Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157209
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2005-09-08
Brief Title:
Phase 2b Randomized Controlled Study of Tecemotide L-BLP25 for Immunotherapy of NSCLC Non-Small Cell Lung Cancer
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
A Multicenter Phase IIb Randomised Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
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 is a prospective open label controlled randomized study to test the safety and efficacy of active specific immunotherapy with tecemotide L-BLP25 for the treatment of subjects with Stage IIIB or Stage IV non-small cell lung cancer NSCLC To be eligible subjects entering the trial will have to demonstrate either stable disease or a clinical response after first-line treatment chemotherapy alone or chemotherapy and radiotherapy and have an Eastern Cooperative Oncology Group ECOG performance status of 0 1 or 2 Following a 3 week washout period subjects will be stratified by disease status either Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV and randomized to either best supportive care BSC plus tecemotide L-BLP25 treatment or BSC alone
Detailed Description:
None
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