Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02737501
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2016-03-30
Brief Title:
ALTA-1L Study A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive ALK Advanced Non-small Cell Lung Cancer NSCLC Participants
Sponsor:
Ariad Pharmaceuticals
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Multicenter Open-label Study of Brigatinib AP26113 Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-07
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:
ALTA-1L
Brief Summary:
The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK locally advanced or metastatic non-small cell lung cancer NSCLC participants naive to ALK inhibitors as evidenced by progression-free survival PFS
Detailed Description:
The purpose of this phase III randomized open-label comparative multicenter international study is to compare the efficacy and safety of brigatinib to that of crizotinib in ALK locally advanced or metastatic NSCLC participants who have not previously been treated with an ALK inhibitor Participants will be stratified by the presence of CNS metastases at baseline and prior chemotherapy used for locally advanced or metastatic disease Participants will be randomized in a 11 ratio to receive either brigatinib 90 mg orally once daily QD for 7 days then a 180 mg orally QD or crizotinib 250 mg orally twice daily BID Participants will receive treatment until disease progression intolerable toxicity consent withdrawal or death Crossover from crizotinib to brigatinib is also permitted
The total estimated duration of the study is at least 45 years including 15 years to accrue participants with at least 3 years for treatment and follow-up
The total estimated duration of the study is at least 45 years including 15 years to accrue participants with at least 3 years for treatment and follow-up
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 |
|---|---|---|---|
| 2015-003447-19 | EUDRACT_NUMBER | WHO | None |
| U1111-1210-4363 | OTHER | None | None |