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

INTRODUCTION: 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. METHODS AND ANALYSIS: This is a single-arm, prospective, multicentre phase II study. The primary endpoint is set as the overall response rate according to Response Evaluation Criteria in Solid Tumors V.1.1. Secondary endpoints are progression-free survival, disease control rate and safety. This trial will enrol 22 patients. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCTs051190095).