A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis

A Prospective, Single-arm, and Exploratory Phase II Clinical Study of Trilaciclib Combined With Lateral Ventricular Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer With Leptomeningeal Metastasis

To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。

A single-arm, open-label, interventional study was conducted in 25 NSCLC patients with leptomeningeal metastases to observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastases, and to evaluate the incidence and duration of severe neutropenia in the first cycle.

Inclusion Criteria:

• must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender；
• ECOG-PS score of 0-1，and no worsening in the 2 weeks before the study drug；
• expected survival≥12 weeks；
• Advanced non-small cell lung cancer with leptomeningeal metastasis；
• with an Ommaya sac has been implanted；
• At least one measurable lesion meeting RECIST1.1 criteria was present；
• Laboratory tests met 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 (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or 5× ULN (for patients with liver metastases); Albumin ≥ 30 g/L;
• Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
• Voluntarily participate and sign informed consent;

Exclusion Criteria:

• Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
• Stroke or cardio-cerebrovascular event within 6 months before enrollment;
• QTcF interval > 480msec at screening, QTcF > 500msec for patients with implanted ventricular pacemakers;
• Previous hematopoietic stem cell or bone marrow transplantation;
• Allergy to the study drug or its components;
• If the investigator considers that it is not suitable to participate in this study.