Study Protocol

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

Takeshi Masuda, Kazunori Fujitaka, Nobuhisa Ishikawa, Kikuo Nakano, Masahiro Yamasaki, Souichi Kitaguchi, Ken Masuda, Kakuhiro Yamaguchi, Shinjiro Sakamoto, Yasushi Horimasu, Shigeo Kawase, Shintaro Miyamoto, Taku Nakashima, Hiroshi Iwamoto, Naoki Shiota, Tadashi Senoo, Yoshikazu Awaya, Tomohiro Kondo, Takashi Yoshida, Hironobu Hamada, Isao Murakami, Noboru Hattori


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.

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