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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Fang Shencun
Suzhou, Jiangsu, China
RECRUITINGDuration of severe neutropenia (DSN)
Duration of severe neutropenia in cycle 1
Time frame: During Trilaciclib plus chemotherapy assessed up to 21 days
Incidence of Treatment-Emergent Adverse Events
Occurrence and severity of AEs by NCI CTCAE v5.0
Time frame: Up to 2 years
Incidence of grade 3 and 4 hematologic toxicity
Incidence of grade 3 and 4 hematologic toxicity
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of G-CSF treatment
Incidence of G-CSF treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of platelet transfusion
Incidence of platelet transfusion
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
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