PADL1NK-005 study design: a phase III trial of fetrastobart vedotin (Fetra-V) vs docetaxel in patients with previously treated tumor PD-L1-positive NSCLC.
完整摘要 · 中文译文
NCT07144280（https://clinicaltrials.gov/study/NCT07144280）。 非小细胞肺癌（NSCLC）是最常见的肺癌类型。NSCLC可高水平表达一种称为程序性死亡配体1（PD-L1）的蛋白。许多癌症利用PD-L1躲避免疫系统（机体的防御系统），从而避免被攻击和清除。Fetrastobart vedotin（Fetra-V）是一种新型疗法，称为抗体偶联药物，由靶向特定蛋白的抗体、抗癌药物以及连接两者的连接子组成。Fetra-V的抗体部分靶向并结合癌细胞表面的PD-L1。Fetra-V进入癌细胞后，连接子释放抗癌药物，杀死癌细胞。PADL1NK-005是一项临床研究，旨在研究Fetra-V用于具有PD-L1表达、已扩散至肺外或无法手术切除、且既往接受过其他药物治疗或对治疗不再应答的NSCLC患者。该研究的目的是评估与接受标准治疗（一种称为多西他赛的化疗药物）的受试者相比，Fetra-V是否延长受试者开始研究治疗后的生存时间（称为总生存期）。还将对受试者进行监测，以了解其在癌症未恶化的情况下生存多长时间（称为无进展生存期）、癌症是否缩小或消失以及副作用。本文介绍PADL1NK-005研究的设计，包括将纳入哪些受试者、如何治疗以及如何监测。
完整摘要 · 英文原文
NCT07144280 (https://clinicaltrials.gov/study/NCT07144280). Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. NSCLC can have high levels of a protein called programmed death ligand 1, or PD-L1. Many cancers use PD-L1 to hide from the immune system (body’s defense) to avoid being attacked and destroyed. Fetrastobart vedotin, or Fetra-V, is a new type of therapy called an antibody–drug conjugate consisting of an antibody that targets a specific protein, an anticancer drug, and a linker that connects the two. The antibody part of Fetra-V targets and attaches to PD-L1 on the surface of cancer cells. After Fetra-V enters the cancer cell, the linker releases the anticancer drug, killing the cancer cell. PADL1NK-005 is a clinical study investigating Fetra-V in people with NSCLC that has PD-L1, has spread beyond the lungs or cannot be removed by surgery, and has previously been treated with other drugs or no longer responds to therapy. The purpose of the study is to evaluate if Fetra-V increases the length of time that participants are alive after starting the study treatment (known as overall survival) compared with participants treated with the standard of care (a chemotherapy drug called docetaxel). Participants will also be monitored to see how long they live without the cancer getting worse (known as progression-free survival), if their cancer has shrunk or disappeared, and for side effects. Here we describe the design of the PADL1NK-005 study, including which participants will be included, how they will be treated, and how they will be monitored.
摘要 待译
NCT07144280 (https://clinicaltrials.gov/study/NCT07144280). Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. NSCLC can have high levels of a protein called programmed death ligand 1, or PD-L1. Many cancers use PD-L1 to hide from the immune system (body’s defense) to avoid being attacked and destroyed. Fetrastobart vedotin, or Fetra-V, is a new type of therapy called an antibody–drug conjugate consisting of an antibody that targets a specific protein, an anticancer drug, and a linker that connects the two.…