Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria:

1. Patients must sign the informed consent form and commit to complying with therequirements of this study.
2. Male or female, ≥ 18 years of age, ≤ 70 years of age.
3. Histologically or cytologically confirmed NSCLC, diagnosed as stage IV or stageIIIB-IIIC not amenable to radical surgery according to the IASLC (InternationalAssociation for the Study of Lung Cancer) 8th edition staging system.
4. The subject has at least one evaluable lesion (measurable or non-measurable) by theRECIST 1.1.
5. The subject must have received a prior systemic chemotherapy (includingneoadjuvant/adjuvant therapy) with a platinum-containing regimen, and are allowed tohave ≤ 2 prior lines of chemotherapy for advanced cancer (excludingneoadjuvant/adjuvant chemotherapy).
6. Patients without driver genes can be treated with/ not be treated with PD-1/PD-L1inhibitors previously.
7. EGFR-positive patients are required to have received at least one or more EGFR-TKI (including Erlotinib, Gefitinib, Icotinib, Afatinib, Osimertinib, or other TKI forEGFR mutations, etc.), with disease progression or intolerance during or aftertreatment.

• Patients having had disease progression or intolerance to Osimertinib or otherthird-generation EGFR-TKI are eligible for enrollment (regardless of priortreatment with first/second-generation EGFR-TKI)
• Patients having had disease progression or intolerance to first- orsecond-generation EGFR-TKI (e.g., Erlotinib, Gefitinib, Icotinib, Afatinib, etc.)without evidence of EGFR T790M mutation after this treatment are eligible forenrollment.

8. ALK fusion-positive patients who have received at least one or more ALK-TKI therapiesand experienced disease progression or intolerance during or after treatment. -Patients having had disease progression or intolerance to the third-generationALK-TKI Lorlatinib are eligible for enrollment (regardless of prior treatment withfirst- or second-generation ALK-TKI).
9. Baseline routine blood tests within 1 week prior to enrollment is normal, with CTCAEgrade ≤1 (based on normal values at each site's laboratory). No rhG-CSF use and noblood transfusion/EPO etc. within 14 days prior to enrollment.

• White blood cell count (WBC) ≥4.0 × 109/L.
• Neutrophil count (ANC) ≥ 1.5 × 109/L.
• platelet count (PLT) ≥ 100 × 109/L
• Hemoglobin ≥9.0 g/dL.

10. Blood biochemistry test result is normal within 1 week prior to enrollment, with CTCAEgrade ≤1 (based on normal values at each site's laboratory).

• Total bilirubin (TBIL) ≤ 1.5× the upper limit of normal value (ULN)
• Serum Glutamic Pyruvic Transaminase/Alanine Amino transferease (SGPT /ALT) ≤ 3×ULN (in the case of liver metastases ≤ 5 × ULN)
• Serum Glutamic-oxaloacetic Transaminase/Aspartate Aminotransferase (SGOT /AST) ≤ 3× ULN (in the case of liver metastases ≤ 5 × ULN)
• Creatinine clearance (Ccr) ≥60 ml/min.

11. ECOG performance status 0-1.
12. Fertile males and females of childbearing potential must agree to use effectivecontraception during the study and within 90 days after the last dose. The blood orurine pregnancy test for female patients of childbearing age prior to enrollment mustbe negative.
13. Patients with a life expectancy of more than 3 months.

Exclusion Criteria:

1. Patients who had other malignancies within the past 5 years, excluding cured basalcell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroidcancer.
2. Patients who have received antitumor therapy, including chemotherapy, radiotherapy,biologic therapy, targeted therapy, immunotherapy, or antitumor herbal therapy, within 4 weeks or 5 half-lives (≥ 2 weeks), whichever is shorter, prior to the first dose ofthe study drug.
3. Patients who have had surgery of their major organs (excluding puncture biopsy) or hadmajor injuries within 4 weeks prior to the first dose of study drug, or requireelective surgery during the study.
4. Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥2
5. Patients with known allergic reactions to any ingredient of the study drug.
6. Patients who have previously been treated with docetaxel.
7. Patients who are pregnant (positive result from the pregnancy test) or lactating.
8. Patients whose prior adverse reactions to anti-tumor therapy have not recovered toCTCAE 5.0 grade ≤1 (except for toxicity such as alopecia which poses no safety risk inthe judgment of the investigator).
9. Patients with symptomatic CNS metastases or meningeal metastases, or uncontrollablemetastases, i.e., metastatic lesion progression confirmed by examination within 2months after radiotherapy or other localized treatment, or those who are unsuitablefor enrollment in the judgment of the investigator.
10. Patients with uncontrollable bone metastases, i.e., patients who have had fracture orhave the risk of fracture in recent days, patients who need surgery or localizedradiotherapy in recent days, and patients under critical conditions in the judgment ofthe investigator.
11. Patients with uncontrollable pleural effusion, pericardial effusion, or ascitesrequiring repeated drainage (once a month or more frequently)
12. Patients with an active infection that currently requires systemic anti-infectivetherapy
13. Patients having a history of immunodeficiency, including a positive HIV antibody test.
14. Patients with active hepatitis B/C infection; patients with known active infection ofsyphilis.
15. Patients with history of severe cardiovascular disease, including but not limited to:

• Serious cardiac rhythm or conduction abnormalities such as ventriculararrhythmias requiring clinical intervention, second- to third- degreeatrioventricular block; mean QTcF >470ms from 3 12-lead ECGs at rest.
• Patients who had acute coronary syndrome, congestive heart failure, aorticdissection, stroke or other cardiovascular events at Class 3 or higher within 6months prior to the first dose.
• Patients with clinically uncontrollable hypertension.
• Patients with other high-risk cardiac conditions in the judgment of theinvestigator.

16. Patients with uncontrolled diabetes mellitus.
17. Patients with mental disorders or poor compliance.
18. Patients who concurrently participate in another clinical trial or use anotherinvestigational treatment.
19. Subjects who, in the opinion of the investigator, have a history of other serioussystemic diseases, or other reasons that make participation in this trial inadvisable.