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

NCT00415818 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2014-07-16

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

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

Sponsors & Collaborators

  • Transgene

    lead INDUSTRY

Principal Investigators

  • Elisabeth QUOIX, M.D. · Hôpital Lyautey, Service de Pneumologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • France
  • Germany
  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00415818 on ClinicalTrials.gov