Prospective, multicentre, single-arm phase II trial of pembrolizumab combined with carboplatin and pemetrexed in elderly patients with advanced, non-squamous non-small cell lung cancer.

Triplet regimen of carboplatin or cisplatin with pemetrexed and pembrolizumab is a standard treatment for patients with advanced, chemo-naïve, non-squamous non-small cell lung cancer. However, subgroup analysis for patients aged ≥75 years indicated that elderly patients who received the triplet regimen may have had shorter survival times than if they had chemotherapy alone (HR of 2.09). Treatments in the elderly are not always as effective or safe as for non-elderly patients, so there remains concern over whether the triplet regimen can be widely used in the elderly. This is a single-arm, prospective, multicentre phase II study. The primary endpoint is set as the overall response rate according to This study was approved by the Wakayama Medical University Central Review Board on 2 December 2019 (approval number: W-32). Patients have been enrolled since February 2020. As the study will complete accrual in January 2022, results will be submitted for publication in peer-reviewed medical journals within 2023 and international scientific meetings. This study will provide significant information on whether the triplet regimens are clinically beneficial to elderly patients. Japan Registry of Clinical Trials (jRCTs051190095).

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Déclaration de conflit d'intérêts

Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare no support from any organisation for the submitted work; YO has received personal fees from MSD K.K. and Eli Lilly, YH received personal fees from Bristle-Myers Squibb, NY received personal fees from MSD K.K. and Eli Lilly, Bristle-Myers Squibb, and Nichi-iko Pharmaceutical; no other relationships or activities that could appear to have influenced the submitted work.