| Eligibility |
Inclusion Criteria:
1. The subjects voluntarily joined the study and were able to sign the informed consent
with good compliance;
2. Age 18-80 years old (when signing the informed consent form);
3. Patients with histologically or cytologically proven locally advanced (stage IIB/IIC),
metastatic, or recurrent (stage IV) NSCLC who are inoperable and unable to receive
radical concurrent chemoratherapy, according to the International Association for the
Study of Lung Cancer and the American Joint Committee on Cancer Classification, 8th
Edition TNM Classification of Lung cancer;
4. Have not received systemic intravenous anti-tumor therapy before, and the driver gene
is negative;
5. PD-L1 expression < 50%;
6. According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there
is at least one radiographically measurable lesion; That is, in CT or MRI detection,
the longest diameter of a single lesion was =10mm, or the pathological enlargement of
a single lymph node was =15mm.
7. The physical status score of Eastern Tumor Collaboration Group (ECOG) was 0-1;
8. Expected survival > 3 months;
9. Have adequate organ and bone marrow function, laboratory examination within 7 days
prior to enrollment meets the following requirements (no blood components, cell growth
factors, albumin or other corrective drugs are allowed within 14 days prior to
obtaining laboratory examination), as follows: 1) Blood routine: absolute neutrophil
count (ANC) =1.5×109/L, platelet (PLT) =75×109/L, hemoglobin (HGB) =90 g/L (no blood
transfusion or erythropoietin dependence within 14 days); 2) Liver function: serum
total bilirubin (TBIL) =2 times the upper limit of normal (ULN); Alanine
aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 5x ULN, serum albumin
=28 g/L; alkaline phosphatase (ALP) =5×ULN; 3) Renal function: serum creatinine (Cr)
=1.5×ULN, or creatinine clearance =50 mL/min (using the standard Cockcroft-Gault
formula) : Urine routine results showed urinary protein < 2+; For patients with urine
protein =2+ at baseline, 24-hour urine collection and 24-hour urine protein
quantification < 1g should be performed. 4) Coagulation function: International
standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; If the subject is
receiving anticoagulant therapy, as long as the INR is within the intended range of
anticoagulant drug use.
10. For female subjects of reproductive age, a urine or serum pregnancy test should be
performed and the result is negative 3 days prior to receiving the initial study drug
administration;
11. Subjects and their sexual partners are required to use a medically approved
contraceptive method (such as an IUD, contraceptive pill, or condom) during the study
treatment period and for 6 months after the end of the study treatment period.
Exclusion Criteria:
1. Currently participating in an interventional clinical study or receiving another
investigational drug or investigational device within 4 weeks prior to initial dosing;
2. Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory
drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first
administration, or received major surgical treatment within 3 weeks before the first
administration;
3. Class III - IV congestive heart failure (New York Heart Association classification),
poorly controlled and clinically significant arrhythmias;
4. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable
angina pectoris, cerebrovascular accident or transient ischemic attack, occurred
within 6 months before treatment;
5. Known allergic reaction to the drug in this study;
6. Patients requiring long-term systemic use of corticosteroids. Patients with COPD or
asthma requiring intermittent use of bronchodilators, inhaled corticosteroids, or
local corticosteroids could be enrolled.
7. Symptomatic central nervous metastases. Patients with asymptomatic BMS or BMS whose
symptoms are stable after treatment are eligible to participate in this study if they
meet all of the following criteria: measurable lesions outside the central nervous
system; No midbrain, pontine, cerebellum, meninges, medulla oblongata or spinal cord
metastasis; Maintain clinical stability for at least 2 weeks; Stop hormone therapy 3
days before the first dose of the study drug;
8. There is an active infection requiring treatment or systemic anti-infective drugs have
been used in the week prior to the first dosing;
9. Has not fully recovered from toxicity and/or complications caused by any intervention
before starting treatment (i.e., = grade 1 or baseline, excluding weakness or hair
loss);
10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody
positive);
11. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number
detected greater than the upper limit of normal value in the laboratory of the study
center);
Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
1. HBV viral load <1000 copies /ml (200 IU/ml) before initial administration, subjects
should receive anti-HBV therapy throughout the study chemotherapy drug treatment to
avoid viral reactivation;
2. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-),
prophylactic anti-HBV therapy is not required, but close monitoring of viral
reactivation is required.
12. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower
limit of detection); 13. Received live vaccine within 30 days prior to the first dose
(cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is
permitted for 30 days prior to initial administration; However, live attenuated influenza
vaccines administered intranasally are not permitted.
14. Pregnant or lactating women; 15. Medical history or evidence of disease that may
interfere with test results, prevent participants from fully participating in the study,
abnormal treatment or laboratory test values, or other conditions that the investigator
considers unsuitable for enrollment The Investigator considers other potential risks
unsuitable for participation in the study.
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