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

Phase 2

Recruiting

• Conditions: NSCLC
• Interventions: Drug: combination of Trilaciclib and Pemetrexed

• Registration Number: NCT06332287
• Lead Sponsor: Jiangsu Province Nanjing Brain Hospital

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.

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-11-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trilaciclib+Pemetrexed	combination of Trilaciclib and Pemetrexed	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.

Primary Outcome Measures

Name	Time	Method
Duration of severe neutropenia (DSN)	During Trilaciclib plus chemotherapy assessed up to 21 days	Duration of severe neutropenia in cycle 1

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Up to 2 years	Occurrence and severity of AEs by NCI CTCAE v5.0
Incidence of grade 3 and 4 hematologic toxicity	during Trilaciclib plus chemotherapy assessed up to 1 years	Incidence of grade 3 and 4 hematologic toxicity
Incidence of G-CSF treatment	during Trilaciclib plus chemotherapy assessed up to 1 years	Incidence of G-CSF treatment
Incidence of platelet transfusion	during Trilaciclib plus chemotherapy assessed up to 1 years	Incidence of platelet transfusion

Trial Locations

Locations (1)

Fang Shencun; 🇨🇳 Suzhou, Jiangsu, China