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

Research output: Contribution to journalArticle

5 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 languageEnglish
Pages (from-to)317-320
Number of pages4
JournalJournal of Medical Investigation
Volume64
Issue number3-4
DOIs
Publication statusPublished - 2017

Fingerprint

Gene Fusion
Transfection
Lung Neoplasms
Non-Small Cell Lung Carcinoma
Fusion reactions
Genes
Cells
Patient treatment
Chemotherapy
Safety
CH5424802
Drug Therapy
Therapeutics

Keywords

  • Alectinib
  • Non-small cell lung cancer
  • RET fusion gene

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

Takeuchi, S., Murayama, T., Yoshimura, K., Kawakami, T., Takahara, S., Imai, Y., ... Yano, S. (2017). Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol. Journal of Medical Investigation, 64(3-4), 317-320. https://doi.org/10.2152/jmi.64.317

Phase I/II study of alectinib in lung cancer with RET fusion gene : Study protocol. / Takeuchi, Shinji; Murayama, Toshinori; Yoshimura, Kenichi; Kawakami, Takahiro; Takahara, Shizuko; Imai, Yasuhito; Kuribayashi, Yoshikazu; Nagase, Katsuhiko; Goto, Koichi; Nishio, Makoto; Hasegawa, Yoshinori; Satouchi, Miyako; Kiura, Katsuyuki; Seto, Takashi; Yano, Seiji.

In: Journal of Medical Investigation, Vol. 64, No. 3-4, 2017, p. 317-320.

Research output: Contribution to journalArticle

Takeuchi, S, Murayama, T, Yoshimura, K, Kawakami, T, Takahara, S, Imai, Y, Kuribayashi, Y, Nagase, K, Goto, K, Nishio, M, Hasegawa, Y, Satouchi, M, Kiura, K, Seto, T & Yano, S 2017, 'Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol', Journal of Medical Investigation, vol. 64, no. 3-4, pp. 317-320. https://doi.org/10.2152/jmi.64.317
Takeuchi S, Murayama T, Yoshimura K, Kawakami T, Takahara S, Imai Y et al. Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol. Journal of Medical Investigation. 2017;64(3-4):317-320. https://doi.org/10.2152/jmi.64.317
Takeuchi, Shinji ; Murayama, Toshinori ; Yoshimura, Kenichi ; Kawakami, Takahiro ; Takahara, Shizuko ; Imai, Yasuhito ; Kuribayashi, Yoshikazu ; Nagase, Katsuhiko ; Goto, Koichi ; Nishio, Makoto ; Hasegawa, Yoshinori ; Satouchi, Miyako ; Kiura, Katsuyuki ; Seto, Takashi ; Yano, Seiji. / Phase I/II study of alectinib in lung cancer with RET fusion gene : Study protocol. In: Journal of Medical Investigation. 2017 ; Vol. 64, No. 3-4. pp. 317-320.
@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",
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",

}

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

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

UR - http://www.scopus.com/inward/record.url?scp=85030260046&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85030260046&partnerID=8YFLogxK

U2 - 10.2152/jmi.64.317

DO - 10.2152/jmi.64.317

M3 - Article

C2 - 28955006

AN - SCOPUS:85030260046

VL - 64

SP - 317

EP - 320

JO - Journal of Medical Investigation

JF - Journal of Medical Investigation

SN - 1343-1420

IS - 3-4

ER -