NCT00415818

Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Transgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
BIOLOGICAL	MVA-MUC1-IL2	MVA-MUC1-IL2: Dose of 10exp8 plaque forming units (pfu). Chemotherapy: 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

Timeline

• Start date: 2005-12-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2006-12-25
• Last updated: 2014-07-16

Locations

23 sites across 4 countries: France, Germany, Hungary, Poland