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Trial Title:
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis
NCT ID:
NCT06332287
Condition:
NSCLC
Conditions: Official terms:
Neoplasm Metastasis
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Trilaciclib
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
combination of Trilaciclib and Pemetrexed
Description:
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.
Arm group label:
Trilaciclib+Pemetrexed
Other name:
G1T28
Other name:
CDK 4/6 inhibitor
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fang Shencun
Address:
City:
Suzhou
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
fang S cun, M.D.
Phone:
83728558
Phone ext:
025
Email:
fang1984@aliyun.com
Start date:
May 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Jiangsu Province Nanjing Brain Hospital
Agency class:
Other
Source:
Jiangsu Province Nanjing Brain Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06332287
