WCLC 2025 - Posters & ePosters-P3.18.48 Phase II Clinical Trial of Trilaciclib in Combination With PD-1 Inhibitor and Chemotherapy as First-Line Treatment for (NSCLC)

P3.18.48 Phase II Clinical Trial of Trilaciclib in Combination With PD-1 Inhibitor and Chemotherapy as First-Line Treatment for (NSCLC)

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This ongoing single-center, exploratory phase II clinical trial (ChiCTR2500098340) investigates the efficacy and safety of combining Trilaciclib with a PD-1 inhibitor and chemotherapy as a first-line treatment for advanced, driver-negative non-small cell lung cancer (NSCLC). Immune checkpoint inhibitors have become standard for advanced NSCLC, and Trilaciclib, a CDK4/6 inhibitor, has shown in preclinical studies to protect immune cells by transiently arresting lymphocytes in the G1 phase, thereby reducing apoptosis and enhancing immune responses without compromising chemotherapy efficacy.<br /><br />The study enrolls patients aged 18 and older with histologically or cytologically confirmed recurrent or metastatic NSCLC, ECOG performance status 0 or 1, and measurable disease per RECIST v1.1. Exclusions include driver gene mutations, recent hematopoietic growth factor or transfusions, or anticipated need for other antitumor therapies during the study.<br /><br />Participants receive Trilaciclib prior to each chemotherapy cycle for 4-6 cycles, with treatment discontinuation after chemotherapy. Imaging assessments occur every 2 cycles. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), bone marrow protection (incidence of grade 3 neutropenia, thrombocytopenia, anemia), safety, and tolerability.<br /><br />Statistical analysis uses a one-sided test (α=0.025) for PFS and two-sided tests for secondary outcomes, with significance at p≤0.05.<br /><br />Ethics approval was granted on June 1, 2025, recruitment began August 3, 2025, with expected primary completion in October 2026 and study completion by December 2027. The trial is actively recruiting at one site in China.<br /><br />This study aims to determine whether Trilaciclib can improve clinical outcomes and reduce chemotherapy-induced myelosuppression when combined with immunotherapy and chemotherapy in advanced NSCLC patients.

Asset Subtitle

Fei Li

Meta Tag

Speaker Fei Li

Topic Clinical Trials in Progress

Keywords

Trilaciclib

PD-1 inhibitor

chemotherapy

non-small cell lung cancer

NSCLC

immune checkpoint inhibitors

CDK4/6 inhibitor

progression-free survival

myelosuppression

clinical trial