Ignite Creation Date:
2024-05-06 @ 2:35 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02075840
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2014-02-27
Brief Title:
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALEX
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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-004133-33 | EUDRACT_NUMBER | None | None |