Image

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

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

Recruiting
18 years and older
All
Phase 2

Powered by AI

Overview

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.

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.

Study details
    NSCLC

NCT06332287

Jiangsu Province Nanjing Brain Hospital

14 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.