Using Trilaciclib with chemotherapy to treat advanced lung cancer with brain 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

This study is testing if adding Trilaciclib to chemotherapy can help people with advanced lung cancer that has spread to the brain feel better and manage side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Province Nanjing Brain Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06332287 on ClinicalTrials.gov

What this trial studies

This interventional study aims to evaluate the effectiveness of Trilaciclib combined with lateral ventricular chemotherapy in patients suffering from advanced non-small cell lung cancer (NSCLC) with leptomeningeal metastasis. Conducted as a single-arm, open-label trial, it will involve 25 participants who meet specific eligibility criteria, including having an implanted Ommaya sac and measurable lesions. The study will also assess the incidence and duration of severe neutropenia during the first treatment cycle.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced NSCLC and leptomeningeal metastasis who meet specific health criteria.

Not a fit: Patients with ECOG-PS scores above 1 or those not meeting the laboratory test criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve outcomes for patients with advanced NSCLC and leptomeningeal metastasis.

How similar studies have performed: While this approach is novel, similar studies have shown promise in treating advanced cancers with targeted therapies.

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.

Where this trial is running

Suzhou, Jiangsu

• Fang Shencun — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: fang S cun, M.D.

Conditions NSCLC