Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415818
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2006-12-22
Brief Title:
Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Transgene
Organization:
Transgene
Study Overview
Official Title:
A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010MVA-MUC1-IL2 as an Adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-07
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:
None
Brief Summary:
The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer
Detailed Description:
In the experimental arm patients receive subcutaneous injections of TG4010 at the dose of 108 pfu in combination with chemotherapy treatment whereas patients in the control arm receive chemotherapy alone The chemotherapy associates cisplatin and gemcitabine and is given for up to 6 cycles or progressive disease whichever occurs first
TG4010 is administered once per week for 6 weeks then once every 3 weeks in combination with chemotherapy and thereafter as monotherapy until documentation of progressive disease
Tumor response will be evaluated every 6 weeks by a CT-scan and results will be available before starting an additional treatment period of 6 weeks The tumor response taken into account will be for each patient the best overall response obtained during the study
The endpoint of the study is based on Progression Free Survival PFS at 6 months
TG4010 is administered once per week for 6 weeks then once every 3 weeks in combination with chemotherapy and thereafter as monotherapy until documentation of progressive disease
Tumor response will be evaluated every 6 weeks by a CT-scan and results will be available before starting an additional treatment period of 6 weeks The tumor response taken into account will be for each patient the best overall response obtained during the study
The endpoint of the study is based on Progression Free Survival PFS at 6 months
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