Clinical trial NCT06332287: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Jiangsu Province Nanjing Brain Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Trilaciclib
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of severe neutropenia (DSN)
timeFrame: During Trilaciclib plus chemotherapy assessed up to 21 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 2 years
measure: Incidence of grade 3 and 4 hematologic toxicity
timeFrame: during Trilaciclib plus chemotherapy assessed up to 1 years
measure: Incidence of G-CSF treatment
timeFrame: during Trilaciclib plus chemotherapy assessed up to 1 years
measure: Incidence of platelet transfusion
timeFrame: during Trilaciclib plus chemotherapy assessed up to 1 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Fang Shencun
state: Jiangsu
Study officials:
affiliation: Nanjing Brain Hospital
name: fang S cun, M.D.
role: STUDY_DIRECTOR
References: