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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332287
• Other study ID #: 2023-NSCLC
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Jiangsu Province Nanjing Brain Hospital
• Contact: fang S cun, M.D.
• Phone: 83728558
• Email: fang1984[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• NSCLC

Intervention

Drug:
• combination of Trilaciclib and Pemetrexed
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

Country	Name	City	State
China	Fang Shencun	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Nanjing Brain Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of severe neutropenia (DSN)	Duration of severe neutropenia in cycle 1	During Trilaciclib plus chemotherapy assessed up to 21 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Occurrence and severity of AEs by NCI CTCAE v5.0	Up to 2 years
Secondary	Incidence of grade 3 and 4 hematologic toxicity	Incidence of grade 3 and 4 hematologic toxicity	during Trilaciclib plus chemotherapy assessed up to 1 years
Secondary	Incidence of G-CSF treatment	Incidence of G-CSF treatment	during Trilaciclib plus chemotherapy assessed up to 1 years
Secondary	Incidence of platelet transfusion	Incidence of platelet transfusion	during Trilaciclib plus chemotherapy assessed up to 1 years