%0 Journal Article %T Treatment rationale and design of the PROLONG study: safety and efficacy of pembrolizumab as first-line therapy for elderly patients with non-small cell lung cancer %A Masuda, Takeshi %A Fujitaka, Kazunori %A Ishikawa, Nobuhisa %A Nakano, Kikuo %A Yamasaki, Masahiro %A Kitaguchi, Souichi %A Masuda, Ken %A Yamaguchi, Kakuhiro %A Sakamoto, Shinjiro %A Horimasu, Yasushi %A Kawase, Shigeo %A Miyamoto, Shintaro %A Nakashima, Taku %A Iwamoto, Hiroshi %A Shiota, Naoki %A Senoo, Tadashi %A Awaya, Yoshikazu %A Kondo, Tomohiro %A Yoshida, Takashi %A Hamada, Hironobu %A Murakami, Isao %A Hattori, Noboru %J Journal of Thoracic Disease %D 2020 %B 2020 %9 %! Treatment rationale and design of the PROLONG study: safety and efficacy of pembrolizumab as first-line therapy for elderly patients with non-small cell lung cancer %K %X Background: Pembrolizumab is recommended as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and a Programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) of ≥50% without driver mutations. However, the safety and efficacy were not investigated among patients who were ≥75 years old. Methods: This open-label single-arm phase II study is designed to evaluate pembrolizumab as first-line therapy for patients who are ≥75 years old with advanced NSCLC and a PD-L1 TPS of ≥50% without driver mutations. The primary endpoint is progression-free survival, and the secondary endpoints are overall survival, objective response rate, safety, and quality of life. Recruitment started in October 2017 and is expected to continue for approximately 3 years. Conclusions: Given the currently poor prognosis of elderly patients with advanced NSCLC, we hope that the findings of this study will facilitate more effective treatment in this setting. %U https://jtd.amegroups.org/article/view/34848 %V 12 %N 3 %P 1079-1084 %@ 2077-6624