A randomized controlled phase III trial protocol: perioperative pirfenidone therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis to confirm the preventative effect against postoperative acute exacerbation: the PIII-PEOPLE study (NEJ034)

Journal of Thoracic Disease

article

Yuichi Sakairi¹  Ichiro Yoshino¹  Takekazu Iwata²  Shigetoshi Yoshida³  Kazuyoshi Kuwano⁴  Arata Azuma⁵  Shuji Sakai⁶  Kunihiko Kobayashi⁷ 

[1] Department of General Thoracic Surgery, Chiba University Graduate School of Medicine;Division of Thoracic Surgery, Chiba Cancer Center;Department of Thoracic Surgery, International University of Health and Welfare School of Medicine;Division of Respiratory Diseases, Department of Internal Medicine, The Jikei University School of Medicine;Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School;Department of Diagnostic Imaging and Nuclear Medicine, Tokyo Women’s Medical University;1 Department of General Thoracic Surgery, Chiba University Graduate School of Medicine;2 Division of Thoracic Surgery, Chiba Cancer Center;3 Department of Thoracic Surgery, International University of Health and Welfare School of Medicine;4 Division of Respiratory Diseases, Department of Internal Medicine, The Jikei University School of Medicine;5 Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School;6 Department of Diagnostic Imaging and Nuclear Medicine, Tokyo Women’s Medical University;7 Division of Respiratory Medicine, Saitama Medical University International Medical Center

关键词: Lung cancer;    idiopathic pulmonary fibrosis (IPF);    pirfenidone;    perioperative pirfenidone therapy;   

DOI  :  10.21037/jtd-22-535

学科分类：呼吸医学

来源: Pioneer Bioscience Publishing Company

【 摘 要 】

Background: Radical treatment for non-small cell lung cancer (NSCLC) combined with idiopathic pulmonary fibrosis (IPF) is challenging to plan due to the invasiveness of lung cancer and an acute exacerbation (AE) of IPF that is sometimes lethal. Methods: We intend to conduct the PIII-PEOPLE study (NEJ034), which is a phase III multicenter prospective randomized controlled clinical trial, to validate the effect of perioperative pirfenidone therapy (PPT), involving oral pirfenidone (600 mg) administration for 14 days after registration followed by oral pirfenidone (1,200 mg) for more than 14 days before surgery, with additional oral pirfenidone resumed and continued after surgery. Another group (control) will be allowed to perform any AE preventative treatment, excluding anti-fibrotic agents. Surgery without any preventative measures is also allowed in the control group. The primary endpoint is the IPF exacerbation rate within 30 days postoperatively. The data analysis will be performed in 2023–2024. Discussion: This trial will validate the perioperative AE suppression effect of PPT, and survival benefits including overall, cancer-free, and IP progression free survival due to PPT. It leads to the establishment of an optimized therapeutic strategy for NSCLC combined with IPF. Trial Registration: This trial has been registered at the UMIN Clinical Trials Registry as UMIN000029411 (http://www.umin.ac.jp/ctr/).

【 授权许可】

Unknown