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

J

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)

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

Trial contacts and locations

1

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Central trial contact

fang S cun, M.D.

Data sourced from clinicaltrials.gov

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