Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol

Shinji Takeuchi; Toshinori Murayama; Kenichi Yoshimura; Takahiro Kawakami; Shizuko Takahara; Yasuhito Imai; Yoshikazu Kuribayashi; Katsuhiko Nagase; Koichi Goto; Makoto Nishio; Yoshinori Hasegawa; Miyako Satouchi; Katsuyuki Kiura; Takashi Seto; Seiji Yano

doi:10.2152/jmi.64.317

Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol

Shinji Takeuchi, Toshinori Murayama, Kenichi Yoshimura, Takahiro Kawakami, Shizuko Takahara, Yasuhito Imai, Yoshikazu Kuribayashi, Katsuhiko Nagase, Koichi Goto, Makoto Nishio, Yoshinori Hasegawa, Miyako Satouchi, Katsuyuki Kiura, Takashi Seto, Seiji Yano

University Hospital

Research output: Contribution to journal › Article › peer-review

15 Citations (Scopus)

Abstract

Background: The rearranged during transfection (RET) fusion gene was discovered as a driver on-cogene in 1-2% of non-small cell lung cancers (NSCLCs). Alectinib is an approved anaplastic lymphoma kinase (ALK) inhibitor that may also be effective for RET fusion-positive NSCLC. Methods/Design: RET fusion-positive NSCLC patients treated with at least one regimen of chemotherapy are being recruited. In step 1, alectinib (600 or 450 mg, twice daily) will be administered following a 3+3 design. The primary endpoint is safety. In step 2, alectinib will be administered at the recommended dose (RD) defined by step 1. The primary endpoint is the response rate of RET inhibitor treatment-naïve patients. Conclusion: This is the first study to investigate the safety and preliminary efficacy of alectinib in RET fusion-positive NSCLC patients. If successful, alectinib treatment may lead to substantial and important changes in the management of NSCLC with RET fusion genes.

Original language	English
Pages (from-to)	317-320
Number of pages	4
Journal	Journal of Medical Investigation
Volume	64
Issue number	3-4
DOIs	https://doi.org/10.2152/jmi.64.317
Publication status	Published - 2017

Keywords

Alectinib
Non-small cell lung cancer
RET fusion gene

ASJC Scopus subject areas

Biochemistry, Genetics and Molecular Biology(all)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.2152/jmi.64.317

Cite this

@article{6718566703d44e71b456a71ce3d942e6,

title = "Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol",

abstract = "Background: The rearranged during transfection (RET) fusion gene was discovered as a driver on-cogene in 1-2% of non-small cell lung cancers (NSCLCs). Alectinib is an approved anaplastic lymphoma kinase (ALK) inhibitor that may also be effective for RET fusion-positive NSCLC. Methods/Design: RET fusion-positive NSCLC patients treated with at least one regimen of chemotherapy are being recruited. In step 1, alectinib (600 or 450 mg, twice daily) will be administered following a 3+3 design. The primary endpoint is safety. In step 2, alectinib will be administered at the recommended dose (RD) defined by step 1. The primary endpoint is the response rate of RET inhibitor treatment-na{\"i}ve patients. Conclusion: This is the first study to investigate the safety and preliminary efficacy of alectinib in RET fusion-positive NSCLC patients. If successful, alectinib treatment may lead to substantial and important changes in the management of NSCLC with RET fusion genes.",

keywords = "Alectinib, Non-small cell lung cancer, RET fusion gene",

author = "Shinji Takeuchi and Toshinori Murayama and Kenichi Yoshimura and Takahiro Kawakami and Shizuko Takahara and Yasuhito Imai and Yoshikazu Kuribayashi and Katsuhiko Nagase and Koichi Goto and Makoto Nishio and Yoshinori Hasegawa and Miyako Satouchi and Katsuyuki Kiura and Takashi Seto and Seiji Yano",

note = "Funding Information: Seiji Yano, Koichi Goto, Makoto Nishio, Yoshinori Hasegawa, Miyako Satouchi, Katsuyuki Kiura, and Takashi Seto have received speaker honoraria and research funding from Chugai Pharmaceutical Co, Ltd. All remaining authors have declared no conflicts of interest. Funding Information: This study is supported by grants from the Japan Agency for Medical Research and Development (AMED) : Grant numbers 15Ack0106147h0001 and 16ck0106147h0002 (to SY). Publisher Copyright: {\textcopyright} 2017, University of Tokushima. All rights reserved.",

year = "2017",

doi = "10.2152/jmi.64.317",

language = "English",

volume = "64",

pages = "317--320",

journal = "Journal of Medical Investigation",

issn = "1343-1420",

publisher = "University of Tokushima",

number = "3-4",

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TY - JOUR

T1 - Phase I/II study of alectinib in lung cancer with RET fusion gene

T2 - Study protocol

AU - Takeuchi, Shinji

AU - Murayama, Toshinori

AU - Yoshimura, Kenichi

AU - Kawakami, Takahiro

AU - Takahara, Shizuko

AU - Imai, Yasuhito

AU - Kuribayashi, Yoshikazu

AU - Nagase, Katsuhiko

AU - Goto, Koichi

AU - Nishio, Makoto

AU - Hasegawa, Yoshinori

AU - Satouchi, Miyako

AU - Kiura, Katsuyuki

AU - Seto, Takashi

AU - Yano, Seiji

N1 - Funding Information: Seiji Yano, Koichi Goto, Makoto Nishio, Yoshinori Hasegawa, Miyako Satouchi, Katsuyuki Kiura, and Takashi Seto have received speaker honoraria and research funding from Chugai Pharmaceutical Co, Ltd. All remaining authors have declared no conflicts of interest. Funding Information: This study is supported by grants from the Japan Agency for Medical Research and Development (AMED) : Grant numbers 15Ack0106147h0001 and 16ck0106147h0002 (to SY). Publisher Copyright: © 2017, University of Tokushima. All rights reserved.

PY - 2017

Y1 - 2017

N2 - Background: The rearranged during transfection (RET) fusion gene was discovered as a driver on-cogene in 1-2% of non-small cell lung cancers (NSCLCs). Alectinib is an approved anaplastic lymphoma kinase (ALK) inhibitor that may also be effective for RET fusion-positive NSCLC. Methods/Design: RET fusion-positive NSCLC patients treated with at least one regimen of chemotherapy are being recruited. In step 1, alectinib (600 or 450 mg, twice daily) will be administered following a 3+3 design. The primary endpoint is safety. In step 2, alectinib will be administered at the recommended dose (RD) defined by step 1. The primary endpoint is the response rate of RET inhibitor treatment-naïve patients. Conclusion: This is the first study to investigate the safety and preliminary efficacy of alectinib in RET fusion-positive NSCLC patients. If successful, alectinib treatment may lead to substantial and important changes in the management of NSCLC with RET fusion genes.

AB - Background: The rearranged during transfection (RET) fusion gene was discovered as a driver on-cogene in 1-2% of non-small cell lung cancers (NSCLCs). Alectinib is an approved anaplastic lymphoma kinase (ALK) inhibitor that may also be effective for RET fusion-positive NSCLC. Methods/Design: RET fusion-positive NSCLC patients treated with at least one regimen of chemotherapy are being recruited. In step 1, alectinib (600 or 450 mg, twice daily) will be administered following a 3+3 design. The primary endpoint is safety. In step 2, alectinib will be administered at the recommended dose (RD) defined by step 1. The primary endpoint is the response rate of RET inhibitor treatment-naïve patients. Conclusion: This is the first study to investigate the safety and preliminary efficacy of alectinib in RET fusion-positive NSCLC patients. If successful, alectinib treatment may lead to substantial and important changes in the management of NSCLC with RET fusion genes.

KW - Alectinib

KW - Non-small cell lung cancer

KW - RET fusion gene

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JF - Journal of Medical Investigation

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ER -

Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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