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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001015-22-HU

Enrollment

140

Registered

2005-11-30

Start date

2006-03-02

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non Small Cell Lung Cancer

Interventions

Product Name: MVA-MUC1-IL2 Product Code: TG4010 Pharmaceutical Form: Solution for injection Other descriptive name: MVATG9931 Concentration type: not less then Concentration number: 10E8 pfu/ampoule-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed stage IIIB “wet” (with pleural or pericardic effusion) or IV non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma, or large cell carcinoma), positive for MUC1; - No prior systemic treatment for advanced disease; - With at least one measurable lesion evaluated by CT-scan according to WHO critera; - Performance Status 0 or 1 on the ECOG scale; - Minimum estimated life expectancy of 4 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - History of any form of systemic therapy for non-small cell carcinoma of the lung except for (neo)adjuvant treatment; - Concomitant brain metastasis; - History of other malignancy in the past 5 years except for basal cell carcinoma and intra-epithelial cervical neoplasia.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of TG4010 combined to chemotherapy in patients with advanced non small cell lung cancer. Efficacy will be assessed by progression free survival (PFS) at 6 months.;Secondary Objective: - To determine the response rate (RR), the time to progression (TTP) and the overall survival (OS); - To confirm the safety of TG4010 administered subcutaneously in combination with chemotherapy in this patient population; - To assess the immunological response; - To explore the plasma proteome profile.;Primary end point(s): 1/ Efficacy: - Primary endpoint: progression free survival at 6 months (PFS). - Secondary endpoints: response rate (RR) according to WHO criteria, time to progression (TTP) and overall survival (OS). 2/ Safety: Adverse events and serious adverse events. 3/ Immunology: Cellular immune response assessed by tetramer and immunophenotype analysis. 4/ Translational Research: Proteome analyses by mass spectrometry.	—

Measure

Time frame

Main Objective: To assess the efficacy of TG4010 combined to chemotherapy in patients with advanced non small cell lung cancer. Efficacy will be assessed by progression free survival (PFS) at 6 months.;Secondary Objective: - To determine the response rate (RR), the time to progression (TTP) and the overall survival (OS); - To confirm the safety of TG4010 administered subcutaneously in combination with chemotherapy in this patient population; - To assess the immunological response; - To explore the plasma proteome profile.;Primary end point(s): 1/ Efficacy: - Primary endpoint: progression free survival at 6 months (PFS). - Secondary endpoints: response rate (RR) according to WHO criteria, time to progression (TTP) and overall survival (OS). 2/ Safety: Adverse events and serious adverse events. 3/ Immunology: Cellular immune response assessed by tetramer and immunophenotype analysis. 4/ Translational Research: Proteome analyses by mass spectrometry.

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Countries

Germany, Hungary, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026