Artemis: A Multicenter, Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of First-Line Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas

Yusuke Okuma; Shogo Nomura; Jun Sakakibara-Konishi; Yoko Tsukita; Shuji Murakami; Yukio Hosomi; Yuichi Tambo; Yoshihito Kogure; Hiroshige Yoshioka; Motohiro Tamiya; Kiichiro Ninomiya; Eiji Iwama

doi:10.1016/j.cllc.2024.02.002

Artemis: A Multicenter, Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of First-Line Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas

Clin Lung Cancer. 2024 Feb 8:S1525-7304(24)00013-5. doi: 10.1016/j.cllc.2024.02.002. Online ahead of print.

Authors

Affiliations

¹ Department of Thoracic Oncology, National Cancer Center Hospital, Chuo, Japan. Electronic address: yokuma@ncc.go.jp.
² Department of Biostatistics and Bioinformatics, The University of Tokyo, Tokyo, Japan.
³ Department of Respiratory Medicine, Faculty of Medicine, Hokkaido University, Hokkaido, Japan.
⁴ Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
⁵ Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
⁶ Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
⁷ Department of Respiratory Medicine, Kanazawa University Hospital, Kanazawa, Ishikawa, Japan.
⁸ Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
⁹ Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan.
¹⁰ Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.
¹¹ Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
¹² Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

PMID: 38413246
DOI: 10.1016/j.cllc.2024.02.002

Abstract

Background: Thymic carcinoma is a rare cancer with an aggressive clinical presentation and no organotypic symptoms. Despite using platinum-based chemotherapy as first-line treatment, the prognosis remains poor, necessitating a novel therapeutic strategy.

Methods: The artemis trial is a Phase II, single-arm, multicenter study designed to evaluate the efficacy and safety of carboplatin, paclitaxel, lenvatinib, and pembrolizumab as first-line chemotherapy for patients with advanced or recurrent thymic carcinoma. A total of 35 patients will be enrolled in this study and will receive induction therapy every 3 weeks for up to 4 cycles, followed by pembrolizumab every 3 weeks, and daily lenvatinib as maintenance therapy for up to 31 cycles (for 2 years). Lenvatinib will be continued until disease progression or unacceptable toxicity based on the discretion of the attending physician.

Conclusion: The primary endpoint of the study is the objective response rate, with secondary endpoints including progression-free survival, overall survival, duration of response, disease control rate, and safety profile.

Trial registration: ClinicalTrials.gov NCT05832827 Registered on April 27, 2023, https://classic.

Clinicaltrials: gov/ct2/show/NCT05832827. Japan Registry of Clinical Trials (jRCT), jRCT2031230114. Registered on May 22, 2023, https://jrct.niph.go.jp/latest-detail/jRCT2031230114.

Keywords: Anti-PD-L; Chemotherapy; Immune checkpoint inhibitor; Lenvatinib; Thymic carcinoma.

Associated data

ClinicalTrials.gov/NCT05832827