Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449033
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2007-03-16
Brief Title:
A Phase III Randomized Double-blind Placebo Controlled Trial Comparing the Efficacy of Gemcitabine Cisplatin and Sorafenib to Gemcitabine Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer NSCLC
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase III Randomized Double-blind Placebo Controlled Trial Comparing the Efficacy of Gemcitabine Cisplatin and Sorafenib to Gemcitabine Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2015-04
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:
NEXUS
Brief Summary:
Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer NSCLC
Detailed Description:
During follow-up it was determined that there was one additional patient on placebo that was still receiving treatment as of 06 APR 2010 and therefore 10 patients data are reported in the current CSR addendum 6 in the sorafenib GC group and 4 in the placebo GC group and as before all in the ITT non-squamous population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2006-002688-26 | EUDRACT_NUMBER | None | None |