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Safety and Efficacy of Bojungikki-Tang in Advanced NSCLC Patients Receiving Treatment with Immune Checkpoint Inhibitors: Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Pilot Trial

Author

Listed:
  • Mi Mi Ko

    (KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea
    These authors contributed equally to this work.)

  • Mi-Kyung Jeong

    (KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea
    These authors contributed equally to this work.)

  • Chang Min Choi

    (Department of Pulmonary and Critical Care Medicine, Asan Medical Center, College of Medicine, University of Ulsan, Seoul 05505, Republic of Korea)

  • Seung Hyeun Lee

    (Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul 02447, Republic of Korea)

  • Jaemoo Chun

    (KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea)

  • Jin-Mu Yi

    (KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea)

  • Ho Jang

    (KM Data Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea)

  • Sung Yong Lee

    (Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul 08308, Republic of Korea)

Abstract

Cancer immunotherapy with immune checkpoint inhibitors (ICIs) is a major treatment option for several types of cancer, including non-small cell lung cancer (NSCLC). The proposed study aims to investigate the safety and efficacy of Bojungikki-tang (BJIKT) therapy (an herbal medicine) in patients with advanced NSCLC treated with ICIs. This multicenter, randomized, placebo-controlled pilot study will be performed at three academic hospitals. Thirty patients with advanced NSCLC, undergoing atezolizumab monotherapy as second- and subsequent-line treatment, will be recruited and randomly assigned to either BJIKT treatment (atezolizumab + BJIKT) or placebo (atezolizumab + placebo). The primary and secondary outcomes are the incidence of adverse events (AEs), including immune- related AEs (irAEs) and non-immune-related AEs (non-irAEs); and early termination rate, withdrawal period, symptom improvement of fatigue, and skeletal muscle loss, respectively. The exploratory outcomes are patient objective response rate and immune profile. This is an ongoing trial. Recruitment started on 25 March 2022 and is expected to be completed by 30 June 2023. This study will provide basic evidence for the safety profiles, including irAEs, of herbal medicine in patients with advanced NSCLC treated with ICIs.

Suggested Citation

  • Mi Mi Ko & Mi-Kyung Jeong & Chang Min Choi & Seung Hyeun Lee & Jaemoo Chun & Jin-Mu Yi & Ho Jang & Sung Yong Lee, 2023. "Safety and Efficacy of Bojungikki-Tang in Advanced NSCLC Patients Receiving Treatment with Immune Checkpoint Inhibitors: Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Pilot ," IJERPH, MDPI, vol. 20(5), pages 1-12, March.
    • Handle: RePEc:gam:jijerp:v:20:y:2023:i:5:p:4507-:d:1086645
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