Phase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Naïve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)

Yuko Tsuchiya-Kawano,1 Yoshimasa Shiraishi,2 Fumiaki Kiyomi,3 Isamu Okamoto2 1Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan; 2Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; 3Statistics...

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Autores principales:	Tsuchiya-Kawano Y, Shiraishi Y, Kiyomi F, Okamoto I
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	clinical trial nsclc nivolumab plus ipilimumab brain metastases intracranial response rate Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/7b71322540c543f7a6dd2e4c6e803a2a
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spelling	oai:doaj.org-article:7b71322540c543f7a6dd2e4c6e803a2a2021-11-11T18:22:26ZPhase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Naïve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)1179-1322https://doaj.org/article/7b71322540c543f7a6dd2e4c6e803a2a2021-11-01T00:00:00Zhttps://www.dovepress.com/phase-ii-study-of-nivolumab-plus-ipilimumab-with-platinum-based-chemot-peer-reviewed-fulltext-article-CMARhttps://doaj.org/toc/1179-1322Yuko Tsuchiya-Kawano,1 Yoshimasa Shiraishi,2 Fumiaki Kiyomi,3 Isamu Okamoto2 1Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan; 2Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; 3Statistics and Data Center, Clinical Research Support Center Kyushu, Fukuoka, JapanCorrespondence: Isamu OkamotoResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JapanTel +81-92-642-5378Fax +81-92-642-5390Email okamoto.isamu.290@m.kyushu-u.ac.jpAbstract: The standard of care for advanced non-small cell lung cancer (NSCLC) without known driver oncogenes is immune checkpoint inhibitor (ICI) therapy combined with platinum-based chemotherapy. About 20% of patients with advanced NSCLC have brain metastases, which are related to poor prognosis. However, the effect of ICI therapy combined with platinum-based chemotherapy on untreated brain metastases derived from NSCLC remains unclear. The primary endpoint of this study is intracranial response rate as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST) for brain metastases of ≥ 5 mm as target lesions. Eligible patients are 20 years of age or older with chemotherapy-naïve advanced NSCLC and at least one brain metastasis ≥ 5 mm in size that has not been previously treated. Patients receive nivolumab plus ipilimumab intravenously combined with histology-based platinum doublet chemotherapy (two cycles). Individuals with known genetic driver alterations such as those affecting EGFR or ALK are excluded. Planned enrollment is 30 patients over 2.5 years at 27 oncology facilities in Japan. This is the first prospective study to focus on the intracranial response to ICI therapy combined with platinum-based chemotherapy in patients with untreated brain metastases derived from NSCLC. If the study demonstrates intracranial efficacy for this patient population, then this regimen has the potential to become a new treatment option for such individuals.Keywords: clinical trial, NSCLC, nivolumab plus ipilimumab, brain metastases, intracranial response rateTsuchiya-Kawano YShiraishi YKiyomi FOkamoto IDove Medical Pressarticleclinical trialnsclcnivolumab plus ipilimumabbrain metastasesintracranial response rateNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancer Management and Research, Vol Volume 13, Pp 8489-8493 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	clinical trial nsclc nivolumab plus ipilimumab brain metastases intracranial response rate Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	clinical trial nsclc nivolumab plus ipilimumab brain metastases intracranial response rate Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Tsuchiya-Kawano Y Shiraishi Y Kiyomi F Okamoto I Phase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Naïve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)
description	Yuko Tsuchiya-Kawano,1 Yoshimasa Shiraishi,2 Fumiaki Kiyomi,3 Isamu Okamoto2 1Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan; 2Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; 3Statistics and Data Center, Clinical Research Support Center Kyushu, Fukuoka, JapanCorrespondence: Isamu OkamotoResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JapanTel +81-92-642-5378Fax +81-92-642-5390Email okamoto.isamu.290@m.kyushu-u.ac.jpAbstract: The standard of care for advanced non-small cell lung cancer (NSCLC) without known driver oncogenes is immune checkpoint inhibitor (ICI) therapy combined with platinum-based chemotherapy. About 20% of patients with advanced NSCLC have brain metastases, which are related to poor prognosis. However, the effect of ICI therapy combined with platinum-based chemotherapy on untreated brain metastases derived from NSCLC remains unclear. The primary endpoint of this study is intracranial response rate as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST) for brain metastases of ≥ 5 mm as target lesions. Eligible patients are 20 years of age or older with chemotherapy-naïve advanced NSCLC and at least one brain metastasis ≥ 5 mm in size that has not been previously treated. Patients receive nivolumab plus ipilimumab intravenously combined with histology-based platinum doublet chemotherapy (two cycles). Individuals with known genetic driver alterations such as those affecting EGFR or ALK are excluded. Planned enrollment is 30 patients over 2.5 years at 27 oncology facilities in Japan. This is the first prospective study to focus on the intracranial response to ICI therapy combined with platinum-based chemotherapy in patients with untreated brain metastases derived from NSCLC. If the study demonstrates intracranial efficacy for this patient population, then this regimen has the potential to become a new treatment option for such individuals.Keywords: clinical trial, NSCLC, nivolumab plus ipilimumab, brain metastases, intracranial response rate
format	article
author	Tsuchiya-Kawano Y Shiraishi Y Kiyomi F Okamoto I
author_facet	Tsuchiya-Kawano Y Shiraishi Y Kiyomi F Okamoto I
author_sort	Tsuchiya-Kawano Y
title	Phase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Naïve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)
title_short	Phase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Naïve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)
title_full	Phase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Naïve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)
title_fullStr	Phase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Naïve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)
title_full_unstemmed	Phase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Naïve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)
title_sort	phase ii study of nivolumab plus ipilimumab with platinum-based chemotherapy for treatment-naïve advanced non-small cell lung cancer with untreated brain metastases: nike trial (logik2004)
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/7b71322540c543f7a6dd2e4c6e803a2a
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Phase II Study of Nivolumab Plus Ipilimumab with Platinum-Based Chemotherapy for Treatment-Na&iuml;ve Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases: NIke Trial (LOGiK2004)

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