彭布罗利珠单抗
医学
内科学
肿瘤科
杜瓦卢马布
奥拉帕尼
肺癌
人口
放化疗
安慰剂
临床终点
卡铂
随机对照试验
癌症
放射治疗
化疗
顺铂
病理
免疫疗法
聚ADP核糖聚合酶
化学
替代医学
基因
环境卫生
聚合酶
生物化学
作者
Andreas Rimner,W. Victoria Lai,Raffaele Califano,Salma K. Jabbour,Charles M. Rudin,Corinne Faivre–Finn,Byoung Chul Cho,Terufumi Kato,Jinming Yu,Wyatt Chafin,Li Yu,Bin Zhao,Lauren A. Byers
标识
DOI:10.1016/j.cllc.2022.04.005
摘要
Background The current standard of care for patients with newly diagnosed limited-stage small-cell lung cancer (SCLC) is concurrent chemoradiotherapy (CCRT). The prognosis remains poor due to the aggressiveness and high risk of progression or relapse of SCLC even if an initial response is achieved. Therefore, there is an urgent unmet clinical need in this population. The multicenter, phase 3, randomized, placebo-controlled, double-blind KEYLYNK-013 study evaluates the addition of pembrolizumab to CCRT followed by pembrolizumab with or without olaparib in participants with previously untreated limited-stage SCLC. (ClinicalTrials.gov: NCT04624204). Methods Eligible participants aged ≥18 years with newly diagnosed, pathologically confirmed, limited-stage (ie, stage I-III) SCLC will be randomized 1:1:1 to CCRT (ie, etoposide plus carboplatin or cisplatin for 4 cycles and standard thoracic radiotherapy) plus pembrolizumab (Groups A and B) or CCRT plus placebo (Group C). In the absence of disease progression, participants will receive pembrolizumab plus placebo (Group A), pembrolizumab plus olaparib (Group B), or placebo (Group C). Dual primary endpoints are progression-free survival per RECIST version 1.1 by blinded independent central review and overall survival. Results Enrollment began in December 2020 and is ongoing at approximately 150 sites. Conclusions KEYLYNK-013 will provide valuable information on the efficacy and safety of pembrolizumab plus CCRT and pembrolizumab with or without olaparib post CCRT in participants with limited-stage SCLC.
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