Clinical trial

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

Name

2023-NSCLC

Description

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

Trial arms

Trial start

2023-05-01

Estimated PCD

2024-11-01

Trial end

2025-06-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Trilaciclib+Pemetrexed

Other names:

G1T28, CDK 4/6 inhibitor

Size

Primary endpoint

Duration of severe neutropenia (DSN)

During Trilaciclib plus chemotherapy assessed up to 21 days

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Trilaciclib', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}

Updated at

2024-03-27

1 organization

1 product

1 indication

Organization

Jiangsu Province Nanjing Brain Hospital

Product

Trilaciclib + Pemetrexed

Indication

NSCLC