2023 World Conference on Lung Cancer (Posters)-EP11.04. Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

EP11.04. Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer - PDF(Slides)

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A phase 2 clinical trial is underway to investigate the use of trilaciclib prior to chemotherapy and tislelizumab as a first-line treatment for advanced squamous NSCLC. The combination of chemotherapy and immune checkpoint inhibitors has become the standard treatment for this condition, but it often leads to chemotherapy-induced myelosuppression (CIM) and reduced quality of life for patients. Trilaciclib is a CDK4/6 inhibitor that has shown potential for myeloprotection and immunomodulatory effects. Data from previous clinical trials have demonstrated that trilaciclib can reduce the incidence of CIM and the need for supportive care interventions.<br /><br />The study design involves randomizing patients to receive chemotherapy and tislelizumab with or without trilaciclib every 3 weeks for 4-6 cycles. Afterward, patients will continue to receive tislelizumab with or without trilaciclib until disease progression, intolerable toxicity, withdrawal, or death. If subsequent chemotherapy is required after first-line treatment, trilaciclib will be provided to observe its myeloprotective effect in second-line treatment.<br /><br />The primary endpoint of the study is the occurrence of grade 3 neutrophil count decrease. Secondary endpoints include antitumor efficacy, myeloprotection effects, patient-reported outcomes, supportive care interventions, occurrence of adverse events, and exploratory endpoints related to immune cell subsets and PD-L1 expression.<br /><br />A sample size of 126 patients is required for the study. An interim analysis will be conducted after enrolling 62 participants, and the study will continue if the p-value is less than 0.0015. The final analysis will consider a one-sided p-value of less than 0.0245 statistically significant for the primary endpoint.<br /><br />The study has received ethics approval and began enrolling patients in August 2023. The estimated primary completion date is October 2024, and the study is expected to be completed by December 2025. There are 11 participating sites in China.<br /><br />Overall, this clinical trial aims to evaluate the efficacy and safety of using trilaciclib prior to chemotherapy and tislelizumab in the treatment of advanced squamous NSCLC, with a focus on myeloprotection and patient outcomes.

Asset Subtitle

Yongsheng Wang

Meta Tag

Speaker Yongsheng Wang

Topic Metastatic NSCLC: Immunotherapy - TIPs

Keywords

phase 2 clinical trial

trilaciclib

chemotherapy

tislelizumab

advanced squamous NSCLC

chemotherapy-induced myelosuppression

CDK4/6 inhibitor

myeloprotection

immunomodulatory effects

supportive care interventions