Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC

Prior treatment

• Previously received treatment with docetaxel;
• Diagnosed with malignant diseases other than NSCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ);
• Previously received hematopoietic stem cell or bone marrow transplantation;

Other illness

• Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
• Stroke or cardiovascular events within the first 6 months of enrollment;
• Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals;
• Allergies to research drugs or their components;

Other

• When screening, if the QTcF interval is greater than 480 milliseconds, for patients implanted with ventricular pacemakers, QTcF\>500msec；
• The researchers believe that it is not suitable to participate in this study.

• Patients must meet all of the following inclusion criteria to be included in this study:
• Age ≥ 18 years old, regardless of gender;
• Patients with stage IV NSCLC who have failed at least one line of standard treatment regimen:
  • Patients with negative driver genes must have received first line standard treatment (chemotherapy combined with immunotherapy).
  • Patients with positive driver genes must have received at least one line chemotherapy after standard targeted therapy has failed.
  • Definition of driver genes: EGFR (including 19del, L858R, S768I, L861Q, and/or G719X), BRAF V600E, NTRK, MET14 exon skipping mutation, RET, ROS1, etc.
• At least one measurable lesion that meets the RECIST 1.1 criteria exists;
• The laboratory test results meet the following criteria:
  • Hemoglobin ≥ 100 g/L (female), 110g/L (male) ,Neutrophil count ≥ 2×109/L Platelet count ≥ 100×109/L; Creatinine ≤15mg/L or creatinine clearance rate (CrCl) ≥ 60mL/min (Cockcroft Gault formula); Total bilirubin ≤ 1.5xupper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN or ≤ 5×ULN (for patients with liver metastases); Albumin ≥ 30 g/L;
• ECOG PS score 0-2;
• Expected survival time ≥ 3 months;
• Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form until 3 months after the last dose;
• Understand and sign the informed consent form.