Lung adenocarcinoma
Conditions
Interventions
intervention group:Assisted use of Ensatinib medication for one year
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Provide informed consent prior to any specific research procedure; 2) The age range is between 18 and 75 years old (including 18 and 75 years old), and both males and females are eligible; 3) Pathological confirmed stage IA lung adenocarcinoma patients (UICC/AJCC 8th edition staging); 4) At least one of the following high-risk factors exists: a. Pathological confirmation of vascular invasion; b. Pathological confirmation shows that the tumor has a pathological type of solid growth, micropapillary growth, or complex glass growth, and the proportion is greater than 20%; c. Combined airway dissemination. 5) Patients confirmed as ALK positive in written reports (confirmed by FISH or Ventana IHC or RT-PCR or NGS testing); 6) Has not received any anti-tumor treatment in the past; 7) ECOG's physical condition is 0-1. 8) The subjects have good hematopoietic and organ function, and the laboratory test values meet the following requirements: a. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count (PLT) >= 100 × 10^9/L, hemoglobin (HB) >= 9g/dL; (Note: No blood transfusion or use of component blood or hematopoietic stimulating factors within 14 days prior to the first administration); b. Serum total bilirubin (TBIL) = 50 mL/min; 9) Female subjects with fertility need to have a negative serum pregnancy test during screening. The definition of infertility is as follows (for reasons other than medication): a. Age >= 45 years and menopausal period exceeding 1 year; b. Age= 2 years, and have not undergone hysterectomy or oophorectomy, with follicle stimulating hormone (FSH) levels within the postmenopausal range during the screening period; c. Its status is after hysterectomy, oophorectomy, or tubal ligation. 10) Women with the possibility of pregnancy, as well as male participants whose partners are women of childbearing age, must use highly effective contraceptive methods throughout the entire study process (such as oral contraceptives, intrauterine devices, abstinence control, or barrier contraception combined with spermicides), and continue contraception for 3 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1) Any systemic anti-cancer therapy, including cytotoxic drug therapy, targeted drug therapy (including tyrosine kinase inhibitors or monoclonal antibodies), or experimental therapy, has been performed for NSCLC before or after surgery; 2) There are unresectable or metastatic diseases, pathological reports showing positive surgical margins under the microscope or extranodal invasion, or residual lesions during surgery, or suspicious lesions determined by imaging after surgery; 3) Patients with mixed components of small cell lung cancer; 4) The patient is pregnant or breastfeeding; 5) Currently receiving (or unable to discontinue use before receiving the first dose of study treatment) drugs or herbal supplements known to be potent inducers/inhibitors of CYP3A4, P-glycoprotein inhibitors (at least 3 weeks ago). All subjects must try to avoid the concomitant use or ingestion of any drugs, herbal supplements, and/or foods known to induce/inhibit CYP3A4 and inhibit P-glycoprotein. 6) Any unstable systemic disease (including active infection, unstable angina pectoris, angina pectoris that has started to occur in the past 3 months, congestive heart failure, myocardial infarction that occurred within the last 6 months before enrollment, severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases); 7) Local radiotherapy has been performed for NSCLC; 8) History of hypersensitivity reactions to active or inactive excipients of the investigational drug (Ensatinib) or drugs with similar chemical structures or categories to the investigational drug (Ensatinib), as well as uncontrollable nausea and vomiting, chronic gastrointestinal diseases, inability to swallow formulated drugs, or exposure to large intestinal resection surgeries that would hinder sufficient absorption of the investigational drug (Ensatinib). 9) History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of active interstitial lung disease; 10) Having a clear history of neurological or mental disorders, including epilepsy or dementia; 11) Other researchers believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival period;Overall survival;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactHu Liao
West China Hospital of Sichuan University
Outcome results
None listed