Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01828112
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2013-04-02
Brief Title:
LDK378 Versus Chemotherapy in ALK Rearranged ALK Positive Patients Previously Treated With Chemotherapy Platinum Doublet and Crizotinib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Multicenter Randomized Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged ALK-positive Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy Platinum Doublet and Crizotinib
Status:
COMPLETED
Status Verified Date:
2023-11
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:
The primary purpose of the study was to compare the antitumor activity of LDK378 vs chemotherapy in patients previously treated with chemotherapy platinum doublet and crizotinib Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease PD while also had the choice to continue with pemetrexed treatment
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 |
|---|---|---|---|
| 2012-005637-36 | EUDRACT_NUMBER | None | None |