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

July 15, 2014 updated by: Transgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Belfort, France, 90016
        • Centre Hospitalier Belfort-Montbeliard
      • Besancon, France, 25000
        • CHU, Service de Pneumologie
      • Briey, France, 54151
        • Centre Hospitalier Général, Service de Pneumologie
      • Caen, France, 14076
        • Centre François Baclesse
      • Colmar, France, 68000
        • Hôpital Pasteur - Service de médecine F- Pavillon 43
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Marseille, France, 13273
        • Institut Paoli-Calmettes, Service d'oncologie médicale
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Rennes, France, 35033
        • CHRU Hopital de Pontchaillou
      • Strasbourg, France, 67100
        • Hôpital Lyautey - Service de Pneumologie
      • Vesoul, France, 70014
        • Centre Hospitalier de la Haute Saône, Service de Pneumologie - Allergologie
  • Germany
      • Gauting, Germany, 82131
        • Asklepios Fachkliniken, Zentrum für Pneumonologie
      • Heidelberg, Germany, 69126
        • Thoraxklinik Heidelberg
      • Köln, Germany, 51109
        • Lungenklinik Krankenhaus Merheim
      • Mannheim, Germany, 68167
        • Klinikum Mannheim der Ruprecht-Karls
      • Offenburg, Germany, 77654
        • Klinikum Offenburg, Medizinische Klinik II
  • Hungary
      • Székesfehérvár, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Korhaz
  • Poland
      • Bialystok, Poland, 15-540
        • Oddział II Chorób Płuc i Gruźlicy
      • Bydgoszcz, Poland, 85-326
        • Kujawsko-Pomorskie Centrum Pulmonologii
      • Krakow, Poland, 31-826
        • Oddział Chemioterapii
      • Otwock, Poland, 05-400
        • Oddział III Chorób Płuc i Gruźlicy
      • Poznan, Poland, 60-569
        • Oddział Onkologii Klinicznej
      • Wrocław, Poland, 53-439
        • Dolnośląskie Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma, or large cell carcinoma);
  • Histological documentation of MUC1 antigen expression on the primary tumor or on metastasis, as defined by a positive staining by immuno-histo-chemistry in at least 25% of the tumor cells in the conditions described in the technical documentation of the monoclonal antibody;
  • Patients will have stage IIIb "wet" (with pleural or pericardial effusion) or IV disease, with no prior systemic therapy for advanced disease except for adjuvant treatment. Prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted;
  • At least one measurable lesion by Computed Tomography (CT-scanner) according to WHO criteria (lesion accurately measured in two dimensions with longest diameter equal or greater to 10 mm with spiral CT scan);

  • Adequate hematological, hepatic, and renal function:

    • Hemoglobin >= 10.0 g/dL; WBC >= 3.0x10e9/L including neutrophils >= 1.5x10e9/L and total lymphocytes count >= 0.5x10e9/L; platelets count >= 100x10e9/L;
    • Bilirubin =< 2x the upper limit of normal and serum transaminases =< 3x the upper limit of normal;
    • Glomerular Filtration Rate higher than 60 ml/mn according to Cockcroft formula;
  • Performance status 0 or 1 on the ECOG scale (Appendix 2);
  • Minimum estimated life expectancy of 4 months;
  • Written informed consent from patient.

Exclusion Criteria:

  • Concomitant brain metastases. If previous brain metastases were treated, the absence of evolution is to be demonstrated by the MRI or scanner performed at baseline;
  • Prior history of other malignancy except basal cell carcinoma and intra-epithelial cervical cancer or other cancer with complete response since at least 5 years;
  • History of any form of systemic therapy for advanced non-small cell cancer of the lung except for (neo)adjuvant treatment;
  • Previous (within 4 weeks prior to day 1) or concomitant long term treatment with systemic steroids, immunosuppressive / immunomodulating drugs (e.g. Cyclosporine, corticoïds);
  • Positive serology for HIV or HCV; positive antigens for hepatitis B;
  • Serious concomitant medical disorder;
  • Major surgery within 4 weeks prior to day 1;
  • Patient with an organ allograft;
  • Allergy to eggs;
  • Participation in another experimental protocol during the study period, or within 4 weeks prior to day 1;
  • Pregnancy at the entry or women who are breast feeding;
  • Patient without adequate protection against pregnancy during the conduct of the study and for 3 months after the last injection of TG4010 and/or chemotherapy;
  • History of substance abuse;
  • Patient unable or unwilling to comply with the protocol requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
MVA-MUC1-IL2 in combination with 1st line Chemotherapy
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
Active Comparator: Arm 2
1st line Chemotherapy without a MVA-MUC1-IL2 combination
Drug: 1st line Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival at 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time to progression
Time Frame: 6 months
6 months
Response Rate according to WHO criteria
Time Frame: 6 months
6 months
Quality of life
Time Frame: every 6 weeks
every 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transgene

Investigators

  • Principal Investigator: Elisabeth QUOIX, M.D., Hôpital Lyautey, Service de Pneumologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 22, 2006

First Submitted That Met QC Criteria

December 23, 2006

First Posted (Estimate)

December 25, 2006

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG4010.09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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