NSCLC
Conditions
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。
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.
Interventions
DRUGcombination 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.
Sponsors
Jiangsu Province Nanjing Brain Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Trilaciclib
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of severe neutropenia (DSN) | During Trilaciclib plus chemotherapy assessed up to 21 days | Duration of severe neutropenia in cycle 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Up to 2 years | Occurrence and severity of AEs by NCI CTCAE v5.0 |
| Incidence of grade 3 and 4 hematologic toxicity | during Trilaciclib plus chemotherapy assessed up to 1 years | Incidence of grade 3 and 4 hematologic toxicity |
| Incidence of G-CSF treatment | during Trilaciclib plus chemotherapy assessed up to 1 years | Incidence of G-CSF treatment |
| Incidence of platelet transfusion | during Trilaciclib plus chemotherapy assessed up to 1 years | Incidence of platelet transfusion |
Countries
China
Contacts
Primary Contactfang S cun, M.D.
Outcome results
None listed