This study is a prospective, single arm phase II study aimed at patients with locally advanced or metastatic non-small cell lung cancer undergoing second-line or beyond treatment. The aim is to evaluate the bone marrow protective effect of trilaciclib before docetaxel chemotherapy for locally advanced or metastatic NSCLC.
Age ≥ 18 years old, regardless of gender;
At least one measurable lesion that meets the RECIST 1.1 criteria exists;
ECOG PS score 0-2;
Expected survival time ≥ 3 months;
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);
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;
Single group
Trilaciclib combined with Docetaxel
DrugTrilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to chemotherapy. Docetaxel: 75mg/m2, iv. infusion for 1 hour on days 1 of each 21-day cycle, totaling 4 cycles of medication.
Incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Incidence rate of grade 3 or 4 thrombocytopenia
Incidence rate of grade 3 or 4 anemia during chemotherapy treatment
Incidence rate of febrile neutropenia
Usage rate of symptomatic treatments for myelosuppression
such as granulocyte colony-stimulating factor (G-CSF) (not for prevention), thrombopoietin (TPO), interleukin-11 (IL-11), erythropoiesis-stimulating agents (ESA), iron supplements, etc
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