A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX)
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX)
ClinicalTrials.gov ID: NCT02075840
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2024-02-13
Brief Summary:
This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.
Official Title:
Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Intervention / Treatment:
- Drug: Alectinib
- Drug: Crizotinib
| Category | Value |
|---|---|
| Study Start (Actual) | 2014-08-19 |
| Primary Completion (Actual) | 2024-12-31 |
| Study Completion (Estimated) | 2024-12-31 |
| Enrollment (Actual) | 303 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
BO28984
2013-004133-33 (EudraCT Number) |