lung cancer
Conditions
Interventions
Gold Standard:Clinical outcome
Index test:bTMB
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily participated in the study, signed informed consent, and had good compliance; 2. In patients with pathologically confirmed, untreated and advanced NSCLC, the driving gene was negative; 3. At least one measurable lesion was confirmed according to RECIST 1.1 standard; 4. Age: 18-75 years old; 5. ECoG PS score 0 ~ 1; 6. The expected survival time was more than 3 months; 7. Within 7 days before treatment, the main organ functions met the following criteria: Blood routine examination standard (without blood transfusion within 14 days); Hemoglobin (HB) >= 90g/L; The absolute value of neutrophil (ANC) >= 1.5x10^9/L; Platelet (PLT) >= 80x10^9/L; Biochemical examination should meet the following standards: Total bilirubin (TBIL) = 60 ml/min; Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >=the lower limit of normal value (50%). 8. Women of childbearing age should agree that contraceptive measures (such as intrauterine device, contraceptive or condom) must be used during the study period and within 6 months after the end of the study; serum or urine pregnancy test negative within 7 days before study enrollment, and must be non lactating patients; men should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1) Patients who have received chemotherapy, targeted therapy, immunotherapy or antiangiogenesis therapy; 2) Severe allergic reactions (>= grade 3) to the active ingredients and or any excipients of the drugs used in this study were known; 3) Other malignancies occurred or were present within 5 years, except for cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 4) Those who have received local radiotherapy in the past can be enrolled if the following conditions are met: the end of radiotherapy is more than 4 weeks from the beginning of study treatment (brain radiotherapy is more than 2 weeks); and the target lesion selected in this study is not in the radiotherapy area; or the target lesion is located in the radiotherapy area, but the progress has been confirmed. 5) Subjects with cancerous meningitis; 6) Subjects with known central nervous system metastasis and / or spinal cord compression; unless asymptomatic or treated and stable, no imaging evidence of new brain metastases or enlargement of brain metastases was found at least 2 weeks after brain metastases treatment, and steroids or anticonvulsant drugs were stopped for at least 14 days before the start of study treatment. 7) Uncontrolled pleural effusion, pericardial effusion and peritoneal effusion requiring repeated drainage; 8) Those who have a history of abuse of psychotropic drugs and can not quit or have mental disorders; 9) Participated in other clinical trials within four weeks; 10) According to the judgment of the researchers, there are accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study. 11) The subjects and their sexual partners could not or refused to take effective contraceptive measures during the clinical trial (see below for details); 12) Pregnant and lactating women; 13) Other researchers considered that it was not suitable to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| btmb; | — |
Countries
China
Contacts
Public ContactWei Nie
Shanghai Chest Hospital, Shanghai Jiaotong University
Outcome results
None listed