG performance status (PS) score of 0-1; 6) Age: 18-75 years; Gender: both males and females, with an effort to balance; life expectancy of at least 12 months; 7) Have certain organ system functions, defined as follows, at the discretion of the investigator: a. Absolute neutrophil count (ANC) >=1.5 x 10^9/L b. Platelets >=80 x 10^9/L; c. Hemoglobin >=9 g/dL (>=90g/L) Note, transfusion is allowed to achieve the required hemoglobin level; d. Total bilirubin = 1.5 × ULN, if the creatinine clearance value calculated by the Cockcroft-Gault method is >= 50 mL/min (0.83 mL/s), the patient is still eligible for inclusion; 8) Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, with a negative result, and be willing to use a medically recognized highly effective contraceptive method (such as: intrauterine device, birth control pills, or condoms) during the study period and for 3 months after the last administration of the study medication; for male subjects with partners of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and for 3 months after the last administration of the study medication; 9) Voluntarily and capable of complying with the procedures of the trial and follow-up. 10) Able to understand the nature of the trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) No EGFR 21 L858R, 19Del mutations or MRD negative; presence of EGFR combined with RB1 mutations; 2) Patients who do not meet the staging criteria or have previously received any EGFR-TKI treatment; 3) Any other treatment methods existed before surgery, and informed consent was not signed; 4) Patients diagnosed with cancer within 2 years; have received systemic anti-tumor treatment, including chemotherapy, radiotherapy, or targeted therapy, before enrollment in this study; 5) Patient's organ system conditions: a. History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; interstitial lung disease found on baseline CT scan; evidence of severe or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, cardiac, hepatic, or renal diseases) as judged by the investigator; any unstable systemic diseases (including active infections, grade III hypertension, unstable angina, congestive heart failure, hepatic, renal, or metabolic diseases); b. Patients who cannot receive oral medication, require intravenous high-calorie nutrition, have previously undergone surgery affecting absorption, or have active peptic ulcers; c. Any significant ocular abnormalities, especially severe dry eye syndrome, dry keratoconjunctivitis, severe exposure keratitis, or other diseases that may increase epithelial damage; history of definite neurological or psychiatric disorders, including epilepsy or dementia; 6) Patients known to be allergic to any component of Icotinib or similar drugs; 7) Pregnant or lactating women; 8) Other situations deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 3-year disease-free survival rate of the overall study population; | — |
Secondary
| Measure | Time frame |
|---|---|
| The 3-year disease-free survival rate of continuous positive MRD and negative MRD;5-year disease-free survival rate;5-year overall survival rate; | — |
Countries
China
Contacts
Public ContactShaojin ZHU
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
Outcome results
None listed