Clinical trial · Interventional
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis
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
NCT06332287CI-TRIAL-00075463unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combination of Trilaciclib and Pemetrexed | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trilaciclib+Pemetrexed
- description
- 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.
- interventionNames
- Drug: combination of Trilaciclib and Pemetrexed
Primary outcomes (1)
- measure
- Duration of severe neutropenia (DSN)
- timeFrame
- During Trilaciclib plus chemotherapy assessed up to 21 days
- description
- Duration of severe neutropenia in cycle 1
Secondary outcomes (4)
- measure
- Incidence of Treatment-Emergent Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.