Lung Cancer
Conditions
Interventions
Treatment group:Aumolertinib
Sponsors
Tianjin medical university cancer institute&hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) voluntarily participate and sign the informed consent form in writing. (2) 18-70 years old, regardless of sex. (3) patients with stage I (AJCC (8th edition) lung cancer staging) NSCLC confirmed by pathology. (4) R0 resection. (5) the patient should have one or more residual ground glass nodules (< 3cm), whose malignant degree is confirmed by radiologists and chest surgeons. (6) the mutation of EGFR sensitive gene was positive. (7) the functions of major organs such as blood, heart, lungs, liver and kidney are basically normal: A) liver function: serum bilirubin (TBIL) = 1.5x normal upper limit (ULN); alkaline phosphatase (ALP) = 2.5x ULN; glutamic oxaloacetic transaminase (AST) and glutamic pyruvic transaminase (ALT) = 2.5x ULN. B) Renal function: serum creatinine = 1.2ULN. (8) the ECOG score of physical condition score is 0: 1. (9) Men or women of childbearing age are willing to use contraception in the trial
Exclusion criteria
Exclusion criteria: (1) participated in other clinical trials within one month before the trial. (2) the patient had previously received TKI small molecule targeted anti-tumor therapy or EGFR monoclonal antibody anti-tumor therapy. (3) the residual GGN after operation is benign or metastatic. (5) other serious medical diseases or serious uncontrollable infections; intractable dysentery or intestinal spasm, intestinal obstruction, history of cardiovascular disease: Uncontrollable hypertension, unstable angina pectoris, history of myocardial infarction or symptomatic congestive heart failure or uncontrollable arrhythmia in the past 12 months. CTC3.0 II degree arrhythmia, second degree myocardial ischemia, second degree troponin T abnormality, second degree hypertension, left ventricular ejection fraction<50%, etc. (6) undesirable drug addiction such as drug addiction, long-term alcohol addiction, active hepatitis B, hepatitis C or HIV infection. (7) except for patients with a history of active malignant tumors other than small cell lung cancer, non-melanoma skin cancer, cervical cancer in situ and cured early prostate cancer. (8) patients who have allergies and are known or suspected to be allergic to any research drug. (9) patients with poor compliance. (10) patients during pregnancy and lactation. (11) the researchers do not think it is appropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate(ORR); | — |
Countries
CHINA
Contacts
Public ContactChong biao Huang
Tianjin medical university cancer institute&hospital
Outcome results
None listed