@article{oai:kanazawa-u.repo.nii.ac.jp:00043168, author = {竹内, 伸司 and 村山, 敏典 and 吉村, 健一 and 川上, 貴裕 and 髙原, 志津子 and 今井, 康人 and 栗林, 義和 and 長瀬, 克彦 and 矢野, 聖二 and Takeuchi, Shinji and Murayama, Toshinori and Yoshimura, Kenichi and Kawakami, Takahiro and Takahara, Shizuko and Imai, Yasuhito and Kuribayashi, Yoshikazu and Nagase, Katsuhiko and Goto, Koichi and Nishio, Makoto and Hasegawa, Yoshinori and Satouchi, Miyako and Kiura, Katsuyuki and Seto, Takashi and Yano, Seiji}, issue = {3-4}, journal = {Journal of Medical Investigation}, month = {}, note = {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. © 2017, University of Tokushima. All rights reserved., 金沢大学附属病院がんセンター}, pages = {317--320}, title = {Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol}, volume = {64}, year = {2017} }