Non-small cell lung cancer
Conditions
Interventions
Experimental group:Treatment of Atezolizumab
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. Gender: both men and women, as balanced as possible; 3. The patient has a pathologically confirmed diagnosis of non-small cell lung cancer, and the pathological type is not the adenocarcinoma with positive driver gene (EGFR/ALK). PD-L1 expression was positive in tumor tissues (>=1%); 4. According to the eighth edition of the AJCC staging system, the clinical stage before initial treatment is stage II-IIIB (if neoadjuvant therapy has been received), or the postoperative pathological stage is stage II-IIIB; 5. The patient has undergone radical surgery and has reached R0 resection; 6. The patient is willing and financially able to receive postoperative adjuvant treatment with atezolizumab according to the research plan and will be re-examined as scheduled; 7. ECOG behavioral status score of 0~1, expected survival time > 1 year; 8. The level of organ function must meet the following requirements: a. Bone marrow: absolute neutrophil count (ANC) >=1.5× 10^9/L, platelet >=100 × 10^9/L, hemoglobin >=9 g/dL; b. Good coagulation: defined as international normalized ratio (INR) or prothrombin time (PT) = 60 ml/min; 9. Females of childbearing potential must have a pregnancy test within 7 days before starting treatment with a negative result, and use contraception during and within 3 months after the end of treatment; Males of childbearing age: use contraception during surgical sterilization or treatment and for 3 months after the end of treatment; 10. Understand and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. The pathological type of the patient is adenocarcinoma with EGFR/ALK mutation; 2. The patient has been diagnosed with other malignant tumors in the past; 3. Prior interstitial lung disease, drug-induced interstitial disease, or any active interstitial lung disease with clinical evidence; Idiopathic pulmonary fibrosis on CT scan at baseline; 4. Evidence of severe or uncontrollable systemic disease (such as unstable or uncompensatory respiratory, cardiac, hepatic or renal disease) as judged by the investigator; 5. Any unstable systemic disease (including active infection, grade III hypertension, unstable angina, congestive heart failure, hepatorenal or metabolic disease); 6. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia; 7. Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection; 8. Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or some other infectious diseases deemed inappropriate for enrollment; 9. Those who are known to be severely allergic to atezolizumab and/or any of its excipients; 10. Pregnant or lactating women; 11. Other situations that the investigator thinks cannot be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Disease Free Survival Rate;2-year Overall Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event Incidence;5-year overall survival rate;PD-L1 Expression Level and Its Correlation with Efficacy; | — |
Countries
China
Contacts
Public ContactJian Zeng
Zhejiang Cancer Hospital
Outcome results
None listed