A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma

Inclusion Criteria:

1. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Gender is not limited;

3. Age ≥18 years old and ≤80 years old;

4. Expected survival time ≥3 months;

5. Patients with histologically or cytologically confirmed locally advanced ormetastatic non-small cell lung cancer;

6. Subjects had to consent to complete ctDNA testing during the screening period;

7. At least one measurable lesion meeting the RECIST v1.1 definition was required;

8. ECOG 0 or 1;

9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as definedby NCI-CTCAE v5.0;

10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

11. No blood transfusion is allowed within 14 days before the first use of the studydrug, and the organ function level must meet the requirements on the premise thatalbumin and colony-stimulating factor are not allowed;

12. Coagulation function: international normalized ratio (INR) ≤1.5, and activatedpartial thromboplastin time (APTT) ≤1.5×ULN;

13. Proteinuria ≤2+ or < 1000mg/24h;

14. For premenopausal women with childbearing potential, a pregnancy test must beperformed within 7 days before starting treatment, serum pregnancy must be negative,and the patient must not be lactating; All enrolled patients (male or female) wereadvised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Exclusion Criteria:

1. Patients with previous docetaxel use;

2. Patients with non-small cell lung cancer (NSCLC) confirmed by histology or cytologyexcept lung squamous cell carcinoma and lung adenocarcinoma;

3. The patients had received chemotherapy or biological therapy within 4 weeks or 5half-lives before the first dose, and had received palliative radiotherapy or moderntraditional Chinese medicine approved by NMPA for anti-tumor treatment within 2weeks;

4. The history of severe cardiovascular and cerebrovascular diseases within six monthsbefore screening;

5. Prolonged QT interval, complete left bundle branch block, III degreeatrioventricular block, frequent and uncontrollable arrhythmia;

6. Complicated with pulmonary diseases leading to severe impairment of lung function;

7. Active autoimmune and inflammatory diseases;

8. Other malignancies diagnosed within 5 years before the first dose;

9. Hypertension poorly controlled by two antihypertensive drugs (systolic bloodpressure &gt; 150 mmHg or diastolic blood pressure &gt; 100 mmHg);

10. Patients with previous or current clinical manifestations or high risk factors suchas ILD, drug-associated pneumonia, and radiation pneumonitis;

11. With untreated central nervous system metastases and/or carcinomatous meningitis/orspinal cord compression;

12. Patients with a history of allergy to the recombinant humanized or human-mousechimeric antibody or to SI-B001 or any of the excipients of the chemotherapy drugsused in this trial;

13. Had a history of autologous or allogeneic stem cell transplantation or organtransplantation;

14. Human immunodeficiency virus antibody positive, active hepatitis B virus infectionor hepatitis C virus infection;

15. Serious infection within 4 weeks before the first dose of study drug;

16. Pleural, pericardial, or abdominal effusion requiring drainage and/or associatedwith symptoms within 4 weeks before the first dose of study drug;

17. Received other investigational drugs or treatments within 4 weeks before the firstdose;

18. A history of severe neurological or psychiatric illness;

19. Imaging examination showed that the tumor had invaded or wrapped the large thoracicvessels or pericardium or heart;

20. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informedconsent;

21. Patients had hemoptysis or hemoptysis within 4 weeks before signing the informedconsent, but those with blood in sputum were not excluded;

22. Had severe infusion reactions (CTCAE grade ≥3) to antibody therapy;

23. Subjects with clinically significant bleeding or obvious bleeding tendency within 4weeks before signing the informed consent;

24. History of intestinal obstruction, inflammatory bowel disease, extensive bowelresection or chronic diarrhea;

25. Who are scheduled to receive the live vaccine or who receive it within 30 daysbefore the first dose;

26. The investigator did not consider it appropriate to apply other criteria forparticipation in the trial.