TMN was stage I and ALK-positive NSCLC with high risk factors
Conditions
Interventions
Experimental group:All patients were given ensartinib 200 mg orally once a day orally for 2 years or discontinued due to disease recurrence or intolerable toxicity.
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old; 2. ECOG score 0-1; 3. Postoperative histopathology confirmed that R0 resection TNM stage I lung adenocarcinoma; 4. Confirmed positive for ALK fusion by FISH, IHC or NGS; 5. Not receiving any systemic treatment after surgery; 6. At least one high-risk recurrence factor: poorly differentiated tumors (including micropapillary adenocarcinoma, neuroendocrine tumors, etc., but excluding well-differentiated neuroendocrine tumors), vascular invasion, wedge resection, visceral pleural involvement, unknown lymph node status, and intra-airspace dissemination; 7. Able to start adjuvant ensartinib therapy within 4-8 weeks after surgery; 8. Hematology, biochemistry and organ function meet the requirements: hemoglobin >=100 g/L; Absolute neutrophil count>=1.5×10^9/L; Platelet count>=100×10^9/L; Total bilirubin =60mL/min; 9. Women of childbearing age must have a urine pregnancy test within 7 days before starting treatment and the result is negative; 10. Obtain informed consent signed by the patient or his/her legal representative; 11. Male and female patients of childbearing age agree to use reliable methods of contraception before entering the trial, during the study and until 8 weeks after discontinuation of the drug.
Exclusion criteria
Exclusion criteria: 1.Had received any systemic therapy for NSCLC; 2.Local radiotherapy had been performed for NSCLC; 3.Inability to take oral medications; 4.Known allergy to Ensartinib or any of the ingredients in this product; 5.Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any clinically evidence of active interstitial lung disease; Idiopathic pulmonary fibrosis was noted on a CT scan at baseline; 6.Any unstable systemic illness, including active infection, uncontrolled hypertension, unstable angina, angina with onset within the last 3 months, congestive heart failure (>= New York Heart Association [NYHA] class II), myocardial infarction (within 6 months before enrollment), severe arrhythmias requiring medical therapy, or hepatic, renal, or metabolic disease. 7.Pregnant or lactating women; 8.There was a clear previous history of neurological or psychiatric disorders, including epilepsy or dementia; 9.Other conditions considered by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5 year OS rate;DFS;Quality of life; | — |
Countries
China
Contacts
Public ContactSu Chunxia
Shanghai Pulmonary Hospital
Outcome results
None listed