| Eligibility |
Inclusion Criteria:
1. Both men and women, age = 18 years.
2. Small Cell Lung Cancer confirmed by histology or cytology.
3. Extensive-stage SCLC (defined as AJCC 8th Edition IV (Tany,Nany,M1a/b/c), or T3-4
cannot be included in a tolerable radiotherapy plan due to multiple pulmonary nodules
or tumor/nodule size).
4. Have not received first-line systemic treatment for ES-SCLC in the past.
5. surgery and adjuvant therapy for cure, such as radiotherapy and chemotherapy, were
performed in the past, and there was no treatment interval of at least 6 months from
the last chemotherapy, radiotherapy or radiotherapy or chemotherapy to the diagnosis
of ES-SCLC.
6. ECOG PS 0,1.
7. The estimated survival = 8 weeks.
8. CT or MRI scan with at least one measurable lesion (according to RECIST v1.1) = 28
days before administration of the first study drug.
9. Male partners of childbearing age and female subjects of childbearing age must have
contraception within 6 months after signing the informed consent form to the last
study of the drug, and the (HCG) test of human chorionic gonadotropin in blood / urine
of female subjects of childbearing age must be negative 7 days before the first use of
the drug.
10. Before the first dose , the laboratory test values meets the following conditions: (1)
Blood routine test (corrected without blood transfusion and hematopoietic factor drugs
within 14 days before screening): White blood cell count ((WBC) = 3.0x10^9); absolute
neutrophil count ((ANC)) = 1.5x10^9; platelet (PLT) = 100x10^9; hemoglobin content
((hGB) = 90g). (2) Liver function: aspartate aminotransferase (AST) = 2.5 ULN, alanine
liver aminotransferase (ALT) = 2.5 ULN; ALT and AST < 5 ULN; serum total bilirubin
(TBIL) = 1.5 ULN; albumin (ALB) = 30 g L; (3) Renal function: serum creatinine = 1.5
ULN or creatinine clearance rate (Ccr) = 40 mL/min (Cockcroft/Gault formula). (4)
Coagulation function: international standardized ratio (INR) = 1.5 ULN, activated
partial thromboplastin time (APTT) = 1.5 ULN; (5) alkaline phosphatase (ALP) = 2.5
ULN, bone metastasis subjects, ALP = 5 ULN.
11. Tumor tissue samples that can meet the the requirements of PD-L1 expression detection
can be provided within 4 weeks from the screening period to 4 weeks after enrollment.
12. Sign informed consent form voluntarily,have good compliance and cooperation with
follow-up.
Exclusion Criteria:
1. Received any T cell costimulatory or immune checkpoint inhibitors before entering the
group, including, but not limited to, cytotoxic T lymphocyte associated antigen-4
(CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T
cells; previously received anti-vascular endothelial growth factor (VEGF) or vascular
endothelial growth factor receptor (VEGFR) therapy.
2. Active brain metastasis or meningeal metastasis. Patients with brain metastasis after
treatment need to meet the following conditions: asymptomatic; no imaging evidence of
progress = 4 weeks after treatment; completion of treatment within 7 days before the
first dose of the study drug; and no need to receive systemic corticosteroids (> 10mg/
prednisone or equivalent) less than 14 days before the first dose of the study drug.
If a new asymptomatic brain metastasis is found during the screening period,
radiotherapy and/or surgery are required.
If all other criteria are met after treatment, additional brain scans are not required
before randomization.
3. The completion time of radiotherapy for the brain and palliative radiotherapy for the
focus of bone disease is less than 7 days before the first dose of the study drug.
4. Active, known or suspected autoimmune diseases, including, but not limited to,
myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,
rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with
antiphospholipid syndrome, Wegener's granuloma, Sjogren's syndrome, Guillain-Barre
syndrome, multiple sclerosis, vasculitis or glomerulonephritis. Only cases of residual
hypothyroidism due to autoimmune thyroiditis, controlled type I diabetes, or no
recurrence expected in the absence of external stimulation that require hormone
replacement therapy can be included. Only patients with eczema, psoriasis,
neurodermatitis or vitiligo (psoriatic arthritis patients will need to be excluded)
can be enrolled in the group if they meet the following conditions: the area covered
by the rash must be less than 10% of the body surface area; the disease is well
controlled at the baseline level, requiring only inefficient topical steroids, and
those with no acute exacerbation in the past 12 months can be enrolled.
5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated
drainage (once a month or more frequently). Patients who use indwelling catheters are
allowed to be selected.
6. Corticosteroids (> 10 mg/ prednisone or equivalent dose) or other immunosuppressants
were used within 14 days before the first study. Inhalation or topical use of steroids
and adrenal replacement steroids are allowed in the absence of active autoimmune
disease; for patients receiving short-term, systemic immunosuppressive therapy, for
example, glucocorticoids for nausea, vomiting, or allergic reaction management or
preventive use can be admitted after consultation with the sponsor. Allow the use of
salt corticosteroids in the treatment of postural hypotension and the use of low-dose
glucocorticoid supplements in the treatment of adrenocortical insufficiency.
7. Patients who had been vaccinated or planned to receive live vaccines within 4 weeks
before drug administration were studied for the first time.
8. Major surgery was performed within 4 weeks before drug administration, or major
surgery was planned during the study period.
9. Interstitial pneumonia (ILD) disease, drug-induced pneumonia, radiation pneumonia
requiring steroid treatment or active pneumonia with clinical symptoms.
10. Active pulmonary tuberculosis or screening patients with a history of active pulmonary
tuberculosis infection within 1 year before treatment, whether treated or not.
11. Uncontrolled cardiovascular diseases, such as: (1) New York Heart Association (NYHA)
grade 2 or above heart failure (2) unstable angina pectoris (3) myocardial infarction
or cerebrovascular accident within 6 months (4) clinically significant
supraventricular or ventricular arrhythmias need to be treated.
12. Uncontrolled active infections (e.g. need intravenous antibiotics, antifungal or
antiviral therapy).
13. Active hepatitis B or C (unless HBV-DNA titer < 500IU/mL or copy number <
1000copies/ml, HCV-RNA negative after antiviral treatment can be included in), HIV
positive or known history of acquired immunodeficiency syndrome.
14. Known allergies to research drugs or excipients, and known severe allergic reactions
to any monoclonal antibody; allergic history of carboplatin or etoposide.
15. Patients who have previously received allogeneic bone marrow transplantation or solid
organ transplantation.
16. Other malignant tumors occurred less than 5 years before the first dose, except for
fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer,
local prostate cancer after radical resection, and ductal carcinoma in situ after
radical mastectomy.
17. Have been treated with any other experimental drugs or participated in another
interventional clinical study within 4 weeks before signing ICF.
18. Pregnant or lactating women.
19. Known cases of mental illness, alcohol abuse, inability to quit smoking, drug use or
substance abuse.
20. Other situations judged by the investigators to be unsuitable for inclusion in the
group
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