Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00415818|
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Biological: MVA-MUC1-IL2 Drug: 1st line Chemotherapy||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010(MVA-MUC1-IL2) as an Adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Experimental: Arm 1
MVA-MUC1-IL2 in combination with 1st line Chemotherapy
Dose of 10exp8 plaque forming units (pfu).
Arm 1 and Arm 2 Intravenous CT: cisplatin (75mg/m² at Day 1) and gemcitabine (1250mg/m² at Days 1 and 8) every 3 weeks, for up to six cycles or until progressive disease, whichever occurred first.
Drug: 1st line Chemotherapy
Active Comparator: Arm 2
1st line Chemotherapy without a MVA-MUC1-IL2 combination
Drug: 1st line Chemotherapy
- Progression free survival at 6 months [ Time Frame: 6 months ]
- Response Rate according to WHO criteria [ Time Frame: 6 months ]
- Time to progression [ Time Frame: 6 months ]
- Overall survival
- Quality of life [ Time Frame: every 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415818
|Principal Investigator:||Elisabeth QUOIX, M.D.||Hôpital Lyautey, Service de Pneumologie|