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

NCT06332287 | Recruiting Phase 2

• 1 other identifier: 2023-NSCLC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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。

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Duration of severe neutropenia (DSN)

  Duration of severe neutropenia in cycle 1

  During Trilaciclib plus chemotherapy assessed up to 21 days

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  Up to 2 years

• Incidence of grade 3 and 4 hematologic toxicity

  during Trilaciclib plus chemotherapy assessed up to 1 years

• Incidence of G-CSF treatment

  during Trilaciclib plus chemotherapy assessed up to 1 years

• Incidence of platelet transfusion

  during Trilaciclib plus chemotherapy assessed up to 1 years

Study Arms (1)

Trilaciclib+Pemetrexed

EXPERIMENTAL

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.

Drug: combination of Trilaciclib and Pemetrexed

Interventions

combination of Trilaciclib and Pemetrexed DRUG

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.

Also known as: G1T28, CDK 4/6 inhibitor

Trilaciclib+Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Fang Shencun

Suzhou, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• fang S cun, M.D.

  Nanjing Brain Hospital

  STUDY DIRECTOR

Central Study Contacts

fang S cun, M.D.

CONTACT

83728558; fang1984@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Trilaciclib

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 27, 2024
• Study Start: May 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)