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首页> 外文期刊>Clinical lung cancer >A multicenter randomized phase IIb efficacy study of Vx-001, a peptide-based cancer vaccine as maintenance treatment in advanced non-small-cell lung cancer: Treatment rationale and protocol dynamics
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A multicenter randomized phase IIb efficacy study of Vx-001, a peptide-based cancer vaccine as maintenance treatment in advanced non-small-cell lung cancer: Treatment rationale and protocol dynamics

机译：Vx-001，一种基于肽的癌症疫苗，作为晚期非小细胞肺癌维持治疗的多中心随机IIb期疗效研究：治疗原理和方案动态

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We present the treatment rationale and study design of a multicenter, open-label, randomized, 2-arm, phase IIb study. Patients with stage IV or recurrent stage I to III non-small-cell lung cancer (NSCLC) whose disease does not progress after 4 cycles of first-line platinum-based chemotherapy will be randomized in a 1:1 ratio to 1 of 2 study arms. Patients will receive the cancer vaccine Vx-001 + Montanide ISA51 VG (Seppic, Paris, France) adjuvant subcutaneously, at a dose of 2 mg, or placebo + Montanide ISA51 VG adjuvant subcutaneously. The vaccination protocol comprises 2 injections with the TYR-Vx001 or placebo (1 at day 0 and another at week 3) and 4 injections with the ARG-Vx001 or placebo, at weeks 6, 9, 12, and 15. After the treatment assessment at week 18, patients will receive the ARG-Vx001 or placebo every 12 weeks starting from week 27 until disease progression, unacceptable toxicity, withdrawal of informed consent, or death. The primary end point of this study is the survival rate at 12 months. Secondary end points include time-to-event comparison of overall survival and comparison of time to treatment failure. Exploratory objectives include comparison of disease control rate after the end of subsequent second-line treatments, comparisons of vaccine immune responses, comparison of survival rate at 12 months in patients with vaccine-induced immune response detected after the second and sixth injections, identification of biomarkers on lymphocytes and on tumors, and comparison of safety and tolerability.
机译：我们提出了多中心，开放标签，随机，2组，IIb期研究的治疗依据和研究设计。 IV期或复发的I至III期非小细胞肺癌（NSCLC）患者在4周期一线铂类化疗后疾病仍未进展的患者，将以1：1的比例随机分配至2个研究中的1个武器。患者将以2 mg的剂量皮下接受癌症疫苗Vx-001 + Montanide ISA51 VG（Seppic，法国巴黎）佐剂，或通过皮下注射安慰剂+ Montanide ISA51 VG佐剂。疫苗接种方案包括在第6、9、12和15周使用TYR-Vx001或安慰剂进行2次注射（第0天1次，在第3周进行另一次），并在ARG-Vx001或安慰剂中进行4次注射。从第27周开始，在第18周时，患者将每12周接受ARG-Vx001或安慰剂，直到疾病进展，不可接受的毒性，撤回知情同意或死亡。这项研究的主要终点是12个月的生存率。次要终点包括总生存时间的事件比较和治疗失败的时间比较。探索性目标包括比较后续二线治疗结束后的疾病控制率，比较疫苗免疫反应，比较在第二次和第六次注射后检测到疫苗诱导的免疫反应的患者在12个月时的存活率，比较生物标志物以及淋巴细胞和肿瘤的安全性和耐受性比较。

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