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
Jiangsu Province Nanjing Brain Hospital
25 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。
Eligibility
Inclusion Criteria9
- 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 Criteria6
- 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.
Interventions
This was a single-arm, exploratory study of the combination of Trilaciclib and Pemetrexed in patients with non-small cell lung cancer with leptomeningeal metastasis. Observed the incidence of chemotherapy-induced myelosuppression, and imaging was performed every six cycles to assess tumor response.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06332287