| Eligibility |
Inclusion Criteria:
1. age = 18 years;
2. pathohistologically or cytologically confirmed small cell lung cancer with measurable
lesions (RECIST 1.1, see Appendix 2);
3. no previous systemic anti-tumor therapy;
4. ECOG 0 or 1 (see Appendix 1);
5. expected survival = 12 weeks;
6. at least one measurable lesion (RECIST 1.1 criteria);
7. basically normal major organ and bone marrow function: a) blood routine: white blood
cells = 4.0 x 109/L, neutrophils = 1.5 x 109/L, platelets = 100 x 109/L, hemoglobin =
90 g/L; b) international normalized ratio (INR) = 1.5 × upper limit of normal (ULN),
and activated partial thromboplastin time (APTT) = 1.5 × ULN; c) liver function: total
bilirubin = 1.5 x ULN; in the absence of liver metastasis, ALT/AST/ALP = 2.5 x ULN; in
the presence of liver metastases,ALT/AST/ALP = 5 x ULN; d) renal function: serum
creatinine = 1.5 x ULN, and creatinine clearance (CCr) 60 mL/min (see Appendix 6); e)
normal cardiac function, left ventricular ejection fraction (LVEF) = 50% by
two-dimensional echocardiography.
8. fully understand the study, voluntarily participate, and sign the informed consent
form.
9. male or female patients of childbearing potential voluntarily use effective
contraceptive methods during the study and within 6 months of the last study
medication, such as double-barrier contraceptive methods, condoms, oral or injectable
contraceptives, intrauterine devices, etc.All female patients will be considered to be
of childbearing potential unless they are naturally postmenopausal, have undergone
artificial menopause, or have undergone sterilization (eg, hysterectomy, bilateral
adnexectomy, or radiation ovarian irradiation).
Exclusion Criteria:
1. previously received systemic anti-tumor therapy for small cell lung cancer;
2. tumors showing significant cavities or necrosis on imaging (CT or MRI)
3. patients with brain or central nervous system metastases, including leptomeningeal
disease, or CT/MRI examination suggesting brain or leptomeningeal lesions) (patients
with brain metastases within 28 days before the completion of randomized treatment and
symptoms from stable enrollment, but brain MRI examination is required, and CT or
intravenous angiography confirms no symptoms of cerebral hemorrhage);
4. patients who are participating in other clinical studies within 4 weeks after the end
of previous clinical studies (except non-interventional studies);
5. Patients who have received chemotherapy, radiotherapy or other investigational
anticancer therapy (except bisphosphonates) within 4 weeks prior to the first dose of
this study. Patients who have previously received local radiotherapy are eligible if
they meet the following criteria: end of radiotherapy more than 4 weeks from the start
of this study (brain radiotherapy more than 2 weeks); in addition, the target lesions
selected for this study are not in the radiotherapy area, or if the target lesions are
within the radiotherapy area, but progression has been confirmed;
6. Other types of malignancy within 5 years or present;
7. patients with active, known, or suspected autoimmune diseases, including allogeneic
organ transplantation, history of allogeneic hematopoietic stem cell transplantation,
history of HIV-positive or history of acquired immunodeficiency syndrome (AIDS);
8. active or previously documented inflammatory bowel disease (e.g., Crohn's disease,
ulcerative colitis);
9. non-remitting toxicity from previous treatment, more than CTC AE (4.0) grade 1,
excluding alopecia;
10. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or
APTT ULN > 1.5), with bleeding tendency or receiving thrombolytic and anticoagulant
therapy, clinically significant hemoptysis (hemoptysis more than half a tablespoon
daily; or clinically significant bleeding symptoms or bleeding tendency within 4 weeks
before grouping, such as gastrointestinal bleeding, hemorrhagic gastric ulcer
(including gastrointestinal perforation and/or fistula, but gastrointestinal
perforation or fistula has been surgically removed, admission is allowed), baseline
fecal occult blood + + or more, unhealed wounds, ulcers or fractures;
11. urine routine showed urine protein = + +, or urine protein = 1.0 g within 24 hours;
12. Uncontrolled hypertension (SBP = 160 mmHg and DBP = 100 mmHg despite optimal medical
therapy);
13. Patients with severe cardiovascular disease: myocardial ischemia or myocardial
infarction above grade II, poorly controlled arrhythmia; according to NYHA criteria,
grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50%
by echocardiography;
14. Patients with NCI-CTCAE grade II or higher peripheral neuropathy, except due to
trauma;
15. Interstitial lung disease, uncontrolled moderate to large serous effusion (including
pleural effusion, ascites, and pericardial effusion) after pumping therapy,
exacerbation of chronic obstructive pulmonary disease requiring intravenous
antibiotics within 28 days, active pulmonary infection, and/or acute bacterial or
fungal respiratory disease;
16. There are factors that significantly affect the absorption of oral drugs, such as
inability to swallow, chronic diarrhea and intestinal obstruction;
17. Venous thromboembolic events such as cerebrovascular accidents (including transient
ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis,
pulmonary embolism within 6 months prior to enrollment;
18. Has received a live or attenuated vaccine within 30 days prior to the first dose of
dulizumab, or plans to receive a live or attenuated vaccine during the study;
19. Known history of severe hypersensitivity to other monoclonal antibodies;
20. Known history of psychotropic drug abuse, alcohol abuse, or drug abuse;
21. Active hepatitis uncontrolled after treatment (hepatitis B: HBsAg positive and HBV DNA
more than 1 x 10 ^ 4 copies/ml; hepatitis C: HCV RNA positive and abnormal liver
function); combined hepatitis B and C infection;
22. Have other serious diseases that, in the opinion of the investigator, jeopardize the
patient 's safety or affect the patient' s completion of the study;
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