Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-01-01 @ 1:04 PM
Study NCT ID:
NCT01209650
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2016-11-10
First Post:
2010-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LUX Lung Special Access Scheme Australia Named Patient Use (NPU)
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Expanded Access Program BIBW 2992 for Non Small Cell Lung Cancer ( NSCLC) Last Line Treatment
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2016-11
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 program will provide early access to the investigational drug BIBW 2992 to treat patients with advanced NSCLC who have failed at least 12 weeks on erlotinib or gefitinib.
The Compassionate Use Programme will also provide additional safety and efficacy information on BIBW 2992 use.
Named Patient Use (NPU)
The Compassionate Use Programme will also provide additional safety and efficacy information on BIBW 2992 use.
Named Patient Use (NPU)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: