| Eligibility |
Inclusion Criteria:
1. Age =18 years old, both male and female.
2. Histopathology or cytology confirmed advanced Stage IIIB-IV non-small cell lung
cancer.
3. No prior systemic treatment to advanced NSCLC . Subjects who have received prior
neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for
non-metastatic disease must have experienced a treatment free interval of at least 12
months from randomization since the last chemotherapy cycle.
4. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria.
5. Eastern Cooperative Oncology Group (ECOG) performance status of = 1.
6. Have a life expectancy of at least 3 months.
7. All baseline laboratory requirements will be assessed.
8. Can swallow pills normally.
9. Remission of all acute toxic reactions to previous antitumor therapy to grade 0-1 or
to the level specified in the exclusion criteria.
10. Female Subjects of childbearing potential must have a negative serum pregnancy test
within 7 days before the first dose, are not breastfeeding, and must be willing to use
very efficient barrier methods of contraception for the course of the study through
180 days after the last dose of study treatment. Male subjects whose partners are
fertile women should be surgically sterilized or agree to use effective contraception
during the trial period and 90 days after the last administration of the study drug,
and sperm donation is not allowed during the study period.
11. Subjects has voluntarily agreed to participate by giving written informed consent.
Willing and able to follow planned visits, research treatments, laboratory tests and
other test procedures.
Exclusion Criteria:
1. Patients with non-small cell lung cancer diagnosed with other histopathological types,
including patients with NSCLC containing small cell lung cancer components.
2. Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or
anaplastic lymphoma kinase (ALK) translocation.
3. Patients who have previously received PD-(L)1 or CTLA-4 treatment.
4. Subjects with active CNS metastases are excluded.
5. Subjects with active, known or suspected autoimmune disease. Participants who are in a
stable state and do not require systemic immunosuppressive therapy are permitted to
enroll.
6. Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV)
infection.
7. Have the following poorly controlled infectious diseases: active viral hepatitis B or
C; Have active TB or are currently receiving anti-TB treatment.
8. There is past or present objective evidence of idiopathic pulmonary fibrosis,
interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (such as
bronchitis, vasculitis obliterans), drug-induced pneumonia, active pneumonia on CT
examination, or severe impairment of lung function.
9. Subjects with clinically significant cardiovascular and cerebrovascular diseases.
10. Active infection (CTCAE> Grade 2).
11. Diagnosed with immune deficiency or receiving systemic glucocorticoid therapy or any
other form of immunosuppressive therapy not directly related to tumor treatment within
7 days prior to study enrollment; Physiological doses of glucocorticoids are
permitted.
12. Other malignancies developed within 5 years prior to admission, excluding adequately
treatable cervical carcinoma in situ, basal cell or squamous cell skin cancer, local
prostate cancer after radical surgery, and ductal carcinoma in situ after radical
surgery.
13. Subjects received major surgery within 4 weeks of the first dose of study treatment or
planned during the study period.
14. Subjects had administration of a live, attenuated vaccine within 4 weeks of the first
dose of study treatment or anticipation that such a live attenuated vaccine will be
required during the study.
15. Subjects who are alcohol dependent or have a history of drug or substance abuse within
the last 1 year.
16. Subjects with a known neurological or mental disorder, such as epilepsy, dementia, or
the presence of a peripheral nervous system disorder.
17. Subjects had or plan to have allogeneic bone marrow transplantation or solid organ
transplant.
18. Pregnant or lactating female; The fertile subject is unwilling or unable to take
effective contraceptive measures.
19. Known allergy to the investigational drug or excipient.
20. Received any other investigational medicine treatment or participated in another
interventional clinical study within 4 weeks prior to signing the ICF.
21. Abnormal coagulation function .Thrombosis or thromboembolic event within 6 months
prior to the start of study treatment.
22. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the subject's
participation for the full duration of the study, or is not in the best interest of
the subject to participate, in the opinion of the treating Investigator.
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