Ignite Creation Date:
2024-05-06 @ 7:48 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02604342
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2015-11-11
Brief Title:
Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase ALK-Positive Advanced Non-Small Cell Lung Cancer NSCLC Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Randomized Multicenter Phase III Open-Label Study of Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer Patients Previously Treated With Platinum-Based Chemotherapy and Crizotinib
Status:
COMPLETED
Status Verified Date:
2019-10
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:
None
Brief Summary:
This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib as measured by investigator-assessed progression-free survival PFS and to evaluate and compare between treatment groups the central nervous system CNS objective response rate C-ORR in participants with measurable CNS metastases at baseline as assessed by an Independent Review Committee IRC
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 |
|---|---|---|---|
| 2015-000634-29 | EUDRACT_NUMBER | None | None |