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

Jiangsu Province Nanjing Brain Hospital

Status and phase: Enrolling; Phase 2

Conditions: NSCLC

Treatments: Drug: combination of Trilaciclib and Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT06332287

2023-NSCLC

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Trilaciclib+Pemetrexed

Experimental group

Description:

Patients were treated with Trilaciclib (240mg/m2, administered within 4 hours before each chemotherapy,Q3W) and pemetrexed (30mg,Q3W) until disease progression as assessed by the investigator according to RECIST 1.1 criteria or withdrawal or discontinuation criteria were met.

Treatment:

Drug: combination of Trilaciclib and Pemetrexed