A RANDOMIZED, MULTICENTER, PHASE III, OPEN-LABEL STUDY OF ALECTINIB VERSUS CRIZOTINIB IN TREATMENT-NAIVE ANAPLASTIC LYMPHOMA KINASE-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 20 Mar 2018
At a glance
- Drugs Alectinib (Primary) ; Crizotinib
- Indications Non-small cell lung cancer
- Focus Registrational; Therapeutic Use
- Acronyms ALEX
- Sponsors Roche
- 15 Mar 2018 Planned End Date changed from 31 Dec 2017 to 21 Jan 2020.
- 21 Dec 2017 According to a Chugai Pharmaceutical media release, the EC has approved Alecensa for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). In addition, the EU marketing authorisation for Alecensa has been switched from conditional approval (given in February 2017) to a full approval for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line).
- 06 Nov 2017 According to a Genentech media release, the FDA has converted Alecensa's initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line) to a full approval.