[Translation] A phase III randomized, double-blind, multicenter clinical study of carboxyamide triazole capsules combined with NP versus placebo combined with NP in the treatment of patients with stage IV non-small cell lung cancer who had never been treated.
在Ⅳ期非小细胞肺癌(NSCLC)患者中比较100mg CAI胶丸与长春瑞滨+顺铂联用和安慰剂与长春瑞滨+顺铂联用作为一线方案治疗的有效性和安全性。 主要疗效指标:无进展生存期(PFS)。 次要疗效指标:客观有效率(CR+PR)、疾病控制率 (CR+PR+SD)、总生存期(OS)、生活质量。
[Translation] To compare the efficacy and safety of 100 mg CAI capsules in combination with vinorelbine + cisplatin and placebo in combination with vinorelbine + cisplatin as first-line treatment in patients with stage IV non-small cell lung cancer (NSCLC). Primary efficacy indicator: progression-free survival (PFS). Secondary efficacy indicators: objective response rate (CR+PR), disease control rate (CR+PR+SD), overall survival (OS), and quality of life.