Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study
comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as
maintenance treatment in patients with locally advanced or metastatic NSCLC, who have
received and responded to prior platinum-doublet systemic chemotherapy. The primary objective
of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally
advanced or metastatic NSCLC patients with or without vandetanib maintenance.

本研究为一项多中心、随机、双盲、安慰剂对照的II期临床试验，旨在对比凡德他尼（vandetanib，每日300mg）联合最佳支持治疗（best supportive care, BSC）与安慰剂联合最佳支持治疗作为维持治疗方案，用于既往接受含铂双药全身化疗且获得缓解的局部晚期或转移性非小细胞肺癌（non-small cell lung cancer, NSCLC）患者。本研究的主要研究目的为对比伴或不伴凡德他尼维持治疗的局部晚期或转移性非小细胞肺癌患者的3个月无进展生存期（Progression Free Survival, PFS）率。