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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415818
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE December 22, 2006
First Posted Date  ICMJE December 25, 2006
Last Update Posted Date July 16, 2014
Study Start Date  ICMJE December 2005
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2010)
Progression free survival at 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2006)
Progression free survival at 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2006)
  • Response Rate according to WHO criteria
  • Time to progression
  • Overall survival
  • Quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Biological: MVA-MUC1-IL2


    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
Study Arms  ICMJE
  • Experimental: Arm 1
    MVA-MUC1-IL2 in combination with 1st line Chemotherapy
    • Biological: MVA-MUC1-IL2
    • Drug: 1st line Chemotherapy
  • Active Comparator: Arm 2
    1st line Chemotherapy without a MVA-MUC1-IL2 combination
    Intervention: Drug: 1st line Chemotherapy
Publications * Quoix E, Ramlau R, Westeel V, Papai Z, Madroszyk A, Riviere A, Koralewski P, Breton JL, Stoelben E, Braun D, Debieuvre D, Lena H, Buyse M, Chenard MP, Acres B, Lacoste G, Bastien B, Tavernaro A, Bizouarne N, Bonnefoy JY, Limacher JM. Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial. Lancet Oncol. 2011 Nov;12(12):1125-33. doi: 10.1016/S1470-2045(11)70259-5. Epub 2011 Oct 21.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2014)
Original Enrollment  ICMJE
 (submitted: December 23, 2006)
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Hungary,   Poland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00415818
Other Study ID Numbers  ICMJE TG4010.09
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Transgene
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Transgene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elisabeth QUOIX, M.D. Hôpital Lyautey, Service de Pneumologie
PRS Account Transgene
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP