non-small cell lung cancer (NSCLC)
Conditions
Interventions
Experimental group:Aumolertinib after adjuvant chemotherapy/radiotherapy
Control group:Adjuvant chemotherapy/radiotherapy
Sponsors
The People's Hospital of Guizhou Province
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Willing to participate in this study, able to understand and sign the informed consent; 2. Aged >=18 years; 3. ECOG PS physical status score =3.0 months; 9. One week before randomization, the bone marrow, liver and kidney functions of the patients met the following criteria: (1) Hemoglobin >=100 g/L, neutrophils >=1.5x10^9/L and platelets >=100x10^9/L; (2) Total bilirubin =60 ml/min, urea nitrogen 1+, the 24-hour total urinary protein must be < 500mg; 10. Patients of childbearing age consented to a reliable method of contraception before entry into the study and during the study until 90 days after discontinuation, and women of childbearing age had to have a negative urinary pregnancy test within 7 days before starting treatment and were not breast-feeding.
Exclusion criteria
Exclusion criteria: 1. There are other driver genes such as ALK and ROS1 mutants; 2. Allergic to amertinib and its components; 3. Patients with underlying diseases that cannot tolerate chemoradiotherapy; 4. Uncontrolled major diseases such as AIDS, neuropathy/mental illness such as Alzheimer's disease; 5. Received any other investigational drugs within 4 weeks before enrollment; 6. A history of immunodeficiency, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7. Concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the patient or interfere with the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival at 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median disease-free survival;Median overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZhang Yu
The People's Hospital of Guizhou Province
Outcome results
None listed