Phase II basket study of brigatinib for ALK fusion-positive solid tumors: WJOG15221M/ALLBREAK (a decentralized clinical trial design)
fusion genes are identified by next-generation sequencing (NGS) or by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). Due to rapid enrollment, the target sample size was expanded to 28 patients. The primary endpoint is objective response rate confirmed by central assessment; secondary endpoints include duration of response, progression-free survival, overall survival, and safety.Clinical trial registration: jRCT2041210148 (https://jrct.mhlw.go.jp).
Authors
- Kan Yonemori (ORCID: https://orcid.org/0000-0002-7624-7611)
- Keigo Komine (ORCID: https://orcid.org/0000-0003-2502-3666)
- Masako Asayama
- Kazuaki Harada (ORCID: https://orcid.org/0000-0001-9577-1884)
- Satoshi Hamauchi (ORCID: https://orcid.org/0000-0002-9857-2095)
- Kentaro Tokumo (ORCID: https://orcid.org/0000-0002-6062-876X)
- Takuma Onoe (ORCID: https://orcid.org/0000-0003-3676-5294)
- Satomi Watanabe (ORCID: https://orcid.org/0000-0002-0487-8721)
- Tomoki Sakakida (ORCID: https://orcid.org/0000-0003-1913-7923)
- Waki Hosoda
- Hidetoshi Hayashi
- Taito Esaki
- Toshiki Masuishi (ORCID: https://orcid.org/0000-0003-1913-7923)
- Takao Fujisawa
- Yukihiko Hiroshima
- Hiroya Taniguchi
- Kei Muro
Institutions
- Kanagawa Prefectural Hospital Organization (JP)
- Kyoto Prefectural University of Medicine (JP)
- Shizuoka Cancer Center (JP)
- National Cancer Center (US)
- National Hospital Organization Kyushu Cancer Center (JP)
- Tohoku University Hospital (JP)
- Saitama Cancer Center (JP)
- Hiroshima University Hospital (JP)
- Aichi Cancer Center (JP)
- Hokkaido University Hospital (JP)
- National Cancer Center Hospital East (JP)
- Hyogo Prefectural Cancer Center (JP)
- Kanagawa Cancer Center
- Kindai University (JP)
Publication Details
- Journal
- Future Oncology
- Published
- 2026-04-15
- DOI
- https://doi.org/10.1080/14796694.2026.2658642
- Primary Topic
- Lung Cancer Treatments and Mutations
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Takeda Pharmaceutical Company