A Randomized, Open-label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for High DLL3 Expressing Small Cell Lung Cancer (SCLC) Subjects With First Relapse/Recurrence Following Front-Line Platinum-Based Chemotherapy (TAHOE)
Phase of Trial: Phase III
Latest Information Update: 08 Jan 2019
At a glance
- Drugs Rovalpituzumab tesirine (Primary) ; Dexamethasone; Topotecan
- Indications Small cell lung cancer
- Focus Registrational; Therapeutic Use
- Acronyms TAHOE
- Sponsors AbbVie
- 05 Dec 2018 According to an AbbVie media release, the Independent Data Monitoring Committee responsible for ongoing review of study data recommended enrolment to be stopped in this trial due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. The IDMC recommended that investigators and patients make individual decisions as to whether or not to continue treatment based on patient level response.
- 05 Dec 2018 Status changed from recruiting to suspended, according to an AbbVie media release.
- 10 Oct 2018 Planned End Date changed from 31 Jul 2020 to 30 Sep 2021.