WCLC 2025 - Posters & ePosters-P3.18.24 A Multicenter, Open Label, Dual Cohort Study: The Efficacy and Safety of Vinorelbine Combined With a First-Line Treatment for Metastatic NSCLC

P3.18.24 A Multicenter, Open Label, Dual Cohort Study: The Efficacy and Safety of Vinorelbine Combined With a First-Line Treatment for Metastatic NSCLC

Back to course

Pdf Summary

This multicenter, open-label, dual-cohort phase II study (XJTU1AF2024LSYY-130) investigates the efficacy and safety of vinorelbine plus cisplatin (NP regimen) combined with the PD-1 inhibitor sintilimab, with or without bevacizumab, as first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC) without driver gene mutations. The trial aims to address the limited evidence for vinorelbine-based chemoimmunotherapy combinations in this setting, motivated by prior findings suggesting acceptable safety but uncertain efficacy in combining vinorelbine with immune checkpoint inhibitors.<br /><br />Two cohorts are enrolled across 3-5 centers in China: Cohort 1 (n=24) receiving NP plus sintilimab over 18 months enrollment with 12 months follow-up, and Cohort 2 (n=63) receiving NP, sintilimab, and bevacizumab until disease progression or unacceptable toxicity. Eligible patients include adults 18-65 years old with ECOG performance status 0-1, no prior systemic therapy, available tumor tissue for PD-L1 testing, and adequate organ function. Exclusion criteria encompass squamous or small cell histology, active CNS metastases, autoimmune disease, recent major surgery or radiation, uncontrolled effusions, significant bleeding risks, and other conditions affecting safety.<br /><br />The primary endpoint is objective response rate; secondary endpoints include efficacy outcomes, safety profile, and quality of life, with exploratory analysis of circulating tumor DNA dynamics. Treatment involves vinorelbine (60 mg/m² days 1 and 8 every 3 weeks), cisplatin (75 mg/m² day 1 every 3 weeks), sintilimab (200 mg day 1 every 3 weeks), and bevacizumab (15 mg/kg day 1 every 3 weeks in Cohort 2).<br /><br />This study seeks to provide robust clinical evidence on the combination of vinorelbine-based chemotherapy with immunotherapy, potentially offering a novel first-line treatment option for metastatic non-squamous NSCLC patients lacking driver mutations. Results may clarify the benefit-risk profile and inform future treatment guidelines.

Asset Subtitle

Xiao Fu

Meta Tag

Speaker Xiao Fu

Topic Clinical Trials in Progress

Keywords

vinorelbine

cisplatin

sintilimab

bevacizumab

non-squamous non-small cell lung cancer

metastatic NSCLC

PD-1 inhibitor

chemoimmunotherapy

phase II clinical trial

objective response rate