Non-small cell lung cancer
Conditions
Interventions
Experimental Group:Icotinib or Ensartinib
Sponsors
Beijing chest hospital capital medical university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18-75 years old, with a balance as much as possible 2) Patients with non-small cell lung adenocarcinoma confirmed as stage IA (AJCC 9th Edition staging) by postoperative histopathology And there is at least one of the following high-risk factors (poorly differentiated tumor [histological subtype of any subtype and high-grade components such as micropapillary type, solid type, complex glands, sieve-like structure, etc. >= 20%], lymphovascular infiltration (LVI), spread through the air gap (STAS), vascular tumor thrombus, unknown lymph node status (pNx), segmentectomy, sublobectomy, wedge resection) 3) Postoperative tissue genetic testing confirmed positive EGFR-sensitive mutations or ALK fusion mutations 4) Accept the research plan and undergo follow-up 5) ECOG status score ranges from 0 to 1, and the expected survival time is over 1 year 6) Good organ function 6.1) Sufficient blood function: hemoglobin >= 90g/L, absolute neutrophil count (ANC) >= 1.5× 10^9/L, platelet count >= 100× 10^9/L 6.2) Good renal function: serum creatinine = 50ml /min. It is only necessary to confirm the clearance rate when serum creatinine is greater than 1.5 times ULN 6.3) Normal liver function : ALT and AST <= 2.5× ULN. If one has Gilbert syndrome (non-conjugated hyperbilirubinemia), the total serum bilirubin should be <= 3× ULN 7) Voluntarily sign the informed consent form
Exclusion criteria
Exclusion criteria: 1) There were any other systemic tumor treatment options available before enrollment, including radiotherapy or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.) 2) The patient has been diagnosed with other malignant diseases other than non-small cell lung cancer within 2 years (excluding radical cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radical resection of carcinoma in situ); 3) There is objective clinical evidence (pathology or imaging) confirming tumor recurrence before the initiation of adjuvant therapy; 4) Patients with exon 20 T790M mutation and other rare mutations, as well as double mutations; 5) The histopathological results show squamous cell carcinoma, small cell carcinoma, large cell neuroendocrine carcinoma or sarcomatoid carcinoma, etc. 6) Patients who are known to be allergic to icotinib or compounds with similar structures or any excipient components, or who may experience hypersensitivity reactions; 7) Previous history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence; At baseline, CT scans revealed the presence of idiopathic pulmonary fibrosis. 8) Patients with subsided or chronic HBV infection who meet the following conditions: 8.1) HBsAg negative, hepatitis B core antibody [anti-HBC IgG] positive or 8.2) HBsAg positive, HBeAg negative, but transaminase level lower than ULN, HBV DNA level less than 2000 IU/mL(i.e., in an inactive carrier state) for more than 6 months. 9) Any unstable systemic diseases (including active infections, grade III hypertension, unstable angina pectoris, congestive heart failure, liver, kidney or metabolic diseases); 10) There is a clear history of neurological or mental disorders in the past, including epilepsy or dementia; 11) Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection, etc. 12) Pregnant or lactating women; 13) During the trial period, sexually active men and women of childbearing age were unwilling to use effective contraceptive methods. For women within 6 weeks and men within 4 months after discontinuation of icotinib treatment. 14) Situations where other researchers consider it unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year DFS rate;Disease-Free Survival ;2/3 year OS rate; | — |
Countries
China
Contacts
Public ContactZhidong Liu/Tongmei Zhang
Beijing chest hospital capital medical university
Outcome results
None listed